RE:RE:CAR-T update March 12, 2024 - Ahead of a high-stakes FDA meeting to review CAR-T data in multiple myeloma, Legend Biotech CEO Ying Huang, Ph.D., laid out some of his expectations about the event.
For one, the Legend CEO expects that the advisory committee meeting will largely focus on overall survival efficacy results, rather than the FDA’s CAR-T safety probe that’s playing out in parallel to the company’s label expansion application for Johnson & Johnson-partnered Carvykti.
The FDA’s oncologic drugs advisory committee will convene this Friday to review Legend and J&J’s high-stakes bid to move their Carvykti into second-line treatment of multiple myeloma.
Despite the boxed warning issue, the meeting will focus on Carvykti’s overall survival benefit rather than any specific toxicities, Legend Biotech's Huang said Monday.
Experts will also discuss Bristol Myers Squibb’s submission for rival drug Abecma in the third-line setting. The two applications will be discussed separately in morning and afternoon sessions.
For its part, BMS will need to defend Abecma, which showed no life extension benefit—and instead a negative 1% trend in overall survival—compared with standard combinations in the KarMMa-3 study in patients who had previously tried two to four prior lines of treatment.
BMS has attributed the lack of overall survival showing to a high, 56% crossover rate in which patients in the control arm went on to receive Abecma after disease progression. However, the FDA’s oncology department appears unwilling to tolerate any negative trend in overall survival, even if trial crossover is to blame.
By comparison, Carvykti’s CARTITUDE-4 does not allow for patient crossovers. This may raise some eyebrows given the FDA’s support for crossover trial designs, as well as possible questions about whether the lack of crossover actually gave Carvykti its survival edge.
https://www.fiercepharma.com/pharma/legend-ceo-offers-preview-high-profile-fda-adcomm-jj-partnered-carvykti