CAR-T therapies are typically reserved for heavily pretreated patients because of their novelty and side effects. Now, Bristol Myers Squibb is trumpeting a first-in-class trial win as it tries to move Abecma up in the treatment sequence for multiple myeloma.
Abecma significantly prolonged the time to tumor progression or death compared with standard combination therapies in multiple myeloma patients who’d failed two to four prior lines of therapy, BMS said Tuesday.
The latest readout, from an interim analysis of the KarMMa-3 study, makes Abecma the first CAR-T cell therapy to beat standard treatments in a randomized, head-to-head trial in relapsed and refractory multiple myeloma, BMS noted.
The positive results could yield an FDA approval for Abecma as a third-line myeloma treatment. It’s currently only allowed in the fifth line. BMS and its partner 2seventy bio, a spinout of bluebird bio, said they will evaluate the full data and discuss the findings with drug regulators.
Abecma is in a tight race with Johnson & Johnson and Legend Biotech’s rival BCMA-targeted CAR-T therapy, Carvykti. Both are relegated to the fifth line based on tumor response data, and both are targeting earlier treatment settings, which have bigger patient pools.
Abecma got its approval nearly a year ahead of Carvykti and is now the first to report a randomized trial win. But Carvykti may still wind up one step ahead in terms of treatment sequence.
J&J and Legend’s phase 3 Cartitude-4 trial is pitting Carvykti against standard therapy in patients who’ve tried one to three prior lines of therapy, one line earlier than Abecma’s current KarMMa-3 study. That study started in June 2020 and is ongoing. Abecma’s own second-line endeavor is still in phase 2 in the form of the KarMMa-2 trial.
Meanwhile, BMS has been busy expanding its CAR-T cell therapy production capacity amid rising demand for Abecma and CD19-directed Breyanzi. The latter drug just followed Gilead Sciences’ Yescarta into second-line large B-cell lymphoma with a broader FDA approval.
Thanks to efforts to expand capacity, Abecma’s sales reached $89 million in the second quarter, up 36% over the first three months of 2022. Despite the increase, demand for Abecma continues to outpace supply, BMS CFO David Elkins said during a recent investor call.
“We are focused on further expanding capacity, including additional manufacturing sites in the future,” Elkins said.
By comparison, J&J and Legend are taking a phased approach to Carvykti’s launch, which started in April. The companies are gradually bringing Carvykti treatment centers online, instead of rolling out the drug to all areas at once, to ensure ample supply.
“One of the challenges we hear from our KOLs and our providers is, ‘I need certainty, I need to know if I’m going to have a slot this month and next month … because I have lines of people I’m trying to prepare for therapy,'” Mike Hirschmann, Legend’s U.S. commercial lead, said at this year’s J.P. Morgan Healthcare Conference.