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Gilead and Arcellx Immagine the future

While Arcellx and Gilead gun for a 2026 launch of their anti-BCMA Car-T therapy anitocabtagene autoleucel in fourth-line multiple myeloma they have revealed plans to target earlier lines of the disease. This is relevant given the recent US approvals of two similarly acting Car-Ts, Johnson & Johnson/Legend’s Carvykti and Bristol Myers Squibb/2seventy Bio’s Abecma, in early multiple myeloma. Anito-cel’s phase 3 Immagine-3 study is to start in the second half, and will target patients who have received one to three prior lines of therapy, the companies said last night. As promised earlier, all patients will have to have received Genmab/J&J’s anti-CD38 MAb Darzalex, a fast-emerging front-line treatment standard. As such anito-cel will be taking aim at Carvykti’s recently approved use, with the added stipulation of Darzalex failure; Abecma’s Karmma-3 trial also mandated Darzalex failure, but that was technically a later-line trial, in third to fourth-line disease. Carvykti’s Cartitude-4 study therefore provides a benchmark of sorts for Immagine-3, though the bigger questions remain whether control arm patients can or will have to receive Carvykti, and whether regulators remain comfortable with PFS as an approvable endpoint given the failure of Abecma and Carvykti alike to show an OS benefit.


Anti-BCMA Car-T therapy in early multiple myeloma

            Abecma            Carvykti            Anito-cel

Setting3rd-5th line2nd-4th line2nd-4th line
Prior ASCT66%85%?
PI refractory100%45%?
IMID refractory100%100%100%
CD38 MAb refractory100%24%100%
PFS vs std therapy13.3mth vs 4.4mth (HR=0.49)NE vs 12.0mth (HR=0.41)Will be the primary endpoint
OS?Not significant, 56% crossover from control to AbecmaAt 34% maturity there were more Carvykti deaths vs control over first 10mthsWill be a secondary endpoint

Source: prescribing info, NEJM & company statement.


Molecular Drug Targets