Yescarta Demonstrates 74% Complete Response Rate as First-Line Therapy in High-Risk Large B-Cell Lymphoma

December 09, 2020 /Bio ValleyBIOON/ -- Kite Pharma, the cell therapy subsidiary of Gilead Sciences, recently presented interim analysis results from the Phase 2 ZUMA-12 study of its CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel) at the 62nd Annual Meeting of the American Society of Hematology (ASH). This is a multicenter, single-arm, open-label Phase 2 study evaluating Yescarta as first-line treatment for adult patients with high-risk large B-cell lymphoma (LBCL).

Data show that, following a single infusion of Yescarta and with at least one month of follow-up, among 27 evaluable patients with high-risk LBCL,85% of patients achieved disease response (overall response rate [ORR] = 85%), and 74% achieved complete response (complete response rate [CR] = 74%).With a median follow-up of 9.3 months, 70% of patients with evaluable response remained in ongoing response at the data cutoff. After a median follow-up of 9.5 months, the median progression-free survival (PFS), median overall survival (OS), and median duration of response (DOR) had not been reached.

Among all safety-evaluable patients who received any dose of Yescarta and had at least one month of follow-up (n=32), 9% and 25% of patients experienced grade 3 or higher cytokine release syndrome (CRS) and neurologic events (NE), respectively. No grade 5 CRS or NE occurred. There was one case of a grade 5 adverse event caused by COVID-19.

Dr. Sattva S. Neelapu, Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, stated: “Although in newDiagnosisMature standard treatment regimens are already established for large B-cell lymphoma (LBCL), but patients with high-risk disease remain underserved by existing therapies. Only half of these patients achieve long-term remission with standard first-line treatment, highlighting a critical need for therapeutic approaches that can improve outcomes for a greater proportion of patients. The early results from the ZUMA-12 trial are highly encouraging, confirming the potential of CAR-T cell therapy in the earlier treatment of high-risk patients.”

Ken Takeshita, M.D., Global Head of Clinical Development at Kite, stated, “Yescarta has already provided four-year survival data in patients with third-line refractory large B-cell lymphoma (LBCL), and we are now excited about the outcomes of early treatment observed in the ZUMA-12 study. As the first positive results for CAR-T cell therapy as a first-line treatment for LBCL, these data represent a significant step forward. We remain committed to bringing the therapeutic benefits of Yescarta to a broader population of patients with high-risk LBCL.”

Yescarta was approved in the United States in October 2017FDAApproved as the first CAR-T cell therapy for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), with the specific indication for the treatment of adult patients with relapsed or refractory LBCL who have received two or more prior lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL), and DLBCL arising from follicular lymphoma (FL) (i.e., transformed FL, TFL). Yescarta is not indicated for the treatment of primary central nervous system lymphoma.

In China, Yescarta (axicabtagene ciloleucel injection [proposed], code FKC876) is being developed by Fosun Kite Biotechnology Co., Ltd. (FOSUN Kite), a joint venture established by Shanghai Fosun Pharmaceutical Group and Kite Pharma. In mid-March this year, Fosun Kite announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) had included the New Drug Application (NDA) for axicabtagene ciloleucel injection (proposed), a CAR-T cell therapy product, in its priority review program. The therapy is indicated for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

Yikaililunsai Injection (code name FKC876) is a CD19-targeted autologous CAR-T cell therapy product that Fosun Kite has licensed from Kite Pharma for the Yescarta (axicabtagene ciloleucel) technology and is authorized for localized production in China.

This product is the first CAR-T cell therapy product that Fosun Kite has advanced toward commercialization in China, and it is also the first CAR-T cell therapy product for which the National Medical Products Administration (NMPA) has formally accepted a marketing application. As a completely newTumorAs a treatment option, FKC876 can bring new hope and opportunities for Chinese patients with relapsed or refractory large B-cell lymphoma who have received two or more lines of systemic therapy. (Bioon.com)

Original Source: Yescarta® Shows Positive Results as a First-Line Treatment for Patients With High-Risk Large B-cell Lymphoma