On September 6, 2021, the China NMPA has approved the New Drug Application (NDA) for CD19 CAR-T cell therapy Carteyva (relmacabtagene autoleucel).
This anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell therapy is designed for adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. Carteyva is notable as the first CAR-T product approved as a Category 1 biologics product in China and the sixth approved globally.
Developed independently by JW Therapeutics using a CAR T cell process platform from Juno Therapeutics (a Bristol Myers Squibb company), Carteyva addresses the specific needs of the Chinese market. It is currently the only CAR-T product in China recognized in the National Significant New Drug Development Program and has received priority review and breakthrough therapy designations for follicular lymphoma. Over 100 patients have received Carteyva in clinical trials, making it the most studied anti-CD19 CAR-T therapy in China.
The approval follows the results of the RELIANCE study, a pivotal, multi-center, single-arm trial evaluating the efficacy and safety of Carteyva in r/r LBCL patients. The study demonstrated high rates of durable disease response and low levels of CAR-T-associated toxicities, positioning Carteyva as a potential best-in-class therapy.
According to data presented at the 2020 American Society of Hematology (ASH) Annual Meeting, the best Overall Response Rate (ORR) at 6 months reached 75.9%, and the best Complete Response Rate (CRR) was as high as 51.7%. The median time to first complete response (CR) was only 0.95 months, highlighting the strong and rapid efficacy of Relmacabtagene Autoleucel.
From the perspective of long-term outcomes, the 1-year Overall Survival (OS) rate was 77%. The median Progression-Free Survival (PFS) and Duration of Response (DOR) were 7.0 months (95% CI, 5.5–NA) and 8.0 months (95% CI, 5.09–NA), respectively, indicating that Relmacabtagene Autoleucel delivers both rapid and durable responses.
Professor Zhu Jun, lead investigator of the RELIANCE study and Chief of Internal Medicine and Lymphoma Departments at Peking University Cancer Hospital, expressed pride in the study’s high-quality completion. He noted, “Based on its outstanding efficacy and safety, I believe Carteyva will offer healthcare professionals in China a valuable treatment option and hope for long-term remission and potentially a cure for lymphoma patients.”
Edward Hu, Vice Chairman and Global Chief Investment Officer at WuXi AppTec, congratulated JW Therapeutics on the approval, highlighting the importance of cell and gene therapy in cancer treatment. He expressed confidence in JW Therapeutics’ future contributions to cell immunotherapy in China.
Lynelle Hoch, Senior Vice President and Global Cell Therapy Franchise Lead at Bristol Myers Squibb, praised the collaboration with JW Therapeutics in advancing cell therapy science, viewing the approval as a significant milestone for patients in China.
James Li, Co-founder, Chairman, and CEO of JW Therapeutics, thanked the patients and investigators involved in the Carteyva studies and acknowledged the Chinese regulators for their science-driven approach in approving this significant therapy. He reaffirmed JW Therapeutics’ commitment to innovative technology in serving Chinese patients.
