Yescarta® Is First CAR T-cell Therapy to Report Five-Year Survival Data From Pivotal Study Showing Durable Long-Term Survival in Patients With Refractory Large B-cell Lymphoma

December 11 2021 - SANTA MONICA, Calif. - Kite, a Gilead Company (Nasdaq: GILD), today announced five-year follow-up data from the pivotal ZUMA-1 trial of Yescarta^® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma (LBCL). Among all patients treated with Yescarta, the five-year overall survival (OS) rate was 42.6%. Among patients who had a complete response (CR), the five-year OS rate was 64.4%  and median survival time has yet to be reached. Among treated patients alive at five years, 92% have received no additional treatment since their one-time infusion of Yescarta, suggestive of a cure for these patients. The data were presented today at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition.

Related to LLS TAP's investment into the Zuma-1 trial prior to Kite being acquired by Gilead, the long-term survival data was presented.

Since the four-year analysis, there has been one death in the study, which was due to secondary malignancy from prior chemotherapy and/or conditioning chemotherapy-related myelodysplastic syndrome (MDS) while the patient was in complete remission for LBCL. There have been no new safety signals reported, including no Yescarta-related secondary malignancies.

The presenters also reported an exploratory analysis of ZUMA-1 data showing a high degree of correlation between long-term OS and event-free survival (EFS) status, which potentially supports the use of one-year and two-year EFS as surrogate endpoints for long-term OS in relapsed/refractory LBCL.

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