SKB BIO-B (06990): The anti-PD-L1 antibody Tegolimab has obtained approval from the National Medical Products Administration for marketing.

SKB BIO-B (06990) announced that the innovative humanized monoclonal antibody Tegolimab (formerly known as KL-A167) used in combination with cisplatin and gemcitabine for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) patients targeting Programmed Death Ligand 1 (PD-L1) has been approved by the National Medical Products Administration (NMPA) for the Chinese market. The approval was based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study evaluating the efficacy and safety of Tegolimab in combination with cisplatin and gemcitabine compared to placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic nasopharyngeal carcinoma. The study results showed that compared to chemotherapy, Tegolimab in combination with cisplatin and gemcitabine as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma achieved superior progression-free survival (PFS), higher objective response rate (ORR), and longer duration of response (DoR), with benefits observed regardless of patient PD-L1 expression. The median PFS in the Tegolimab combination group was not reached, while in the placebo combination group it was 7.9 months (HR=0.47, 95% CI: 0.33-0.66, one-sided p<0.0001), reducing the risk of disease progression or death by 53%; ORR was 81.7% vs 74.5%; median DoR was 11.7 vs 5.8 months (HR=0.48, 95% CI: 0.32-0.70), extending nearly twice as long as the placebo group; the median overall survival (OS) is still immature, but a trend of benefit in OS with Tegolimab combination therapy has been observed (HR=0.62, 95% CI: 0.32-1.22), reducing the risk of death by 38%. Tegolimab also demonstrated good safety profile. This is the second indication for which Tegolimab has been approved. Previously, NMPA had approved Tegolimab as a monotherapy for the treatment of recurrent or metastatic nasopharyngeal carcinoma patients in China who had previously failed 2nd-line or higher chemotherapy.