Another Car-T scare might be hard to brush off

The extremely rare occurrence of Car-positive lymphomas in Car-T patients has limited impact on oncology companies, but the same likely can’t be said about a separate development that happened during the Christmas lull. On 21 December the FDA added to the prescribing information for Johnson & Johnson/Legend’s Carvykti a boxed warning about risk of secondary myeloid malignancies. The updated label cites five cases of myelodysplastic syndrome, three of AML, and two of MDS followed by AML, among 97 patients in the Cartitude-1 study. This might cause alarm given that the implied rate of such malignancies is 10% – much higher than the 19 T-cell lymphoma cases reportedly seen among some 34,400 patients worldwide in the earlier scare. At the JP Morgan healthcare conference Legend confirmed that the FDA had identified the risk when reviewing a request to add PFS data from Cartitude-1 to Carvykti’s label. Jefferies analysts reckon other Car-T products will see similar warnings “as the FDA sees [this] as a cell therapy class effect"; Bristol Myers Squibb/2seventy’s Abecma currently doesn’t carry one. While doctors might be willing to take the risk in patients without other options, it could be a different matter in earlier-line and relatively indolent settings.

At risk? Anti-BCMA Car-T therapies in selected early multiple myeloma settings

Source: OncologyPipeline.