Pembrolizumab: beneficial for more lung cancer patients21 Dec 2015
More patients with advanced non-small-cell lung cancer (NSCLC) could benefit from pembrolizumab, says Professor Roy Herbst, Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven. These are the promising results from the pivotal phase 2/3 KEYNOTE-010 trial.
The study included patients from 24 countries
The open-label KEYNOTE-010 is the first study to assess the benefits of immunotherapy as second- or later line in patients with refractory lung cancer selected for PD-L1 expression. From August 2013 to April 2015, 1034 patients with advanced NSCLC from 24 countries (EU nations, US and Asia, including Japan, South Korea and Taiwan) were randomized to pembrolizumab (2 mg/kg or 10 mg/kg) or docetaxel.
All patients had experienced disease progression after platinum-containing systemic therapy and were stratified by PD-L1 expression level.
Improved median survival with pembrolizumab
The study shows that:
- Two doses of the anti-PD-1 antibody pembrolizumab, the US FDA-approved 2 mg/kg dose and an investigational 10 mg/kg dose, each given every 3 weeks, improve median survival in all PD-L1-positive patients compared with the commonly used chemotherapeutic agent docetaxel.
- The benefit is even greater in the group of patients with PD-L1 staining in ≥50% of tumor cells.
“The topline results show that both groups of patients receiving pembrolizumab experience a survival benefit compared to docetaxel,” Herbst said. He added that “treatment with pembrolizumab was associated with longer overall survival compared to docetaxel.
In this trial, the safety profile of pembrolizumab was consistent with that from previous NSCLC studies. “The drug is not yet approved in Asia and in Europe, and this study could help in this direction.” Dr Ross Soo, Adjunct Principal Investigator, Cancer Science Institute of Singapore, who was not involved in the study, said.
Can all patients benefit from pembrolizumab?
This year, another drug targeting the PD-1/PD-L1 pathway, nivolumab, received approval for the treatment of advanced-stage NSCLC without any required biomarker selection of patients. “The hazard ratio for overall survival favors pembrolizumab as compared with the recently approved second-line treatment options in advanced stage NSCLC such as docetaxel plus ramucirumab or docetaxel plus nintedanib,” Soo said.
“However, cross-trial comparisons should be interpreted with caution. In the absence of a direct head-to-head comparison, the choice of the specific PD-1 inhibitor relies on different factors such as costs of treatment, scheduling, and availability of biomarker testing.”
Future studies are needed to assess whether patients who express PD-L1 in less than 1% of tumor cells would have some benefits from pembrolizumab.Source: eCancer News