StemCell Therapy

Updated data for a second anti-BCMA therapy, idecabtagene vicleucel (ide-cel) from Bristol Myers Squibb/bluebird bio, will be presented, including health-related quality of life results from the KarMMA study in patients with heavily pretreated R/R multiple myeloma. FDA has assigned a March 27, 2021, target date for action on this therapy.

Also anticipated are results from the APOLLO study in relapsed multiple myeloma, which will show that adding daratumumab and hyaluronidase-finj, called Darzalex Faspro by Janssen, to pomalidomide and dexamethasone reduces the risk of disease progression or death by 37% compared with pomalidomide and dexamethasone alone.

Notably, this phase 3 study involves subcutaneous administration of daratumumab, which offers significantly reduced treatment time and burden for patients. Janssen has submitted results from APOLLO to FDA and the European regulators.

The subcutaneous formulation of daratumumab offers patients and physicians a 3- to 5-minute administration experience and the potential to reduce systemic administration-related reactions compared to intravenous administration of daratumumab, said Meletios A. Dimopoulos, MD, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, who is the studys principal investigator.

The REACH3 study, a phase 3 randomized study of ruxolitinib (Jakavi) vs best-available-therapy, will have important implications in chronic graft-vs-host-disease (GvHD). This condition occurs when new T cells from a stem cell transplant identify the patients cells as foreign and attack them, creating reactions from rashes to gastrointestinal issues to harm to the liver.

Results involving transplant in myelodysplatic syndromes (MDS) could have important implications for reimbursement. Corey Cutler, MD, MPH, FRCPC, of Dana-Farber Cancer Institute will present results that show transplantation of hematopoietic stem cells from compatible donors nearly doubled the survival rate of patients aged 50 to 75 years.

Even though transplant is frequently used in younger patients, it has not been widely used among older patients. Lack of Medicare coverage is a major barrier, Cutler explained. This study adds to a growing body of evidence that suggests its time to revisit the reimbursement question.

Asked his thoughts on whether CMS might change its policy, Cutler said, I cant speak for the agency, but I will tell you there are several studies that do suggest it should be covered.We are, of course, reaching out to CMS.

Fridays press briefing ahead of the opening of ASH highlighted the results for MDS and daratumumab and others that are expected to be practice changing. To know that older patients do well with transplant is a really important message, said Lisa Hicks, MD, MSc, a hematologist from St. Michaels Hospital in Canada, who moderated the briefing.

Ian Flinn, MD, of Tennessee Oncology, who is an author on several studies being presented at ASH involving venetoclax (Venclexta) and Brutons tyrosine kinase (BTK) inhibitors in chronic lymphocytic leukemia, said he was interested to see the results of the CAPTIVATE trial.

He said that right now, venetoclax is a fixed-duration therapy. Now, we need to figure out whether thats a good idea or not, Flinn said. CAPTIVATE will help clinicians understand whether they should keep patients on venetoclax plus ibrutinib after they have reached the point of minimal residual disease.

The ASH meeting will also highlight research examining disparities in care, as well as the effects of COVID-19 on outcomes. On Saturday, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), will discuss the latest information on COVID-19 and its impact on hematologic conditions in a fireside chat with ASH President Stephanie J. Lee, MD, MPH.

This week, President-elect Joe Biden announced that Fauci will be a chief medical adviser, in addition to retaining his longtime role at NIAID during the new administration.

Maggie L. Shaw contributed to this report.

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