Gilead CAR-T’s indolent lymphoma data impresses at ASCO. How to position it is

Drugmaker Gilead Sciences has its sights set on a second approval for its CAR-T cell therapy following the release of data from its clinical trial in slow-growing non-Hodgkin’s lymphomas at a large cancer conference.

The Foster City, California-based company announced the presentation of data from the Phase I/II ZUMA-5 study of Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory indolent NHL, including follicular lymphoma (FL) and marginal zone lymphoma (MZL), at the American Society of Clinical Oncology’s annual conference. The CAR-T has been on the market for nearly three years for diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL, in which it competes with Novartis’ Kymriah (tisagenlecleucel).

Shares of Gilead were mostly flat on the Nasdaq Friday following the announcement.

Among 96 patients evaluable for efficacy – including 80 with FL and 16 with MZL – 93% responded, with 80% having a complete response. The median duration of response was 20.8 months, with a median follow-up of 15.3 months. Median progression-free survival was 23.5 months, while the median overall survival was not reached. The safety analysis included 140 patients, with 8% experiencing severe or worse cytokine release syndrome and 17% experiencing neurological toxicities of similar severity. One FL patient died from complications related to CRS, while another died from causes unrelated to Yescarta.

“Most patients responded, with an over 90% response rate and an 80% complete response rate, which is quite impressive,” said Dr. Caron Jacobson, medical director of the cell therapy program at Dana-Farber Cancer Institute and presenter of the study results, in a phone interview.

Meanwhile, Ibrahim Elhoussieny, VP and head of global medical affairs at Gilead subsidiary Kite Pharma, said the efficacy data compare favorably with those of existing treatment options like Bristol-Myers Squibb’s Revlimid (lenalidomide), AbbVie’s Venclexta…

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