Yescarta provides sustained survival benefit vs current therapies in FL

Positive follow-up results from the pivotal ZUMA-5 trial of Yescarta (axicabtagene ciloleucel) - the first and only CAR T-cell therapy approved in the USA in patients with relapsed or refractory indolent follicular lymphoma (FL) - were presented over the weekend at the 26th Annual Meeting of the European Hematology Association (EHA 2021) now taking place virtually, by Gilead Sciences’ (Nasdaq: GILD) subsidiary Kite.

At a minimum follow-up of 18 months, 94% of patients had achieved a response, and secondary endpoints of median progression-free survival (PFS) and overall survival (OS) were not yet reached. In a weighted analysis comparing ZUMA-5 patients with a minimum of 18 months follow-up with those observed in SCHOLAR-5, an external control cohort, Yescarta demonstrated superior OS and PFS over currently available treatments.

Yescarta received accelerated approval from the US Food and Drug Administration for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy in March 2021. However, so far, the CAR-T cell therapy has generated disappointing sales, recording full-year 2020 revenue of just $563 million.