SHANGHAI, CHINA, December 13, 2021 - JW Therapeutics (HKEx: 2126), an independent innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, presented the primary clinical response on Carteyva® (relmacabtagene autoleucel injection) in adults with relapsed/refractory follicular lymphoma (r/r FL) in China at the 63rd American Society of Hematology (ASH) Annual Meeting.
As of the data cut-off of September 10, 2021, 28 patients were treated with Carteyva® with at least three months of follow-up.
Of 27 efficacy evaluable patients, as assessed by the investigator, best overall response rate (ORR) was 100% (27/27) and best complete response rate (CRR) was 92.6% (25/27). With a median follow-up of 8.84 months, the median duration of response (DOR), progression-free survival (PFS) and overall survival (OS) were not reached.
In 28 patients who received Carteyva®, any grade and severe (grade≥3) cytokine release syndrome (CRS) were 42.9% and 0%, respectively, and any grade and severe (grade≥3) neurotoxicity (NT) were 17.9% and 3.6%, respectively.
Dr. Mark J. Gilbert, Chief Medical Officer of JW Therapeutics, commented: “Most patients with r/r FL remain incurable and eventually relapse or progress. Results from this pivotal study provide evidence that Carteyva® can result in high tumor remission rates and a manageable toxicity profile in r/r FL patient. Encouraged by these findings, we are looking forward to expanding the indications of Carteyva® use into r/r FL, hopefully benefiting more patients soon.”
Song, Y. et.al.; 63rd Annual ASH Meeting, 2021, abstract #2434, Atlanta, GA December 10th-14th
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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.
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 www.jwtherapeutics.com.