On April 3, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) in patients with mantle cell lymphoma (MCL) (Press release, JW Therapeutics, APR 3, 2022, View Source [SID1234611376]). Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics.
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The Breakthrough Therapy Designation was supported by the results from the clinical study of Carteyva in relapsed or refractory MCL (r/r MCL), which aimed to assess the efficacy and safety of Carteyva in adults with r/r MCL in China. This is the first clinical result obtained in Chinese patients.
MCL is a non-Hodgkin lymphoma, which is highly aggressive and can’t be cured by the currently approved therapies1. About 80% to 90% of MCL patients were diagnosed at the advanced stage and with poor prognoses2. Despite a few novel mechanism-of-action drugs such as Bruton tyrosine kinase inhibitors (BTKi) have improved outcomes for patients living with this disease, subsets of patients with aggressive disease biology or multiply relapsed disease continue to experience relatively poor outcomes with these currently available therapies. There are still urgent unmet medical needs to develop additional active therapeutic agents for the treatment of r/r MCL.
References
1. The consensus of the diagnosis and treatment of mantle cell lymphoma in China (2016 version) .Chin J Hematol.2016, 37(9):735-741.
2. Herrmann A, Hoster E, Zwingers T, et al. Improvement of Overall Survival in Advanced Stage Mantle Cell Lymphoma[J]. Journal of Clinical Oncology, 2009, 27(4):511-518.
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 JWCAR029-005 Study (NCT04718883)
This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva in adults with r/r MCL in China. This is the first clinical study to evaluate such novel therapy in Chinese MCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients.
This study will enroll a total of 59 r/r MCL patients either relapsed or refractory to second-line or more line regimens. Prior therapies must include an anti-CD20 monoclonal antibody, anthracycline- or bendamustine-containing chemotherapy, and BTK inhibitor therapy. These patients will be followed up for long-term survival in 2 years or above.
The study is currently ongoing. Preliminary clinical data found Carteyva providing outstanding efficacy and good safety profile for r/r MCL patients. In particular, Carteyva provided clear therapeutic benefits to patient refractory or relapsed to BTK inhibitor therapy.