China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb), Ketailai (KL-A167). This treatment is now approved for use in recurrent or metastatic nasopharyngeal carcinoma (NPC) patients who have previously failed second-line or above chemotherapy. Ketailai becomes the world’s first PD-L1 mAb to win a nod for NPC treatment.
Approval Based on Positive Phase II Study Results
The NMPA’s approval decision is based on the results from a single-arm, multi-center Phase II study. As of the data cut-off date, the study included a total of 132 patients in the full analysis set, with a median follow-up time of 21.7 months. The objective response rate (ORR), as evaluated by an independent review committee, was 26.5%. The median duration of response (DoR) was 12.4 months, and the median overall survival (OS) was 16.2 months, demonstrating the potential efficacy of Ketailai in treating NPC.
Implications for NPC Treatment Landscape
The approval of Ketailai marks a significant advancement in the treatment options available for patients with NPC, particularly those who have not responded to standard chemotherapy regimens. This development underscores the potential of PD-L1 mAbs in oncology and highlights Sichuan Kelun-Biotech’s contribution to the field.-Fineline Info & Tech
