JW Therapeutics Announces NMPA Acceptance of Supplemental New Drug Application for Carteyva® in Patients With Relapsed or Refractory Follicular Lymphoma
SHANGHAIFeb. 27, 2022 /PRNewswire/ — JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on the development, manufacturing and commercialization of cellular immunotherapy products, announced that the National Medical Products Administration (NMPA ) of China has accepted the supplemental new drug application (sNDA) for its autologous anti-CD19 antigen receptor (CAR-T) chimeric cellular immunotherapy product Carteyva® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL). This is the second marketing app on Carteyva® submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of patients with r/r FL. Carteyva® received Breakthrough Therapy Designation from the NMPA in September 2020.
The sNDA was supported by clinical results from Cohort B of a pivotal, single-arm, multicenter study (RELIANCE study) of Carteyva® in adult patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma China. The results of the study were presented at the 63rd Annual meeting of the American Society of Hematology (ASH) in December 2021. Results from Cohort B showed that Carteyva® demonstrated very high rates of durable disease response (best complete response rate and 3-month overall response rate were 92.6% and 100%, respectively) and controllable CAR-T-associated toxicities in patients with r/r FL (42.9% and 17.9% of patients had cytokine release syndrome (CRS) and neurotoxicity (NT) of any grade, while 0% and 3 .6% of patients had CRS and NT grade 3 or higher).
Professor Song YuqinChief Physician of Lymphoma Department of Peking University Cancer Hospital, Director of China Society of Clinical Oncology (CSCO), noted at the 63rd American Society of Hematology (ASH) Annual Meeting: “Results from the RELIANCE study show that Carteyva® has demonstrated a very excellent efficacy and safety profile in patients with r/r FL and we look forward to sNDA approval in China.”
About Relmacabtagene Autoleucel Injection (trade name: Carteyva®)
Relmacabtagene autoleucel injection (abbreviated 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 from Juno Therapeutics (a Bristol Myers Squibb company). As JW Therapeutics’ first product, relma-cel was approved by China’s 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 concurrently included in the National Significant New Drug Development Program, earned Priority Review and Breakthrough Therapy designations.
About the RELIANCE study (NCT04089215)
The RELIANCE study was a single-arm, multicenter pivotal study to evaluate the efficacy and safety of Carteyva® in adult patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (cohort A: relapsed or refractory large B-cell lymphoma, cohort B: relapsed or refractory follicular lymphoma) China.
The B RELIANCE cohort study enrolled 28 patients with r/r FL who had failed second-line (or higher) treatment, including an anti-CD20 agent and an anthracycline. Patients received 100*106 CAR-T or 150*106 Carteyva CAR-T cell® infusion and follow-up for up to 2 years or more for long-term results. From the deadline of September 10, 2021, out of 27 evaluable patients, the complete response rate (CRR) and overall response rate (ORR) at 3 months were 85.19% and 100%, and the best complete response rate and overall response rate were of 92.6% and 100%, respectively. Of 28 treated patients, 42.9% and 17.9% of patients had cytokine release syndrome (CRS) and neurotoxicity (NT) of any grade. Among these AEs, no CRS of grade 3 or higher occurred and only 3.6% of patients presented NT. 3rd year or higher.
About JW Therapeutics
JW Therapeutics (HKEx: 2126) is an independent, innovative biotechnology company focused on the development, manufacturing 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 cellular immunotherapy technology and product development, as well as a pipeline of promising products spanning both hematological malignancies and solid tumors, to bring hope to a cure for Chinese and global patients, and to lead the healthy and standardized development of China the cellular immunotherapy industry. For more information, please visit www.jwtherapeutics.com.
Forward-looking statements are based on 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 described in more detail in the Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise indicated, the Company provides this information as of the date of publication and expressly disclaims any obligation to update the information contained in the numbers and relevant information, or to provide any explanation. For detailed information, please visit the company’s website: www.jwtherapeutics.com/en/forward-looking-statements/.
SOURCE JW Therapeutic