NEW YORK – JW Therapeutics said Thursday that China's National Medical Products Administration (NMPA) cleared its investigational new drug (IND) application for a pivotal clinical trial of Carteyva (relmacabtagene autoleucel) in second-line large B-cell lymphoma.
Carteyva is an autologous anti-CD19 CAR T-cell immunotherapy already approved in China for relapsed or refractory large B-cell lymphoma. The new Phase III trial will compare Carteyva to standard second-line therapy in patients who have not achieved complete response (or have relapsed within 12 months) on first-line therapies such as anthracyclines, Genentech/Biogen's Rituxan (rituximab), or other CD20-targeting agents.
Prior to launching this study, JW conducted the Phase II RELIANCE trial, in which there was a 75.9 percent overall response rate to Carteyva and a complete response rate of 51.7 percent. Overall survival was 76.8 percent with a median follow-up time of 17.9 months. Chinese regulators approved Carteyva based on this data in 2021 for relapsed or refractory large B-cell lymphoma.
B-cell lymphomas comprise 85 percent of non-Hodgkin lymphomas and in this subset, large B-cell lymphomas are the most common subtype. Rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is the standard first-line treatment. However, 30 to 50 percent of patients are not cured by R-CHOP and either relapse or become refractory to chemo. For decades, the standard second-line therapy for large B-cell lymphoma has been salvage immunotherapy followed by high-dose chemo and stem cell transplantation, but it is successful only about a quarter of the time.
Carteyva was derived from the same CAR construct as Juno Therapeutics' orvacabtagene autoleucel. JW was launched in 2016 as a joint venture of Juno, a Bristol Myers Squibb subsidiary, and Shanghai-based WuXi AppTec.
In addition to large B-cell lymphoma, JW is developing CAR T-cell therapies for multiple myeloma and follicular lymphoma. Last year, the NMPA cleared JW's IND to study its BCMA-targeted CAR T-cell therapy JWCAR129 in relapsed or refractory multiple myeloma. And in early March, the agency accepted JW's new drug application for Carteyva in relapsed or refractory follicular lymphoma.