Jan 10, 2022
Merck's Keytruda showed improvement in disease-free survival versus placebo in stage IB-IIIA NSCLC regardless of PD-L1 expression
Merck has announced that the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) stated that Keytruda had met the primary endpoint in Phase 3 KEYNOTE-091 trial.
Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), met one of its dual primary endpoints of disease-free survival (DFS) in patients stage IB-IIIA non-small cell lung cancer (NSCLC) following surgery, irrespective of the PD-L1 expression. Based on the independent Data Monitoring Committee results, Keytruda has met the primary endpoint in the interim analysis in patients with stage IB-IIIA NSCLC.
In the interim analysis, there was an improvement in the DFS in patients whose disease expressed PD-L1; however, it has not met the statistical significance. The company announced that the trial would evaluate DFS in patients whose tumors express a high level of PD-L1 and overall survival, a key secondary endpoint.
The safety profile is consistent with the existing safety profile of Keytruda.
AbbVie's telisotuzumab vedotin received breakthrough therapy designation from the US FDA
AbbVie has announced that it has received the breakthrough therapy designation from the US FDA for telisotuzumab vedotin to treat non-small cell lung cancer patients in the second line.
Telisotuzumab vedotin is an antibody-drug conjugate and is in development for advanced/metastatic epidermal growth factor receptor (EGFR) wild type, NSLCLC with c-Met overexpression. It is being evaluated in patients who were previously treated with platinum-based therapy.
Currently, there are no drugs for NSCLC with c-Met overexpression. AbbVie is currently conducting a Phase II trial, and a Phase III trial is being planned to start in the first half of 2022.
The breakthrough therapy designation was based on Phase II LUMINOSITY (Study M14-239) trial, in which the efficacy of telisotuzumab is being evaluated in NSCLC patients who overexpressed c-Met. The primary endpoint is the overall response rate in patients with ≥ 12 weeks follow-up.
In patients with EGFR WT nonsquamous NSCLC, the overall response rate was 53.8% in patients with high expression of c-Met and 25% in the c-Met intermediate group.
The drug is still under evaluation for efficacy and safety and has not received approval anywhere in the world.