Abecma risks falling further behind Carvykti

Both approved BCMA Car-T therapies, Johnson & Johnson/Legend’s Carvykti and Bristol Myers Squibb/2seventy’s Abecma, are having a tough time on the market, but the latter’s problems might be the bigger of the two. While J&J’s issue is that manufacturing is failing to meet demand, Abecma is being hit by "competitive dynamics", with data backing it in multiple myeloma salvage settings being worse than for Carvykti. As of yesterday Bristol faces a fresh problem: the FDA is to convene an adcom over Abecma’s earlier use (backed by Karmma-3), meaning that a 16 December PDUFA date for its filing will not be met. At best this spells a delay for Abecma, and at worst suggests doubts in the regulator’s mind; in relapsed multiple myeloma Carvykti’s Cartitude-4 trial showed a 74% reduction in risk of progression – substantially better than the 51% managed by Abcema in the slightly later-line Karmma-3 study. Notably, on a recent earnings call Legend said it wasn’t expecting an adcom to be convened for a filing covering Cartitude-4’s second to fourth-line setting. A regulatory verdict for the Cartitude-4 indication is due by a 5 April 2024 PDUFA date.

Cross-trial comparison for anti-BCMA Car-T therapies

Notes: *approved use; PVd=Pomalyst, Velcade + dexamethasone; DPd=Darzalex, Pomalyst + dexamethasone; VRd=Velcade, Revlimid + dexamethasone; Rd=Revlimid + dexamethasone; DVRd=Darzalex, Velcade, Revlimid + dexamethasone; IRd=Ninlaro, Revlimid + dexamethasone; Kd=Kyprolis + dexamethasone; EPd=Empliciti, Pomalyst + dexamethasone; ASCT=autologous stem cell transplant; this table was updated to add the Karmma-9 study. Source: OncologyPipeline, prescribing info & clinicaltrials.gov.