Bristol Myers claims success in study testing earlier CAR-T use in multiple myeloma

Dive Brief:

• Bristol Myers Squibb and partner 2Seventy bio see potential for earlier use of their multiple myeloma treatment Abecma after reporting clinical trial results that showed the CAR-T cell therapy outperformed standard drug regimens.
• Treatment with Abecma held patients’ cancer in check for significantly longer than did those standard drugs, the companies said in a Wednesday statement. The trial enrolled patients who had been treated with between two to four previous lines of care, and whose cancer was resistant to their most recent prior therapy.
• Bristol Myers and 2Seventy bio did not share any specific data on Abecma’s efficacy or rates of side effects, indicating that full results would be presented at an upcoming medical meeting. The companies also plan to discuss the outcome with regulators. In the U.S., Abecma is approved for multiple myeloma that’s relapsed from or become resistant to at least four prior treatment regimens.

Dive Insight:

Cancer cell therapies like Abecma, as well as others that came before it in leukemia and lymphoma, were proven first in patients who had run out of treatment options, usually through clinical trials that lacked a control arm.

Bristol Myers and 2Seventy bio’s study, dubbed KarMMa-3, is designed to push use of the therapy earlier and, according to the companies, is the first randomized trial of a CAR-T therapy in multiple myeloma to read out results.

Compared to standard regimens using drugs like Darzalex, Pomalyst and Revlimid, Abecma led to significantly longer progression-free survival, which measures the length of time patients go without their disease progressing, or dying.

Abecma also led to more treatment responses, although the companies did not specify whether the difference between study arms was statistically significant. Follow-up is continuing to assess whether Abecma helped study participants live longer than those who received other drugs.

While full details are being reserved for disclosure at a future meeting, the data could help Bristol Myers and 2Seventy bio ask the Food and Drug Administration and other health agencies for an expanded approval. The companies jointly develop and market Abecma in the U.S., sharing profits and costs.

Launched last year, sales of Abecma have begun to ramp up, although the companies have struggled to match demand with adequate supply. Between April and June, Abecma earned $72 million in U.S. sales and the companies expect full year revenue to climb up to between $250 million to $300 million.

Both companies have said they’re working to expand production capacity, constraints on which have forced doctors to make difficult decisions on which patients should receive treatment, according to reporting by STAT.

In particular, 2Seventy said Wednesday that it was spending more than expected on the viral vectors the companies use to genetically engineer the T cells that are at the heart of their therapy.

The two companies are facing new competition as well. The FDA approved a rival multiple myeloma CAR-T from Johnson & Johnson and Legend Biotech in February. That treatment, known as Carvykti, is also being studied in earlier disease settings.

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