China’s National Medical Products Administration (NMPA) has approved JW Therapeutics’ investigational new drug (IND) application for a key clinical trial of Carteyva (relmacabtagene autoleucel) in people with second-line large B-cell lymphoma. The trial started in April 2022.
Carteyva is an autologous anti-CD19 CAR T-cell immunotherapy for relapsed or refractory large B-cell lymphoma that has previously been authorised in China. Patients who have not achieved a complete response (or have relapsed within 12 months) on first-line therapies such as anthracyclines, Genentech/Rituxan Biogen’s (rituximab), or other CD20-targeting agents will be enrolled in the new Phase III trial, which will compare Carteyva to standard second-line therapy.
Prior to starting this study, JW completed the Phase II RELIANCE trial, which saw a 75.9% overall response rate to Carteyva and a 51.7 percent complete response rate. With a median follow-up time of 17.9 months, overall survival was 76.8%. Carteyva was approved by Chinese regulators in 2021 for relapsed or refractory large B-cell lymphoma based on this research.
Large B-cell lymphomas are the most prevalent subtype of B-cell lymphomas, which account for 85 percent of non-Hodgkin lymphomas. The conventional first-line treatment is rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, R-CHOP does not cure 30 to 50 percent of patients, who either relapse or become chemo-resistant. Salvage immunotherapy followed by high-dose chemotherapy and stem cell transplantation has been the traditional second-line therapy for large B-cell lymphoma for decades, but it only works approximately a quarter of the time.
Juno Therapeutics’ orvacabtagene autoleucel was generated from the same CAR design as Carteyva. Juno, a Bristol Myers Squibb company, and Shanghai-based WuXi AppTec partnered to become JW in 2016.
JW is working on CAR T-cell treatments for multiple myeloma and follicular lymphoma, in addition to large B-cell lymphoma. JW’s IND to examine their BCMA-targeted CAR T-cell treatment JWCAR129 in relapsed or refractory multiple myeloma was approved by the NMPA last year. JW’s new medication application for Carteyva in relapsed or refractory follicular lymphoma was accepted by the FDA in early March.
