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J&J/Legend’s Carvykti Data Show Earlier-Line Efficacy As Commercial Headwinds Remain

 
• By Alaric DeArment

The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.

J&J/Legend announced positive results from the Phase III CARTITUDE-4 study • Source: Shutterstock

Johnson & Johnson’s Janssen Pharmaceutical Cos. and Legend Biotech Corp. have unblinded their Phase III study of the BCMA-targeted CAR-T therapy Carvykti (ciltacabtagene autoleucel) in patients with second- to fourth-line multiple myeloma after the trial met its primary endpoint. But even if the data give Carvykti a leg up over its main competitor, 2seventy Bio, Inc./Bristol Myers Squibb Company’s Abecma (idecabtagene vicleucel), ongoing production and logistical issues may make the rollout to a larger patient population particularly challenging.

Without disclosing detailed data, J&J and Legend said 27 January that the trial, CARTITUDE-4, met its primary endpoint of showing...

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