Keytruda Boosts Survival Rate for Non-Small Cell Lung Cancer
The randomized Phase 3 trial found that Merck’s Keytruda decreased the risk of disease recurrence or death by 24% compared to placebo in non-small cell lung cancer patients.
Merck and the European Thoracic Oncology Platform (ETOP) recently announced that Keytruda significantly improved disease-free survival (DFS) in patients with stage IB to IIA non-small cell lung cancer (NSCLC) in a Phase 3 clinical trial.
The randomized KEYNOTE-091 trial enrolled 1,177 patients to receive either 200 milligrams of Keytruda every three weeks or a placebo. Overall, the trial found that Keytruda decreased the risk of disease recurrence or death by 24% compared to placebo. And the median DFS was 53.6 months for Keytruda and 42.0 months for placebo.
Researchers also noted an improvement in DFS for patients whose tumors express PD-L1 treated with Keytruda compared to placebo. These results did not reach statistical significance per the pre-specified statistical plan.
The trial will continue to evaluate DFS and overall survival (OS) in patients. The safety profile for Keytruda in this study was consistent with that observed in previously reported studies.
“These are the first positive results for Keytruda in the adjuvant setting for non-small cell lung cancer , and represent the sixth positive pivotal study evaluating a Keytruda-based regimen in earlier stages of cancer,” Roy Baynes, MD, senior vice president and head of global clinical development, chief medical officer at Merck, said in the announcement.
“Keytruda has become foundational in the treatment of metastatic non-small cell lung cancer, and we are pleased to present these data showing the potential of KEYTRUDA to help more patients with lung cancer in earlier stages of disease. We thank the patients, their caregivers, and investigators for participating in this study,” Baynes continued.
In addition to KEYNOTE-091, five other trials evaluating a Keytruda-based regimen in patients with earlier stages of cancer met their primary endpoints.
These trials included : KEYNOTE-716 in stage IIB and IIC melanoma, KEYNOTE-054 in stage III melanoma, KEYNOTE-564 in renal cell carcinoma, KEYNOTE-522 in triple-negative breast cancer, and KEYNOTE-057 in Bacillus Calmette–Guerin (BCG)-unresponsive, high-risk, non-muscle-invasive bladder cancer.
In 2019, FDA approved Keytruda as a first-line treatment for patients with stage III NSCLC who are not candidates for surgical resection, definitive chemoradiation, or metastatic NSCLC.
Overall, the trial demonstrated statistically significant OS improvements for those randomized to Keytruda compared with chemotherapy in all three populations. And there were no significant differences in progression-free survival or overall response rate between arms in any population.
