JW Therapeutics Presents Primary Clinical Response to Carteyva® (Relmacabtagene Autoleucel Injection) in Adults with Relapsed / Refractory Follicular Lymphoma in China at 63rd ASH Annual Meeting | News


SHANGHAI, December 14, 2021 / PRNewswire / – JW Therapeutics (HKEx: 2126), an independent innovative biotechnology company focused on the development, manufacture and commercialization of cellular immunotherapy products, presented the leading clinical response on Carteyva® (relmacabtagene autoleucel injection) in adults with relapsed / refractory follicular lymphoma (r / r FL) in China at the 63rd Annual Meeting of the American Society of Hematology (ASH).

On the cut-off date for September 10, 2021, 28 patients were treated with Carteyva® with at least three months of follow-up.

Of 27 patients evaluable in terms of efficacy, as evaluated by the investigator, the best overall response rate (ORR) was 100% (27/27) and the 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 achieved.

In 28 patients who received Carteyva®, cytokine release syndrome (CRS) of any grade and severe (grade ≥ 3) was 42.9% and 0%, respectively, and neurotoxicity (NT) of any grade and severe (grade ≥ 3) were 17.9% and 3.6%, respectively.

Dr. Mark J. Gilbert, Medical Director of JW Therapeutics, commented, “Most patients with r / r FL remain incurable and eventually relapse or progress. The results of this pivotal study provide evidence that Carteyva® may result in high tumor remission rates and a manageable toxicity profile in patients with r / r FL. Encouraged by these results, we look forward to expanding the indications of Carteyva® use in r / r FL, which will hopefully benefit more patients soon. “

Reference:

Song, Y. et al .; 63rd ASH Annual Meeting, 2021, Abstract # 2434, Atlanta, GA, December 10e-14e

About Relmacabtagene Autoleucel Injection (trade name: Carteyva®)

Relmacabtagene autoleucel injection (abbreviated relma-cel, trade name: Carteyva®) is an autologous anti-CD19 CAR-T immunotherapy product that was independently developed by JW Therapeutics based on a CAR T cell processing platform from Juno Therapeutics (a Bristol Myers Squibb company). JW Therapeutics’ first product, 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 following two or more lines of systemic therapy, making it the first CAR-T product approved as a Category 1 biologic in China. Currently, it is the only CAR-T product in China which was simultaneously included in the National Major New Drug Development Program, which received Priority Review and Breakthrough Therapy designations.

About JW Therapeutics

JW Therapeutics (HKEx: 2126) is an independent and innovative biotechnology company focused on the development, manufacture and commercialization of cellular 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 cellular immunotherapy. The company has built a world-class platform for the development of technologies and products in cell immunotherapy, as well as a pipeline of promising products covering both hematologic malignancies and solid tumors, to bring hope to healing to Chinese and global patients, and to lead the healthy and standardized development of from China cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.

Forward-looking statements

Forward-looking statements are based on the expectations and beliefs of management and are subject to a number of risks and uncertainties which could cause actual results to differ materially from those described. Material risks and uncertainties include those discussed below and further described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise specified, the Company is providing this information on the date of its publication and expressly disclaims any obligation to update the information contained in the relevant issues and information, or to provide any explanation. For detailed information, please visit the company’s website: www.jwtherapeutics.com/en/forward-looking-statements/.

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SOURCE JW Therapeutics


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