OCt 05, 2022
GSK announced positive results from PERLA, a head-to-head trial of Jemperli versus Keytruda
GSK announced that in the PERLA Phase 2 trial, Jemperli (dostarlimab) met the primary endpoint of objective response rate. The trial is evaluating the dostarilab plus chemotherapy combination versus pembrolizumab plus chemotherapy in first-line patients with metastatic non-small cell lung cancer (NSCLC).
PERLA trial included 243 patients, the largest head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in NSCLC. GSK announced that it was not designed to demonstrate superiority over Keytruda. The safety profile was consistent with the previous studies.
GSK also announced that it is advancing both the arms of the COSTAR trial into Phase 3. The COSTAR is an open-label trial comparing cobolimab, dostarlimab, and docetaxel combination versus dostarlimab plus docetaxel versus docetaxel alone in patients with NSCLC who have disease progression after PD-L1 therapy and chemotherapy.
Aug 15, 2022
Canakinumab failed to meet the primary endpoint in NSCLC patients.
Novartis gave an update on the Phase III CANOPY-A trial stating that canakinumab did not meet the primary endpoint in stages II-IIIA and IIIB completely resected non-small cell lung cancer patients. There was no improvement in the disease-free progression survival compared to placebo.
CANOPY-A trial recruited 1,382 patients and was randomized in 1:1 for canakinumab and placebo.
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.