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Second ASCT Has a Role in Relapsed Multiple Myeloma After First Transplant – Cancer Therapy Advisor

The landscape of treatment for relapsed multiple myeloma has evolved in recent years. Second salvage autologous hematopoietic stem cell transplantation (AHCT) remains an option in these patients, but its use varies widely, according to a recently published letter to the editor.

Choosing therapy in relapsed multiple myeloma is becoming increasingly complex in the crowded space of emerging and existing therapies, the researchers wrote.

To assess the use of second AHCT, researchers from the Medical College of Wisconsin and the University of Arkansas examined outcomes of 975 patients who underwent second transplant between 2010 and 2015 in the United States and Canada after relapse following first transplant.

With a median follow-up of 38 months, the rate of nonrelapse mortality was 1% at day 100, 1% at day 1 year, and 2% at 3 years. Cumulative incidence of relapse/progression at 1 year was 49%, increasing to 84% at 3 years.

Those patients who relapsed 3 years or later after first transplant had significantly lower incidence of relapse or progression after second transplant compared with those patients who relapsed between 24 and 35 months after first transplant (P =.02).

Additionally, those patients who relapsed 3 years or later after first transplant had significantly better progression-free (P =.01) and overall survival (P =.02) compared with those who relapsed earlier.

Disease status prior to second transplant was prognostic for relapse/progression, progression-free survival, and overall survival. Those patients who achieved very good partial response or better prior to second transplant had lower risk for relapse/progression and better progression-free survival compared with patients with partial response or stable disease.

The outcomes reported in our study are comparable with some of the new approved FDA regimens in that space, the researchers wrote.

Reference

Dhakal B, DSouza A, Kleman A, et al. Salvage second transplantation in relapsed multiple myeloma. Leukemia. Published August 4, 2020. doi:10.1038/s41375-020-1005-8

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Second ASCT Has a Role in Relapsed Multiple Myeloma After First Transplant - Cancer Therapy Advisor

McCloskey Explores Merits of Targeted Treatments and HMAs in MDS – Targeted Oncology

The options for targeted therapy and treatment with hypomethylating agents was discussed during a virtual Case Based Peer Perspectives event, which highlighted the case of a 75-year-old male patient with myelodysplastic syndromes (MDS). The discussion was led by James K. McCloskey II, MD, a medical oncologist, Division of Leukemia, Adult Blood and Marrow Stem Cell Transplantation Program, John Theurer Cancer Center, at Hackensack Meridian Health.

Targeted Oncology: What are the treatment regimens for the patient who isnt a candidate for induction therapy, according to the National Comprehensive Cancer Network (NCCN) guidelines?

MCCLOSKEY: For patients who are not candidates for induction therapy, the NCCN suggests venetoclax [Venclexta] in combination with HMA [hypomethylating agents] or LDAC [cladribine plus low-dose cytarabine], HMA alone, glasdegib [Daurismo] in combination with LDAC, LDAC alone, and Mylotarg [gemtuzumab ozogamicin].

What was the rationale for developing the liposomal combination of daunorubicin and cytarabine (Vyxeos) for this patient population?

This is a liposomal formulation of daunorubicin and cytarabine. I think the take-home point [regarding] the design of the drug is that the mechanism of action does not promote less toxicity but more effectiveness.

In preclinical models, we [found] that if we can administer anthracycline and cytarabine specifically in a 1:5 ratio, this is when we get the most potent antileukemic effect. The drug was designed to deliver that ratio and maintain that ratio in circulation.

The drug was approved based on a phase 3 randomized study [NCT01696084] that evaluated newly diagnosed patients with either treatment-related or secondary AML. These were patients between the ages of 60 and 75. The patients were deemed fit for intensive therapy, so their ECOG performance status was 0 to 2.

For this case, the patients cardiac events are concerning, although we dont know the circumstances under which he underwent stent placement. Otherwise, hes fitting into this category of patient. He specifically had MDS with prior HMA exposure. Hes 75, [which is] the upper age limit for patients in the study.

In this phase 3 trial, patients were randomized into treatment either with CPX-351 [n = 153] or 7 + 3 [n = 156]. They then were followed for treatment response. The patients who achieved a remission at any point and were eligible for transplant proceeded to transplant. Patients who failed to respond could receive salvage therapy. And those patients who achieved a response could go on to consolidation. At any point during the trial, patients could proceed to transplant.

An important consideration is that patients did not receive HiDAC [high-dose cytarabine] consolidation. They received 5 + 2, which is a European approach to treatment.

The FDA recommended the dosing description for the agent be 44 mg of daunorubicin and 100 mg/m of cytarabine. This formulation emphasizes the presence of the anthracycline.

What was the approval of this regimen based on?

The drug was approved based on overall survival data and investigators reported improved CR [complete response] rates. In the trial, 37% of patients experienced CR in the Vyxeos arm compared with 25% of patients in the control arm. If you consider CRis [complete remission with incomplete hematologic recovery], thats 47% for the Vyxeos arm compared with 33% for the control arm.

This did result in improved overall survival. Overall survival in the Vyxeos arm was 9.56 months compared with 5.95 months in the standard of care arm 7 + 3 [HR, 0.69; P = .003]. Patients who were treated with Vyxeos achieved the survival benefit whether they were in the older age group, between 70 and 75, or patients under the age of 75. Even those older patients did receive the survival benefit.

How does this affect consolidation and transplant?

If we follow the data out, it appears that Vyxeos improved outcomes both during consolidation with chemotherapy but also with patients who proceeded to stem cell transplant.

I think its important to note that this is post hoc analysis of the data, so these werent predefined groups. They were biased by the fact that these are responders.

Survival for patients who underwent consolidation with Vyxeos was 25 months compared with 8.5 months for 5 + 2. As we start to look at those patients who responded, we really see a significant benefit there. Looking at the impact [of Vyxeos] on transplant, among the patients who had a transplant, investigators reported more success getting folks to transplant in the Vyxeos arm: 49 patients in the Vyxeos arm compared with 32 patients in the control arm.

For patients who went to transplant in remission, it didnt matter which treatment regimen they received. The patients who received Vyxeos appeared to do better, with a median overall survival of 24 months compared with 12 months.

How does the safety profile of Vyxeos compare with standard induction?

I think most of the toxicities reported with Vyxeos are similar to what we expect to see with induction. In fact, the toxicities across the board are comparable, with no significant difference in cardiac toxicity and similar rates of infectious complications despite a delayed count recovery.

As you know, Vyxeos does often come with the downside of having delayed count recovery, but interestingly, we did not see increased risk of death from infection during that time. In terms of serious adverse effects, these 2 regimens are similar.

How was the dose for venetoclax determined?

The phase 1 study [NCT02203773] led by Dr DiNardo and colleagues evaluated venetoclax up to 800 mg in combination with both decitabine and Vidaza [azacitidine]. Its important to note that all the patients in the trial were HMA nave.

We did recently receive notice that the phase 3 data, published in Blood, which evaluated venetoclax plus azacitidine versus azacitidine alone, did meet its primary end point. What was striking was the remarkable response rate. For the elderly patient population who are unfit for transplant, the CR and CRi rates were 60% or 70%.

In terms of toxicity, there were few grade 3 and 4 toxicities, and not as many issues as we saw with the induction therapy that I previously mentioned.

But there were some concerns: 32% rate of febrile neutropenia, 12% pneumonia, 10% bacteremia. These occurred in a patient population that was less fit than the folks we just discussed and a little older in general.

What treatment options are available for patients with AML and high-risk MDS?

You might consider glasdegib, which we evaluated in clinical trials. We have used this in limited numbers of patients following the drugs approval.

If youre not familiar with glasdegib, its an inhibitor of the hedgehog pathway that targets the leukemia stem cell. It was studied in the BRIGHT study [NCT01546038]. This was a phase 2 randomized trial of patients with AML and high-risk MDS. Patients were randomized to either LDAC alone or LDAC in combination with glasdegib in a 2-to-1 fashion.d in the BRIGHT study [NCT01546038]. This was a phase 2 randomized trial of patients with AML and high-risk MDS. Patients were randomized to either LDAC alone or LDAC in combination with glasdegib in a 2-to-1 fashion.

The trial did include patients who had prior exposure to HMAs and, in fact, a substantial portion of these patients had been treated previously with HMA. The drug was approved based on the survival data around the same time as venetoclax. So glasdegib plus LDAC yielded an 8.8 months overall survival compared with LDAC alone for 4.9 months. I think as you start to get into the nitty-gritty of things, now that we have a lot of options in AML, there was a difference in response based on cytogenetic risk stratification.

Patients with good and intermediate risk exhibited a more significant response, a better improvement in overall survival, 12 months compared with 4.8 months in the LDAC arm [HR, 0.427; 80% CI, 0.300-0.609; P = .0008]. Patients with high-risk MDS and AML had a blunted response. Median OS for glasdegib was 4.7 months compared with 4.9 months for LDAC arm [HR, 0.633; 80% CI, 0.430-0.934; P = .0640].

The response data for glasdegib were not as impressive compared with venetoclax responses that I discussed earlier. The investigators reported a CR rate of 17% and CRi rate of 6.5%. They reported an overall response rate of 26% compared with 5% for LDAC alone. And I think that this is a good point to consider as we look at new agents for AML. Its always a point of conversation, especially in these older, more frail patients. How do we consider both a survival benefit and CR rate in a more elderly patient? If they could live with their disease and be relatively symptom-free, how important is that CR?

For this patient, is HMA still a consideration?

The patient was treated with venetoclax in combination with azacitidine. If the investigators followed the clinical trial regimen, this patient would not have been eligible for HMA.

But I think certainly, like many, depending on the patient and how much HMA they have received, we might consider still using HMA in combination with venetoclax as a salvage therapy. And the patient does have a response with a remission and is transfusion independent after 45 days on treatment.

Would you consider a bone marrow transplant for him?

We tend to use bone marrow transplants quite frequently, I think, because in our experience, almost all of these patients have very serious cytopenias eventually. We have found it helpful to do bone marrow transplants to document a response. However, if you have a patient who is doing great [and] the counts are beautiful, then maybe not.

Maybe that bone marrow transplant is not as helpful if the patient has had a full hematologic response. In general, our experience has been that many of these patients, especially like this patient were discussing, theyre likely to end up cytopenic at the end of their first cycle of treatment. And so then were left really scratching our heads. Are they cytopenic because there is disease in the bone marrow? Or are they cytopenic because theyre aplastic?

References:

1. NCCN Clinical Practice Guidelines in Oncology. Acute myeloid leukemia, version 3.2020. NCCN. Accessed July 29, 2020. https://bit.ly/3jSYRs3

2. Lancet JE, Uy Gl, Cortes JE, et al. Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML. J Clin Oncol. 2016;34(suppl 15):7000. doi: 10.1200/JCO.2016.34.15_suppl.7000

3. Kolitz JE, Strickland SA, Cortes JE, et al. Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia. Leuk Lymphoma. 2020;61(3):631-640. doi:10.1080/10428194.2019.1688320

4. Dinardo CD, Pratz KW, Potluri J, et al. Durable response with venetoclax in combination with decitabine or azacitidine in elderly patients with acute myeloid leukemia (AML). J Clin Oncol. 2018;36(suppl 15):7010. doi:10.1200/JCO.2018.36.15_suppl.7010

5. DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133(1):7-17. doi:10.1182/blood-2018-08-868752

6. Cortes JE, Heidel FH, Hellmann A, et al. Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemiaor high-risk m yelodysplastic syndrome. Leukemia. 2019;33(2):379-389. doi:10.1038/s41375-018-0312-9

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McCloskey Explores Merits of Targeted Treatments and HMAs in MDS - Targeted Oncology

Allogeneic Stem Cell Therapy Market Study for 2020 to 2026 Providing Information on Key Players, Growth Drivers and Industry Challenges|Escape…

Allogeneic Stem Cell Therapy Market Los Angeles, United State- The global Allogeneic Stem Cell Therapy market is carefully researched in the report while largely concentrating on top players and their business tactics, geographical expansion, market segments, competitive landscape, manufacturing, and pricing and cost structures. Each section of the research study is specially prepared to explore key aspects of the global Allogeneic Stem Cell Therapy market. For instance, the market dynamics section digs deep into the drivers, restraints, trends, and opportunities of the global Allogeneic Stem Cell Therapy Market. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the global Allogeneic Stem Cell Therapy market. We have also focused on SWOT, PESTLE, and Porters Five Forces analyses of the global Allogeneic Stem Cell Therapy market.

Leading players of the global Allogeneic Stem Cell Therapy market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the global Allogeneic Stem Cell Therapy market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the global Allogeneic Stem Cell Therapy market. It also provides useful recommendations for new as well as established players of the global Allogeneic Stem Cell Therapy market.

Get PDF template of this report: https://www.qyresearch.com/sample-form/form/2043756/global-and-china-allogeneic-stem-cell-therapy-market

Allogeneic Stem Cell Therapy Market Leading Players

, Escape Therapeutics, Inc., Lonza Group Ltd., Osiris Therapeutics (Smith & Nephew), NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Anterogen, MolMed S.p.A., Takeda (TiGenix)

Allogeneic Stem Cell Therapy Segmentation by Product

, Adult Stem Cell Therapy, Human Embryonic Stem Cell Therapy, Induced Pluripotent Stem Cell Therapy, Others Allogeneic Stem Cell Therapy

Allogeneic Stem Cell Therapy Segmentation by Application

Musculoskeletal Disorder, Wounds & Injuries, Cardiovascular Diseases, Others

Report Objectives

Analyzing the size of the global Allogeneic Stem Cell Therapy market on the basis of value and volume.

Accurately calculating the market shares, consumption, and other vital factors of different segments of the global Allogeneic Stem Cell Therapy market.

Exploring the key dynamics of the global Allogeneic Stem Cell Therapy market.

Highlighting important trends of the global Allogeneic Stem Cell Therapy market in terms of production, revenue, and sales.

Deeply profiling top players of the global Allogeneic Stem Cell Therapy market and showing how they compete in the industry.

Studying manufacturing processes and costs, product pricing, and various trends related to them.

Showing the performance of different regions and countries in the global Allogeneic Stem Cell Therapy market.

Forecasting the market size and share of all segments, regions, and the global market.

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Table of Contents.

1 Report Overview 1.1 Study Scope 1.2 Market Analysis by Type 1.2.1 Global Allogeneic Stem Cell Therapy Market Size Growth Rate by Type: 2020 VS 2026 1.2.2 Adult Stem Cell Therapy 1.2.3 Human Embryonic Stem Cell Therapy 1.2.4 Induced Pluripotent Stem Cell Therapy 1.2.5 Others 1.3 Market by Application 1.3.1 Global Allogeneic Stem Cell Therapy Market Share by Application: 2020 VS 2026 1.3.2 Musculoskeletal Disorder 1.3.3 Wounds & Injuries 1.3.4 Cardiovascular Diseases 1.3.5 Others 1.4 Study Objectives 1.5 Years Considered 2 Global Growth Trends 2.1 Global Allogeneic Stem Cell Therapy Market Perspective (2015-2026) 2.2 Global Allogeneic Stem Cell Therapy Growth Trends by Regions 2.2.1 Allogeneic Stem Cell Therapy Market Size by Regions: 2015 VS 2020 VS 2026 2.2.2 Allogeneic Stem Cell Therapy Historic Market Share by Regions (2015-2020) 2.2.3 Allogeneic Stem Cell Therapy Forecasted Market Size by Regions (2021-2026) 2.3 Industry Trends and Growth Strategy 2.3.1 Market Trends 2.3.2 Market Drivers 2.3.3 Market Challenges 2.3.4 Market Restraints 3 Competition Landscape by Key Players 3.1 Global Top Allogeneic Stem Cell Therapy Players by Market Size 3.1.1 Global Top Allogeneic Stem Cell Therapy Players by Revenue (2015-2020) 3.1.2 Global Allogeneic Stem Cell Therapy Revenue Market Share by Players (2015-2020) 3.2 Global Allogeneic Stem Cell Therapy Market Share by Company Type (Tier 1, Tier 2 and Tier 3) 3.3 Players Covered: Ranking by Allogeneic Stem Cell Therapy Revenue 3.4 Global Allogeneic Stem Cell Therapy Market Concentration Ratio 3.4.1 Global Allogeneic Stem Cell Therapy Market Concentration Ratio (CR5 and HHI) 3.4.2 Global Top 10 and Top 5 Companies by Allogeneic Stem Cell Therapy Revenue in 2019 3.5 Key Players Allogeneic Stem Cell Therapy Area Served 3.6 Key Players Allogeneic Stem Cell Therapy Product Solution and Service 3.7 Date of Enter into Allogeneic Stem Cell Therapy Market 3.8 Mergers & Acquisitions, Expansion Plans 4 Allogeneic Stem Cell Therapy Breakdown Data by Type (2015-2026) 4.1 Global Allogeneic Stem Cell Therapy Historic Market Size by Type (2015-2020) 4.2 Global Allogeneic Stem Cell Therapy Forecasted Market Size by Type (2021-2026) 5 Allogeneic Stem Cell Therapy Breakdown Data by Application (2015-2026) 5.1 Global Allogeneic Stem Cell Therapy Historic Market Size by Application (2015-2020) 5.2 Global Allogeneic Stem Cell Therapy Forecasted Market Size by Application (2021-2026) 6 North America 6.1 North America Allogeneic Stem Cell Therapy Market Size (2015-2026) 6.2 North America Allogeneic Stem Cell Therapy Market Size by Type (2015-2020) 6.3 North America Allogeneic Stem Cell Therapy Market Size by Application (2015-2020) 6.4 North America Allogeneic Stem Cell Therapy Market Size by Country (2015-2020) 6.4.1 United States 6.4.2 Canada 7 Europe 7.1 Europe Allogeneic Stem Cell Therapy Market Size (2015-2026) 7.2 Europe Allogeneic Stem Cell Therapy Market Size by Type (2015-2020) 7.3 Europe Allogeneic Stem Cell Therapy Market Size by Application (2015-2020) 7.4 Europe Allogeneic Stem Cell Therapy Market Size by Country (2015-2020) 7.4.1 Germany 7.4.2 France 7.4.3 U.K. 7.4.4 Italy 7.4.5 Russia 7.4.6 Nordic 7.4.7 Rest of Europe 8 China 8.1 China Allogeneic Stem Cell Therapy Market Size (2015-2026) 8.2 China Allogeneic Stem Cell Therapy Market Size by Type (2015-2020) 8.3 China Allogeneic Stem Cell Therapy Market Size by Application (2015-2020) 8.4 China Allogeneic Stem Cell Therapy Market Size by Region (2015-2020) 8.4.1 China 8.4.2 Japan 8.4.3 South Korea 8.4.4 Southeast Asia 8.4.5 India 8.4.6 Australia 8.4.7 Rest of Asia-Pacific 9 Japan 9.1 Japan Allogeneic Stem Cell Therapy Market Size (2015-2026) 9.2 Japan Allogeneic Stem Cell Therapy Market Size by Type (2015-2020) 9.3 Japan Allogeneic Stem Cell Therapy Market Size by Application (2015-2020) 9.4 Japan Allogeneic Stem Cell Therapy Market Size by Country (2015-2020) 9.4.1 Mexico 9.4.2 Brazil 10 South Korea 10.1 South Korea Allogeneic Stem Cell Therapy Market Size (2015-2026) 10.2 South Korea Allogeneic Stem Cell Therapy Market Size by Type (2015-2020) 10.3 South Korea Allogeneic Stem Cell Therapy Market Size by Application (2015-2020) 10.4 South Korea Allogeneic Stem Cell Therapy Market Size by Country (2015-2020) 10.4.1 Turkey 10.4.2 Saudi Arabia 10.4.3 UAE 10.4.4 Rest of Middle East & Africa 11 Key Players Profiles 11.1 Escape Therapeutics, Inc. 11.1.1 Escape Therapeutics, Inc. Company Details 11.1.2 Escape Therapeutics, Inc. Business Overview 11.1.3 Escape Therapeutics, Inc. Allogeneic Stem Cell Therapy Introduction 11.1.4 Escape Therapeutics, Inc. Revenue in Allogeneic Stem Cell Therapy Business (2015-2020)) 11.1.5 Escape Therapeutics, Inc. Recent Development 11.2 Lonza Group Ltd. 11.2.1 Lonza Group Ltd. Company Details 11.2.2 Lonza Group Ltd. Business Overview 11.2.3 Lonza Group Ltd. Allogeneic Stem Cell Therapy Introduction 11.2.4 Lonza Group Ltd. Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.2.5 Lonza Group Ltd. Recent Development 11.3 Osiris Therapeutics (Smith & Nephew) 11.3.1 Osiris Therapeutics (Smith & Nephew) Company Details 11.3.2 Osiris Therapeutics (Smith & Nephew) Business Overview 11.3.3 Osiris Therapeutics (Smith & Nephew) Allogeneic Stem Cell Therapy Introduction 11.3.4 Osiris Therapeutics (Smith & Nephew) Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.3.5 Osiris Therapeutics (Smith & Nephew) Recent Development 11.4 NuVasive 11.4.1 NuVasive Company Details 11.4.2 NuVasive Business Overview 11.4.3 NuVasive Allogeneic Stem Cell Therapy Introduction 11.4.4 NuVasive Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.4.5 NuVasive Recent Development 11.5 Chiesi Pharmaceuticals 11.5.1 Chiesi Pharmaceuticals Company Details 11.5.2 Chiesi Pharmaceuticals Business Overview 11.5.3 Chiesi Pharmaceuticals Allogeneic Stem Cell Therapy Introduction 11.5.4 Chiesi Pharmaceuticals Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.5.5 Chiesi Pharmaceuticals Recent Development 11.6 JCR Pharmaceutical 11.6.1 JCR Pharmaceutical Company Details 11.6.2 JCR Pharmaceutical Business Overview 11.6.3 JCR Pharmaceutical Allogeneic Stem Cell Therapy Introduction 11.6.4 JCR Pharmaceutical Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.6.5 JCR Pharmaceutical Recent Development 11.7 Pharmicell 11.7.1 Pharmicell Company Details 11.7.2 Pharmicell Business Overview 11.7.3 Pharmicell Allogeneic Stem Cell Therapy Introduction 11.7.4 Pharmicell Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.7.5 Pharmicell Recent Development 11.8 Anterogen 11.8.1 Anterogen Company Details 11.8.2 Anterogen Business Overview 11.8.3 Anterogen Allogeneic Stem Cell Therapy Introduction 11.8.4 Anterogen Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.8.5 Anterogen Recent Development 11.9 MolMed S.p.A. 11.9.1 MolMed S.p.A. Company Details 11.9.2 MolMed S.p.A. Business Overview 11.9.3 MolMed S.p.A. Allogeneic Stem Cell Therapy Introduction 11.9.4 MolMed S.p.A. Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.9.5 MolMed S.p.A. Recent Development 11.10 Takeda (TiGenix) 11.10.1 Takeda (TiGenix) Company Details 11.10.2 Takeda (TiGenix) Business Overview 11.10.3 Takeda (TiGenix) Allogeneic Stem Cell Therapy Introduction 11.10.4 Takeda (TiGenix) Revenue in Allogeneic Stem Cell Therapy Business (2015-2020) 11.10.5 Takeda (TiGenix) Recent Development 12 Analysts Viewpoints/Conclusions 13 Appendix 13.1 Research Methodology 13.1.1 Methodology/Research Approach 13.1.2 Data Source 13.2 Disclaimer 13.3 Author Details

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Allogeneic Stem Cell Therapy Market Study for 2020 to 2026 Providing Information on Key Players, Growth Drivers and Industry Challenges|Escape...

NantKwest and ImmunityBio Sign Collaboration Agreement for Joint Development, Manufacturing, Marketing, and Commercialization of COVID-19 Vaccine and…

EL SEGUNDO, Calif. & CULVER CITY, Calif.--(BUSINESS WIRE)--NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately held immunotherapy company, today announced the signing of a definitive agreement to jointly develop, manufacture, market, and commercialize therapeutics and vaccines for combating the COVID-19 pandemic.

Under the terms of the definitive agreement, the two companies agree to share equally the costs incurred after August 21, 2020 of development, manufacturing, marketing, and commercialization of the products each is developing related to COVID-19. Should a product be commercialized successfully, the companies have agreed to a 60-40 percentage split of net profits, with the larger share going to the company that developed the product. The agreement also details the structure of shared governance of the joint collaboration.

The two product candidates currently in development under the agreement are a mesenchymal stem cell (MSC) therapeutic from NantKwest, whose goal is to reduce the time a critically ill patient spends on a ventilator; and a COVID-19 vaccine product from ImmunityBio, which is anticipated to soon enter into a phase I clinical trial.

The severity and global nature of the COVID-19 pandemic demands that researchers move rapidly and have the resources necessary to develop ways to fight this deadly virus, said Patrick Soon-Shiong, Chairman and CEO of NantKwest and ImmunityBio. The agreement strengthens the efforts of both companies on behalf of patients, while also ensuring each company will earn a fair share of the returns of a successful product.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer or other critical illnesses, including COVID-19. Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwests NK cells and MSC as well as other therapeutics and manufacturing challenges.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

About ImmunityBio

ImmunityBio, Inc. is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious disease. The companys immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term immunological memory. This novel approach is designed to eliminate the need for high-dose chemotherapy, improve upon the outcomes of current CAR T-cell therapies, and extend beyond checkpoint inhibitors.

ImmunityBios platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation vaccine technologies.

ImmunityBios lead cytokine infusion protein, a novel interleukin-15 (IL-15) superagonist complex (Anktiva), has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). Other indications currently at registration-stage trials include BCG-unresponsive papillary bladder cancer, first and second line lung cancer, triple-negative breast cancer, metastatic pancreatic cancer, recurrent glioblastoma, and soft tissue sarcoma in combination with the companys synthetic immune modulator (Aldoxorubicin).

ImmunityBio is also developing therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2 with its second-generation human adenovirus (hAd5) vaccine platform.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of various diseases, including, but not limited to the novel coronavirus and cancer. Risks and uncertainties related to this endeavor include, but are not limited to, the companys beliefs regarding the success, cost, and timing of its development activities and clinical trials.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

Excerpt from:
NantKwest and ImmunityBio Sign Collaboration Agreement for Joint Development, Manufacturing, Marketing, and Commercialization of COVID-19 Vaccine and...

Could gene therapy stem the damage of Parkinson’s? – Health24

It may be possible to protect Parkinson's patients' brains from further damage by turning off a "master regulator" gene, researchers report.

"One of the biggest challenges in treating Parkinson's, other than the lack of therapies that impede disease progression, is that the disease has already laid waste to significant portions of the brain by the time it is diagnosed," said researcher Viviane Labrie, an associate professor at the Van Andel Institute, in Grand Rapids, Michigan.

"If we can find a way to protect critical brain cells from Parkinson's-related damage early on, we could potentially delay or even prevent symptom onset," she suggested in an institute news release.

Deadly for brain cells

Labrie and her colleagues compared the brains of Parkinson's patients and people without the neurodegenerative disease and found that a master regulator gene called TET2 was overactive in the brains of those with Parkinson's. That resulted in a heightened immune response and reactivation of the cell cycle.

While restarting the cell cycle is normal for many types of cells, it's deadly for brain cells, the study authors explained.

The researchers also found that reducing TET2 activity in mouse brains protects brain cells from inflammatory damage and the resulting neurodegeneration seen in Parkinson's disease patients.

These and other findings suggest that lowering TET2 activity could provide a new way to preserve brain cells in Parkinson's patients, according to the authors of the study published in the journal Nature Neuroscience.

A complex disease

For example, reducing TET2 activity might be used after a patient has a major inflammatory event, such as an infection, to relieve residual inflammation without interfering with its normal, healthy role in the body.

"Parkinson's is a complex disease with a range of triggers. Temporarily reducing TET2 activity could be one way to interfere with multiple contributors to the disease, especially inflammatory events, and protect the brain from loss of dopamine-producing cells," Labrie said.

"More work is needed before a TET2-based intervention can be developed, but it is a new and a promising avenue that we already are exploring," she concluded.

Image credit: iStock

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Could gene therapy stem the damage of Parkinson's? - Health24

Global Animal Stem Cell Therapy Market is Expected to reach CAGR of 38.3% During 2020-2024 – Bulletin Line

Global Marketers presents an updated and Latest Study on Animal Stem Cell Therapy Market 2020-2024. This report comprises a detailed study of the market covering its future predictions by the past year as a reference for the period between 2020 and 2024 as the forecast period. The report breakdowns major segments and highlights wider level geographies. The report bridges a perfect balance of both qualitative and quantitative information of the Animal Stem Cell Therapy Market. This report also offers an all-inclusive study of the future trends and developments of the market.

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Global Animal Stem Cell Therapy Market is Expected to reach CAGR of 38.3% During 2020-2024 - Bulletin Line

Stem Cell Therapy Market: Beating Growth Expectations- MEDIPOST, BIOTIME, BrainStorm Cell Therapeutics, Caladrius, JCR Pharmaceuticals, AlloSource -…

The Stem Cell Therapy market, study now available at Ample Market Research, is a detailed sketch of the business sphere in terms of current and future trends driving the profit matrix. The report also indicates a point-wise outline of market share, market size, industry partakers, and regional landscape along with statistics, diagrams, & charts elucidating various noteworthy parameters of the industry landscape.

The Stem Cell Therapy Market research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data and statistically-supported and industry-validated market data and projections with a suitable set of assumptions and methodology. It provides analysis and information by categories such as market segments, regions, and product types and distribution channels.

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Top Key Players Present in Global Auger Drilling Market Are: MEDIPOST, BIOTIME, BrainStorm Cell Therapeutics, Caladrius, JCR Pharmaceuticals, AlloSource, NuVasive, Holostem Terapie Avanzate, RTI Surgical, Advanced Cell Technology, Pharmicell, Osiris Therapeutics, Anterogen

Different leading key players have been profiled in this research report to get a clear idea of successful strategies carried out by top-level companies. On the basis of geographical segmentation, the global Stem Cell Therapy Market has been fragmented across several regions such as North America (Covered in Chapter 7 and 14), United States, Canada, Mexico, Europe (Covered in Chapter 8 and 14), Germany, UK, France, Italy, Spain, Russia. This Market research report highlights those leading players who are planning to expand opportunities in the global market.

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Chapter 5 Market Segmentation by Application

Chapter 6 Market Segmentation by Region

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Chapter 9 Conclusion

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Stem Cell Therapy Market: Beating Growth Expectations- MEDIPOST, BIOTIME, BrainStorm Cell Therapeutics, Caladrius, JCR Pharmaceuticals, AlloSource -...

Eimear’s Wish Gin helping Belfast family pay tribute to daughter and raise awareness for Stem Cell Donation – Belfast Live

When Eimear Smyth passed away, her family promised her that they'd raise awareness for stem cell donation in the most fun way possible.

The West Belfast woman was 22 when she was diagnosed with Hodgkins Lymphoma and died just three years later after complications from a Donor Stem Cell transplant.

Today, Eimear's family and friends continue to raise awareness for stem cell donation, organ donation and blood cancer as part of Eimear's Wish.

From fundraisers to pink glazed donuts, everything the Smyth's have done in memory of Eimear has been fun, so they decided to take things up a notch and create a Gin brand named after the woman who taught them so much in life and death.

Speaking to Belfast Live, Eimear's dad Sean said the Gin has proved popular from across Ireland and beyond.

"Eimear's Wish Gin has taken a life of its own, people are really interested. We are getting requests from all over, and then when people try it they're asking for me. And the Wolf and Whistle in West Belfast are actually going to run a cocktail for us too.

"Our Eimear loved lemon and strawberry sherbet so they have agreed to run a pink lemon sherbet cocktail in memory of Eimear, and it launched on September 4 so we are looking forward to that.

"Everything we want to do, and have done in the past has been fun. See standing and shaking a bucket saying 'give me your money,' we don't want to do that. And we don't want to make it sad, because there is enough sadness in the world.

Eimear just loved dancing, and her social life. She loved coffee and donuts and now and again would take a wee Gin. She wasn't a big drinker but she would love having a Gin named after her.

"And the idea is to create a legacy for Eimear and to get people talking about stem cell donation, blood cancer and organ donation."

Eimear's Wish are asking for a 30 charitable donation which will be divided equally between Action Cancer, Cancer Fund for Children and Anthony Nolan Stem Cell - and in turn you'll get a bottle of Eimear's Gin.

All three charitable groups have helped Eimear and the Smyth family throughout their darkest days.

"Action Cancer was very, very good to us. Cancer Fund for Children looked out for Eimear and Anthony Nolan are helping to raise that awareness," said Sean.

"There are not enough people in Northern Ireland on the stem cell list, especially from the BAME community. If you are a white European, there's a 70% chance that you will find a match, but if you are from the Black, Asian, Minority Ethnic community that chance is 20% because your tissue is more difficult to match. So we need more people from those backgrounds to join.

"Before Eimear, I didn't know much about stem cell donation, I didn't know that stem cell and bone marrow was the same thing. I always thought it was two separate things.

"Our problem was that Eimear was only 22. She had just graduated and was taking the year out to get the money to go on to do a PGCE to become a teacher. She didn't smoke and rarely drank, she had a good healthy lifestyle. No cancer in my side of the family or Eimear's mummy's side. If that can happen to Eimear, it can happen to anyone, and that was really frightening.

"Awareness if one part of it, but the other part is to get better facilities, more age appropriate facilities for our young people who are going through this."

Throughout her illness, Eimear was treated in the City Hospital.

Hailing the medical care his daughter received, Sean says he would like to see more "age appropriate settings" for young adults for treatment.

"Eimear couldn't open the window to feel air on her skin when she was there. The TVs don't work. There's nowhere for relatives to sleep and there is one small fridge for 24 people. The facilities are from 1986. It is a horrible place to die.

"People have got to understand that we do not have age appropriate care for teenagers and young adults. They're sitting beside a 70-year-old man who is also ill, it's not fair on either patient to be in that situation.

"Eimear lived in Leeds and was treated in St James' Hospital and the unit she was in was brilliant. It was for patients aged 17-24. You walk in and there's a fully stocked kitchen for parents. The wards are a four people maximum. The far end of the ward is a youth club, it has snooker tables, jukeboxes, all the games consoles.

"The outpatients come for their chemo and their friends come with them for company. It is brilliant but we have nothing here. If we hadn't been in England we wouldn't have known the difference, we would have just thought it was the norm.

"The environment isn't nice at all. These are our kids. They're told those three words 'you've got cancer' and that is heartbreaking. The only thing I want is for the young people to be able to look at something other than beige colour walls. They deserve better.

"Nothing will ever bring my daughter back, but if we can make it a bit easy for another family or child, then we'll do that - it was Eimear's Wish."

For more information on how to donate, how to order a bottle or Eimear's Wish Gin or to stock it in your premises CLICK HERE.

You can register as a stem cell donor with the Anthony Nolan Trust or DKMS.

Link:
Eimear's Wish Gin helping Belfast family pay tribute to daughter and raise awareness for Stem Cell Donation - Belfast Live

What voters need to know about Californias ballot propositions – OCRegister

Lets make some new rules for California gig workers!

Lets get back to the old rules when it comes to using race and ethnicity to admit or reject students at California universities!

Lets tweak the living heck out of the current rules that define the mother of all California tax laws, the 1978 version of Prop 13!

These are just a few of the dozen proposals that California voters will approve or reject in the Nov. 3 general election. Others would lower the voting age by a few months in primary elections, expand consumer privacy protection, change cash bail and give cities more clout regarding rent control, among other things.

Its a lot to consider. And given that mail-in ballots go out in early October, it might be time to look hard at what each proposition is about.

Heres a primer:

Vote yes for this and state taxpayers will be on the hook for $5.5 billion in bonds aimed at reviving the California Institute for Regenerative Medicine (CIRM), a program created in 2004 to boost stem cell research.

SCNG editorial boards endorsement on Proposition 14

A vote against it would save money, but it might kill CIRM. The 16-year-old program ran out of its initial funding last year and it hasnt taken on new research since last summer, according to the state.

Stem cells, if youre wondering, are used in medical research on everything from nerve disorders and blindness to tooth decay.

Prop. 14 would create some rules for how CIRM spends money going forward. And at least $1.5 billion would be used for research on age-related issues such as Alzheimers, Parkinsons, and dementia, among other things.

Supporters say keeping CIRM alive could be key to future medical breakthroughs.

Opponents note that federal limits on spending for stem-cell research the reason why California voters were asked to fund CIRM in the first place no longer exist.

A yes vote here would represent a big change in California, essentially creating two distinct tracks (split roll) one for most commercial buildings and another for residential dwellings in our famed Proposition 13 property tax code.

SCNG editorial boards endorsement on Proposition 15

Under Prop. 15, the tax rate on most commercial and industrial properties would be based on the buildings market value, not its purchase price. Exceptions would be made for buildings used in agriculture and for buildings owned by individuals or companies with less than $3 million in other assets. Overall, the state estimates it would generate up to $12.5 billion a year in new taxes from the owners of commercial properties.

A no vote would leave Californias Prop. 13 tax rules intact. All structures in California commercial, industrial, residential would continue to be taxed as they are now, with annual tax hikes jumping no more than the rate of inflation or 2%, whichever is lower.

Supporters say Prop. 15 would close a loophole that often benefits big businesses at the expense of small businesses, and that the money raised would help offset revenue losses expected as a result of the coronavirus pandemic.

Opponents say it will hurt job creation and make California a less attractive place to do business. Others argue its effectively a tax hike at a time when businesses are already struggling.

A yes vote on Prop. 16 would make it legal to consider race and gender, among other things, as potentially favorable factors when it comes to making decisions about public employment, public education and public contracting.

Technically, Prop. 16 is a constitutional amendment to repeal Prop. 209, a 1996 law approved by voters that ended the use of affirmative action in California.

Legally, Prop. 16 would reinstate the federal version of affirmative action, which allows for race-based and sex-based preferences in the interest of promoting diversity as long as quotas and other strict mandates arent part of any acceptance formula.

Supporters argue that Prop. 16 would be a step to helping undo the results of long-standing race and gender discrimination that have been key to economic and social inequality. They note that most states already follow federal guidelines on affirmative action.

Opponents counter that by saying any law that allows preferences essentially legalizes racism and sexism. Some also argue that Asian students who currently qualify for University of California schools at roughly twice the rate of other race and ethnic groups could be unfairly affected by Prop 16.

A yes vote for Prop. 17 would make it legal for people to vote while on parole for a felony conviction.

SCNG editorial boards endorsement on Propositions 17 and 18

Right now, in California, felons cant vote until after theyve served both their prison sentence and any parole. And, just so were clear, Prop. 17 does not propose letting felons vote while in prison.

Supporters say parolees are in the process of rejoining public life and that voting, much like working and paying taxes, is part of being a member of your community.

Opponents say voting is a right that should not be restored until a felon has completed all of his or her punishment, including parole.

A yes vote would make it legal for people who will turn 18 in time for the general election to vote, even while still 17, in that years primary.

SCNG editorial boards endorsement on Propositions 17 and 18

Supporters say the move would boost the number of engaged, informed voters in any election cycle.

Opponents note that people under 18 are children. They also argue that because almost all 17-year-olds still live with their parents their votes might be unfairly influenced.

This complicated, grab bag of a proposal would allow older homeowners (ages 55 and up), as well as disabled people and people whove lost properties in a natural disaster, to take some of their property tax base with them when they sell a home and buy a new one.

SCNG editorial boards endorsement on Proposition 19

It also would make it harder to keep a low property tax rate while transferring properties between generations.

And, finally, most of the new money generated by these changes would be used to help pay for firefighting.

The details matter. Specifically, Prop. 19 would:

Bump up from one to three the number of times an older individual can move while keeping their original property tax rate.

Limit a familys ability to pass on a low tax rate to properties used as principal residences, and limit the low tax rate to the first $1 million in equity. Right now, a parent or grandparent can bestow their low tax rate while passing on a rental home or vacation property. That feature would be eliminated under Prop. 19.

Supporters say the law will make it easier for older people to move. And supporters in the real estate industry like the idea that it could promote buying and selling of homes.

Opponents say Prop. 19 will result in less money for schools and other public entities funded by property taxes in California. A similar idea without the firefighting fund failed in 2018. It also was backed by the home-selling industry.

A yes vote for Prop. 20 would add to the states list of wobbler crimes, violations that currently are misdemeanors but, under this proposal, could be charged as felonies in some circumstances. Were talking about crimes like organized petty theft, credit card scams and stealing a firearm, among others.

Prop. 20 also would create stiffer penalties for people who violate terms of their parole three times and make it tougher for people convicted of certain crimes including domestic violence to be considered for early parole. And, finally, Prop. 20 would require that DNA samples be taken from people convicted of some misdemeanors.

Supporters say some crimes now considered minor have a serious effect on victims and, because of that, warrant tougher penalties.

Opponents argue that harsh sentencing guidelines havent prevented crime and that an opposite trend in recent years has made California safer.

A yes vote on Prop. 21 would let cities write new rent control laws for older housing (15 years and older) or expand any rent control rules they already have on the books.

SCNG editorial boards endorsement on Proposition 21

The proposal carves out an exception for single-family homes owned by landlords with no more than two properties. And, while Prop. 21 would wipe out the Costa-Hawkins Rental Housing Act (Costa-Hawkins) of 1995, it would not change the 7% rent hike limit set by state lawmakers last year.

Supporters say this could make a dent in homelessness and housing unaffordability, two problems that have reached crisis levels in California.

Opponents say rent control doesnt work as intended and that other rules including limits on building restrictions would better address the problems targeted by Prop. 21.

Do you work for an app like Lyft or Uber? If so, a yes vote on Prop. 22 would make you an independent contractor, same as you were before the passage of AB 5, which took effect last September.

SCNG editorial boards endorsement on Proposition 22

Under Prop. 22, rideshare and delivery companies that depend on armies of gig workers, would not have to pay standard wage and hour restrictions, though they would have to provide an earnings floor and some money to purchase health insurance, among other things.

A no vote on Prop. 22 means existing law including AB 5 will apply to all employers.

Its important to note that Prop. 22 is about people who use their own cars and cell phones as keys to their trade. Independent musicians, writers and others who work independently but dont use tech platforms as a tool would remain covered by controversial AB 5.

Supporters say Prop. 22 will keep rideshare and delivery services inexpensive.

Opponents say the employers who depend on gig workers have abused that relationship and are simply refusing to pay minimum wage, something all other businesses must do. Others also point out that Prop. 22 does nothing to address the problems created by AB 5, which has led to less work for some traditional independent contractors and financial problems for their employers.

A yes vote on Prop. 23 would mean at least one physician would have to be on site at an operating dialysis clinic. It also would require clinics to report on infections and get health department approval to close. And it would prohibit clinics from discriminating against patients based on how they pay for the clinics services.

SCNG editorial boards endorsement on Proposition 23

Supporters say the new rules would make it safer for kidney dialysis patients.

Opponents say the new rules would add burdensome costs.

A yes vote on Prop. 24 would expand and add to Californias two-year-old law on consumer data privacy and its reuse. Consumers could prohibit companies from sharing their personal information for any reason and shorten the period companies currently are given to fix the problem.

Prop. 24 also would create a Privacy Protection Agency to enforce the new rules.

Some other details in Prop. 24:

Companies would be limited when collecting data on any consumer younger than 16, and would need permission from a parent or guardianto collect data on consumers younger than 13.

Companies would have to correct any inaccurate information upon request.

Supporters say Prop. 24 adds teeth to the privacy law that California voters approved in 2018.

Opponents say Prop. 24 doesnt go far enough, and it would serve as a giveaway to the biggest social media companies.

Two years ago, state legislators passed a law (SB 10) to end cash bail in California. A yes vote on Prop. 25 would keep that law in place, replacing cash bail with a risk assessment system that would let people wait for trial at home based on a variety of factors.

A no vote on Prop. 25 would maintain the cash bail system, letting people stay or leave jail while awaiting trial based largely on their ability to pay.

Supporters argue that cash bail is, by definition, an unequal application of justice favoring people with money. They also note that Prop. 25 is a referendum sponsored by the cash bail industry and that its success would pave the way for other industries to simply spend their way around laws they dont like.

Opponents say the risk assessment system that would replace cash bail is biased and, because it uses computer modeling, is potentially inflexible.

Read the original:
What voters need to know about Californias ballot propositions - OCRegister

The Science of Survival: Evolving Research in Advanced Non-Small Cell Lung Cancer – Reuters

Despite significant progress in treating cancer in recent years, the need for further improvements has persisted particularly for some of the most challenging forms of the disease, such as lung cancer. Lung cancer is one of the most common cancers, and is the leading cause of cancer death in both men and women.

The majority of lung cancer cases are non-small cell lung cancer (NSCLC), a complex disease that can affect each patient differently. Most cases of NSCLC are not diagnosed until the disease is advanced meaning it has metastasized or spread which can make it more challenging to treat.

The impact of lung cancer, and advanced NSCLC in particular, continues to be felt across our communities, explained Andrea Ferris, president and chairman of LUNGevity Foundation. While every persons experience with the disease is unique, many patients hope they can retain a sense of normalcy in their lives and are seeking more treatment options that offer a chance at a longer life.

Research Driving New Progress for Certain Patients

Researchers have accelerated their pursuit of new and differentiated approaches that address this critical unmet need, focusing on options that may offer patients a chance at a longer life. One area of research that has shown potential is combining treatments, such as immunotherapies, for certain patients with previously untreated advanced disease.

Hossein Borghaei, D.O., chief of thoracic medical oncology at Fox Chase Cancer Center in Philadelphia explains, Progress in treating advanced lung cancer has led to more options for patients with newly diagnosed advanced NSCLC. Some of the most recent developments in the field of immunotherapy are particularly exciting.

One example is the U.S. Food and Drug Administrations approval of the first and only dual immunotherapy approach for newly diagnosed patients. Opdivo (nivolumab) is a prescription medicine used in combination with Yervoy (ipilimumab) for adults with advanced stage NSCLC that has spread to other parts of your body (metastatic) and tests positive for PD-L1 and do not have an abnormal EGFR or ALK gene.

Opdivo can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Additional serious side effects of Yervoy alone include: nerve problems that can lead to paralysis; eye problems; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Please see Important Facts about side effects for Opdivo and Yervoy below.

Opdivo and Yervoy work with your immune system to help fight cancer in two ways. Yervoy stimulates the kind of cells that help fight cancer, while Opdivo may help these cells to find and fight the cancer cells again. While doing so, Opdivo and Yervoy can also affect healthy cells. These problems can sometimes become serious or life threatening and can lead to death. These problems may happen anytime during treatment or even after treatment has ended. Some of these problems may happen more often when Opdivo is used in combination with Yervoy.

Clinical Trial Findings: A Chance to Live Longer

Opdivo + Yervoy was studied in a clinical trial and compared to platinum-based chemotherapy among certain patients with previously untreated, advanced NSCLC that tested positive for PD-L1.

In the trial, 396 patients received Opdivo + Yervoy and 397 patients received platinum-based chemotherapy. Patients who were treated with Opdivo + Yervoy lived longer than those treated with platinum-based chemotherapy:

In the trial, 396 patients received Opdivo + Yervoy and 397 patients received platinum-based chemotherapy. Patients who were treated with Opdivo + Yervoy lived longer than those treated with platinum-based chemotherapy:

An additional analysis showed:

The data supporting this dual immunotherapy approach are encouraging, particularly as one third of the patients who responded to treatment with Opdivo + Yervoy were still alive at three years, said Dr. Borghaei. Further, Opdivo + Yervoy offers a non-chemotherapy option, which can be important to some patients.

The most common side effects of Opdivo, when used in combination with Yervoy, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness. Please see Important Facts about side effects for Opdivo and Yervoy below.

Evolving Outlooks and Adapting Support for Patients

Facing a lung cancer diagnosis and beginning treatment can be life-altering in many ways and todays unique environment as a result of the coronavirus has brought about additional considerations for patients, caregivers and the broader healthcare community, with telemedicine and other forms of remote support playing an increasingly vital role.

Patients should know there are resources available and ways to stay connected, even during times when maintaining physical distance from others is important, said Ferris. We have transformed many of our patient support and education offerings into virtual formats, which we are updating frequently to provide the most recent information and reach and connect as many people as possible.

Dr. Borghaei also urges patients to reach out to their doctor or care team to learn about and take advantage of available remote support offerings. Advances in cancer research are still happening every day, with Opdivo + Yervoy being one example. Its as important as ever that people diagnosed with lung cancer speak with their doctor to fully understand their treatment options. While how we deliver care might look different now in some ways, our commitment to helping patients live longer hasnt changed.

To learn more about Opdivo + Yervoy, please visit http://www.Opdivo.com.

INDICATION

OPDIVO (nivolumab) is a prescription medicine used in combination with YERVOY (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

ImportantSafetyInformationforOPDIVO(nivolumab) + YERVOY (ipilimumab)

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.

Serious side effects may include: Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath. Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness. Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; feeling less hungry than usual; and decreased energy. Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; feeling cold; constipation; voice gets deeper; and excessive thirst or lots of urine. Kidney problems, including nephritis and kidney failure.Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite. Skin problems.Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes. Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck. Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; and chest pain.

Additional serious side effects observed during a separate study of YERVOY alone include: Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet. Eye problems.Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness.

Get medical help immediatelyif you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may also need to delay or completely stop your treatment.

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including: Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out. Graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), may be severe, and can lead to death, if you receive YERVOY either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.

Pregnancy and Nursing: Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO. Females who are able to become pregnant should use an effective method of birth control duringtreatmentand for at least 5 months after the last dose. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy. Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869. Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 5 months after the last dose.

Tell your healthcare provider about: Your health problems or concerns if you: have immune system problems such as autoimmune disease, Crohns disease, ulcerative colitis, lupus, or sarcoidosis; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical conditions. All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection;headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatchor call 1-800-FDA-1088.

Please see U.S. Full Prescribing Information and Medication Guide forOPDIVO and YERVOY.

2020 Bristol-Myers Squibb Company.

OPDIVO and YERVOY are registered trademarks of Bristol-Myers Squibb Company.

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