On September 6, 2021,JW Therapeutics announced that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (relma-cel) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, and has released the drug registration certificate. Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and the sixth approved CAR-T product globally.
About Relmacabtagene Autoleucel Injection (trade name: Carteyva®)
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company).
This approval is based on the results of a single-arm, multi-center, pivotal study (RELIANCE study) to evaluate the efficacy and safety of relma-cel in patients with r/r LBCL in China.RELIANCE study results show that relma-cel demonstrated high rates of durable disease response and low rates of CAR-T associated toxicities, and may provide a best-in-class CAR-T therapy profile.
At the 24th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO),JW Therapeutics announced updated 1-year follow-up result of relmacabtagene autoleucel injection (relma-cel) for the treatment of r/r LBCL.Results include:
Relma-cel showed durable responses and long-term survival benefit; the Best Overall Response Rate (ORR) was 77.6%, the Best Complete Response Rate (CRR) was 51.7% and 1-year Overall Survival (OS) was 76.8% with a median follow-up of 17.9 months;
Relma-cel was generally well-tolerated with a safety profile including a low severe Cytokine Release Syndrome (≥grade 3) of 5.1% and a low severe neurotoxicity rate (≥grade 3) of 3.4%, and no new safety signals with a median of 17.9 months of follow-up;
Long-term follow-up of the RELIANCE study have confirmed the durability of response and long-term OS with relma-cel treatment, which also was associated with low rates of CAR-T-associated toxicities.
LBCL is the most common and aggressive type of non-Hodgkin lymphoma and most patients relapse after initial therapies with limited treatment options with standard therapies and a median survival of approximately 6 months.These long-term follow-up data reported from the RELIANCE study have confirmed the durability of responses after relma-cel treatment, representing a potentially important treatment option for these patients that appears to offer clear hope of longer survival.
At present, there are many other CAR-T clinical trials in China, and they are looking for patients. For consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
2.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20210903084004127.html
3.https://www.sciencedirect.com/science/article/pii/S0006497118704138
4.https://www.jwtherapeutics.com/en/media/press-release/jw-therapeutics-announces-updated-1-year-follow-up-result-of-relmacabtagene-autoleucel-injection-at-the-24th-annual-meeting-of-the-chinese-society-of-clinical-oncology-csco-1/
Post time: Nov-15-2024