Legend investors hope EU endorsement is good omen

An EU recommendation for Johnson & Johnson/Legend’s BCMA-targeting Car-T Carvykti last Friday in early lines of multiple myeloma was seen as good news for the groups’ US efforts. Legend’s stock climbed 7% the same day after the endorsement from the EMA’s Committee for Medicinal Products for Human Use (CHMP), for Carvykti as a second-line therapy. The previous indication was for fourth-line or later disease; the CHMP also recommended that Carvykti’s conditional go-ahead be converted to standard approval. The EMA is generally seen as being stricter than the FDA, which has convened an adcom on 15 March to discuss both Carvykti and Bristol Myers Squibb/2seventy’s Abecma; the makers of the latter as are also gunning for earlier use. Carvykti’s chances look better: that product’s Cartitude-4 trial found signs of improving survival, albeit in an immature interim analysis, while Abecma failed to show a survival benefit in the Karmma-3 trial. However, to confuse matters further, the CHMP granted Abecma a positive opinion in January for third-line or later multiple myeloma. In a couple of weeks it should become clear whether the FDA will take a similar stance as its EU counterpart.