Collumbotai Bio-B (06990): Anti-PD-L1 tagolimab approved for marketing by the State Drug Administration

Zhitongcaijing · 01/20 12:17

According to the Zhitong Finance App, Columbotai Bio-B (06990) announced that the company, along with cisplatin and gemcitabine, has been approved by China's National Drug Administration (NMPA) for the innovative humanized monoclonal antibody tagolimab (previously known as KL-A167) (KL-A167) (Cotailai®) for first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC). PD-L1

The approval was mainly based on a randomized, double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of tagolimab combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal cancer with cisplatin and gemcitabine. Research results show that compared with chemotherapy, first-line treatment of recurrent or metastatic nasopharyngeal cancer with cisplatin and gemcitabine can obtain better progression-free survival (PFS), higher objective remission rate (ORR), and longer duration of remission (DoR), and can benefit regardless of the patient's PD-L1 expression. The median PFS in the combination chemotherapy group with tagolimab was not achieved. The median PFS with placebo chemotherapy reached 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), which is nearly 1 times longer than the placebo group; currently, median overall survival (OS) is still immature, but has been observed The overall survival benefit trend of anti-combination chemotherapy (HR = 0.62, 95% CI: 0.32-1.22) reduced the risk of death by 38% 1. Tagolimab also showed good safety.

This is the second indication for which tagolimab was approved. Previously, the NMPA had approved tagolimab monotherapy for the treatment of patients with recurrent or metastatic nasopharyngeal cancer who had previously received second-line chemotherapy and failed to be marketed in China.