China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving another clearance from the National Medical Products Administration (NMPA) for its PD-L1 monoclonal antibody (mAb) Ketailai (tagitanlimab). The latest approval indicates the drug for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) when combined with chemotherapy. This follows last month’s endorsement for its use in NPC patients who have previously failed second-line or above chemotherapy.
Phase III Study Results
The NMPA’s decision was based on results from a randomized, double-blinded, placebo-controlled, multi-center Phase III study assessing the efficacy and safety of tagitanlimab combined with chemotherapy versus placebo/chemo combo in recurrent or metastatic NPC. Results showed that the tagitanlimab and chemotherapy group did not reach the median progression-free survival (PFS), compared to a median PFS of 7.9 months in the placebo and chemotherapy group (unilateral p<0.0001). The risk of disease progression or death was reduced by 53%.
Efficacy and Safety Data
The objective response rate (ORR) was 81.7% in the tagitanlimab group versus 74.5% in the placebo group. The median duration of response (DoR) was 11.7 months for tagitanlimab versus 5.8 months for the placebo group, nearly twice as long. Although the median overall survival (OS) is not yet mature, a beneficial trend in overall survival was observed with tagitanlimab (HR=0.62, 95% CI: 0.32-1.22), representing a 38% reduction in mortality risk. Tagitanlimab also demonstrated good safety.-Fineline Info & Tech
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