JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with recurrent or refractory mantle cell lymphoma (r/r MCL) who have undergone second-line or above systemic treatment, including the use of Bruton tyrosine kinase inhibitors (BTKis).
The autologous anti-CD19 CAR-T cell immunotherapy, originally developed by JW Therapeutics, previously received approval in China for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after at least two lines of systemic therapy. It was also approved for adult patients with follicular lymphoma (FL) that is refractory or relapses within 24 months of second-line or above systemic treatment. In October 2022, the drug obtained a second indication for use in second-line or above r/r FL.
The latest approval is supported by the outcomes of a single-arm, multi-center, pivotal Phase II study for Carteyva. The study involved patients with r/r MCL who had received targeted CD20 antibodies, anthracyclines or bendamustine, and BTKis. Participants were administered 100 × 106 CAR+T cells following lymphodepletion. As of August 7, 2023, a total of 59 patients had undergone reinfusion. Among the 59 patients eligible for efficacy evaluation, Carteyva demonstrated a robust clinical response, achieving high overall response rates (ORR) and complete response rates (CRR), with optimal ORR of 81.36% and optimal CRR of 67.80%. The incidence of severe cytokine release syndrome (CRS) of grade 3 or higher was 6.8%, and the incidence of severe neurotoxicity (NT) of grade 3 or higher was also 6.8%.- Flcube.com
