Benzinga | Dec 11, 2021 09:17AM EST

Gilead's Kite Announced 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; Said 42.6% of Study Patients Alive at Five Years Following a Single Infusion of Yescarta

Kite, a Gilead Company (NASDAQ:GILD), today announced five-year follow-up data from the pivotal ZUMA-1 trial of Yescarta(r) (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% (95% CI, 32.8 51.9). Among patients who had a complete response (CR), the five-year OS rate was 64.4% (95% CI, 50.8 75.1) 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 (Abstract #1764).

"At five years, these data demonstrate impressive and durable survival benefit with axicabtagene ciloleucel in patients with refractory LBCL," said Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School. "Nearly half of patients in the ZUMA-1 trial are still alive at five years a group that previously had an average life expectancy of only six months. These results are a truly transformative shift in the standard of care for this disease."

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.

"Five-year survival in any cancer patient is a significant milestone and the point in which we dare to consider the word cure,'" said Frank Neumann, MD, PhD, Kite's Global Head of Clinical Development. "We set out to develop a treatment with curative intent, and Yescarta has delivered on this promise by transforming the outlook for LBCL for some of the sickest patients who have exhausted other treatment options."

Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.