Bristol Myers Squibb’s drug Abecma is the first FDA-approved CAR T-cell therapy for multiple myeloma, but like its peers, the treatment’s risk of serious side effects has limited its use in the most advanced cases. The pharma giant now has data from a pivotal study showing Abecma exceeds the standard of care, Preliminary results This could support the promotion of cell therapy as an early treatment approach.
Abecma met its primary goal of showing a statistically significant improvement in progression-free survival, a measure of how long a patient survives without the cancer getting worse, BMS said Wednesday. Specific details of the results for this endpoint have not been released, but the company said they came from a pre-specified interim analysis conducted by an independent review committee.
The preliminary results were also positive for one of the trial’s secondary endpoints. Abecma improved overall response rates compared to standard treatment, BMS said. There are not enough data to assess overall survival, another secondary objective. BMS said it will work with 2seventy bio to evaluate all data, which will be presented at an upcoming medical meeting. They also plan to discuss the results with regulators.
FDA’s Approval of Abecma in 2021 covers treatment of patients who have received at least four earlier treatments. Access to earlier lines of treatment could significantly expand drug use. In a research note to investors on Wednesday, William Blair analyst Matt Phipps said an estimated 3,000 multiple myeloma patients in the U.S. receive fifth-line treatment each year. At the fourth-line level, the number of patients is about 6,000. An estimated 12,000 to 13,000 patients with multiple myeloma receive third-line therapy. Phipps added that the number of patients in each treatment line in the pivotal study will be key in gauging Abecma’s potential expansion opportunities.
Gaining FDA approval as an early-stage multiple myeloma treatment would give Abecma an edge over Carvykti, a rival CAR T product from Johnson & Johnson and Legendary Biotech. Carvykti was approved earlier this year as a fifth-line treatmentSame as Abecma.
Abecma’s Phase 3 trial targeted 381 patients with advanced multiple myeloma. Eligibility covers those whose cancer has received two to four lines of treatment and has not responded to the last treatment regimen.
BMS turns to biotech startup to develop cell therapy for IBD
In other BMS cell therapy news, the pharma giant has started Research collaboration with GentiBioa biotech startup developing treatments for autoimmune and inflammatory diseases.
in Boston GentiBio focuses on a type of immune cell called regulatory T cells or Treg. Some autoimmune diseases are associated with excessive immune system activity that promotes inflammation. Tregs work by suppressing inflammation. The focus of the BMS/GentiBio consortium is inflammatory bowel disease. Under the terms of the deal announced Wednesday, GentiBio will use its technology to develop engineered Tregs for multiple targets. BMS has the right to develop and advance up to three of these into clinical testing.
GentiBio received an upfront payment to begin a multi-year alliance. Specific details about the payment were not disclosed, but BMS said development and sales milestone payments could reach $1.9 billion. GentiBio will also receive royalties from the sale of alliance-approved products.
Photo by Bristol-Myers Squibb
