On August 27, 2024, the China NMPA has approved new indication, mantel cell lymphoma (MCL), to Carteyva (Relma-cel), this is the third indication approved for this innovative CAR T-cell therapy.
Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell therapy product, it is developed based on the cell processing platform of Breyanzi, an FDA approved CAR T-cell therapy product for the treatment of various types of lymphoma.
In September 2021, Carteyva was first approved in China for the treatment of adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of therapy. In October 2022, it received approval for the treatment of relapsed or refractory follicular lymphoma (r/r FL), and recently it was approved for relapsed or refractory mantle cell lymphoma (r/r MCL). With these approvals, Relma-cel has become the first CAR-T product in China to have three approved indications!
Carteyva has previously received breakthrough therapy designation from the NMPA in March 2022 and priority review in December 2023. It is currently the only CAR-T cell product in China to have received the honors of breakthrough therapy designation, priority review for new drug application, and significant new drug creation program recognition.
Carteyva: Nearly 70% Complete Remission Rate in Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is an aggressive subtype of B-cell non-Hodgkin lymphoma. After treatment failure, patients typically have a poor overall response rate (ORR) and a high recurrence rate, with a median overall survival (OS) of only 6 to 10 months.
The approval of Carteyva brings hope to patients with relapsed or refractory mantle cell lymphoma (r/r MCL). Results from a Phase II clinical study (NCT04718883) were presented at the 2022 American Society of Hematology (ASH) Annual Meeting. The study enrolled patients with mantle cell lymphoma who had previously received at least two lines of therapy (including BTK inhibitors, anti-CD20 antibodies, bendamustine, or anthracyclines). Following enrollment, patients underwent lymphocyte-depleting chemotherapy followed by Relma-cel infusion.
The results indicated that Carteyva demonstrated a high response rate in patients with relapsed or refractory mantle cell lymphoma, with a best overall response rate (ORR) of 78.57% and a best complete response rate (CRR) of 66.67%. At three months of treatment, among the 42 assessable patients, 64.29% (27 patients) achieved an objective response (ORR), and 54.76% (23 patients) achieved complete remission (CR).
