The findings from the phase 3 KEYNOTE-091 trial mark the first positive study for pembrolizumab in adjuvant stage IB-IIIA non-small cell lung cancer.
New study results with adjuvant pembrolizumab show statistically significant improvements in disease-free survival (DFS) among patients with stage IB-IIIA non-small cell lung cancer (NSCLC) regardless of programmed death-ligand 1 (PD-L1) expression, according to a press release from Merck.
“Keytruda has become foundational in the treatment of metastatic non-small cell lung cancer, and we continue to advance research to explore its potential to help fight cancer earlier,” said Roy Baynes, PhD, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories, in the press release. “We are encouraged by these results supporting the potential role of Keytruda in stage IB-IIIA non-small cell lung cancer.”
The findings from the phase 3 KEYNOTE-091 trial mark the first positive study for pembrolizumab in adjuvant stage IB-IIIA NSCLC, according to Merck. The trial met one of its dual primary endpoints of DFS for the adjuvant treatment of patients with stage IB-IIIA NSCLC following surgical resection regardless of PD-L1 expression.
The study enrolled 1177 patients who were randomly assigned to receive either placebo or pembrolizumab 200 mg intravenously every 3 weeks for 1 year or maximum 18 doses. Secondary endpoints include overall survival (OS) and lung cancer-specific survival.
Based on an interim analysis review, adjuvant treatment with pembrolizumab resulted in a statistically significant and clinically meaningful improvement in DFS compared with placebo in the all-comer patient population. However, this dual primary endpoint did not meet statistical significance per the pre-specified statistical plan.
The researchers will continue to analyze DFS in patients whose tumors express high levels of PD-L1 and will evaluate OS, which is a key secondary endpoint.
“Surgery is widely considered the first and most important intervention for most patients with early-stage non-small cell lung cancer; however an estimated 43% of those who undergo surgery will see their disease return,” said Mary O’Brien, MSc, co-principal investigator, in the press release. “Data from KEYNOTE-091 suggest adjuvant Keytruda reduced the risk of disease recurrence or death after surgery in the overall population of patients with stage IB-IIIA non-small cell lung cancer.”
The safety profile was consistent with what was observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.
“Globally, lung cancer is the leading cause of cancer death and it remains critically important to detect and treat lung cancer early,” said Luis Paz-Ares, MD, PhD, co-principal investigator, in the press release. “The goal of adjuvant treatment is to lower the risk of cancer returning after surgery. By moving Keytruda into earlier stages of non-small cell lung cancer, we may be able to reduce the risk of disease recurrence after surgery for patients with stage IB-IIIA non-small cell lung cancer.”
Merck’s Keytruda (pembrolizumab) showed statistically significant improvement in disease-free survival versus placebo as adjuvant treatment for patients with stage IB-IIIA non-small cell lung cancer regardless of PD-L1 expression. News release. Merck; January 10, 2022. Accessed January 13, 2022. https://www.merck.com/news/mercks-keytruda-pembrolizumab-showed-statistically-significant-improvement-in-disease-free-survival-versus-placebo-as-adjuvant-treatment-for-patients-with-stage-ib-iiia-non-small-cell/