JW Therapeutics (HKEx: 2126), an independent innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, presented the latest clinical response on Carteyva? (relmacabtagene autoleucel injection) in adults with relapsed/refractory mantle cell lymphoma (r/r MCL) in China at the 65th American Society of Hematology (ASH) Annual Meeting.
Update on the?Safety and Efficacy of Relmacabtagene Autoleucel (relma-cel) in Adults with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) in China (abstract number: 3024)
In this phase II single-arm open-label study in China, participants with r/r MCL who had been treated with a CD20-targeting antibody, anthracycline, or bendamustine or BTKi were included. After lymphodepleting chemotherapy, participants received relma-cel (100×106 CAR T cells). The primary endpoint of the study was the overall response rate (ORR) at the third month and totally 59 participants with evaluable efficacy were planned to be enrolled.
As of the data cut-off of June 30, 2023, a total of 56 participants received relma-cel infusion. Of 42 efficacy evaluable participants, relma-cel demonstrated remarkable clinical responses achieving high rates of complete response rate (CRR) and overall response rate (ORR) (3 months best ORR 78.57%, 3 months best CRR 66.67% ).
The safety assessment showed that, in 56 participants who received Carteyva?, the incidence of severe (grade≥3) cytokine release syndrome (CRS) was 5.36%, the incidence of severe (grade≥3) neurotoxicity (NT) was 7.14%, and the incidence of severe (grade≥3) infection was 26.79%.This study is ongoing and further results will be presented.
Mark J. Gilbert, MD, Chief Medical Officer of JW Therapeutics, noted: We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of participants with r/r MCL have achieved complete remission after treatment with relma-cel, and the overall safety data demonstrated that the treatment was generally well tolerate. Carteyva? is expected to become the first commercial CAR-T cell product for the treatment of r/r MCL in China.”
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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). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.
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About JW Therapeutics
JW Therapeutics (HKEx: 2126) is an independent, innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Co-founded by Juno Therapeutics (a Bristol Myers Squibb company) and WuXi AppTec in 2016, JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a top world-class platform for technology and product development in cell immunotherapy, as well as a promising product pipeline covering both hematologic malignancies and solid tumors, to bring the hope of a cure for Chinese and global patients, and to lead the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit .