JW Therapeutics Presents Primary Clinical Response on Carteyva® (relmacabtagene autoleucel injection) in Adults with Relapsed/Refractory Follicular Lymphoma in China at the 63rd ASH Annual Meeting
SHANGHAI, Dec. 14, 2021 /PRNewswire/ -- 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."
Reference: |
Song, Y. et.al.; 63rd Annual ASH Meeting, 2021, abstract #2434, Atlanta, GA December 10th-14th |
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 products that was independently developed by JW Therapeutics based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). 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 a 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.
Forward-Looking Statements
The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.
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