Pembrolizumab was superior to chemotherapy in terms of both progression-free survival, the primary endpoint, and overall survival in patients with previously untreated, advanced non-small cell lung cancer (NSCLC), according to findings from the KEYNOTE-024 trial.1
“We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer,” said Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories. “We look forward to sharing these data with the medical community and with regulatory authorities around the world.”
For this phase 3 trial, investigators enrolled 305 patients who had received no prior systemic treatment for their advanced disease and whose tumors expressed high levels of PD-L1. Participants were randomly assigned to receive pembrolizumab 200 mg IV every 3 weeks or standard of care platinum-based chemotherapy (paclitaxel plus carboplatin, pemetrexed plus carboplatin or cisplatin, or gemcitabine plus carboplatin or cisplatin). Patient with non-squamous histologies were eligible to receive pemetrexed maintenance therapy as well, and patients who experienced disease progression while in the control arm could cross over to pembrolizumab.
The toxicity profile was consistent with what was observed in previous studies in patients with advanced NSCLC. The most common adverse events were fatigue, decreased appetite, dyspnea, and cough. Serious immune-mediated pneumonitis, colitis, endocrinopathies, and nephritis may also occur with pembrolizumab.
An independent Data Monitoring Committee has recommended that the trial be stopped and that patients receiving chemotherapy be offered pembrolizumab.
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Pembrolizumab, a PD-1-blocking antibody, is indicated for patients with metastatic NSCLC whose tumors express PD-L1 and who have disease progression on or after platinum-containing chemotherapy. It is also approved for patients with unresectable or metastatic melanoma.
- Merck’s KEYTRUDA® (pembrolizumab) demonstrates superior progression-free and overall survival compared to chemotherapy as first-line treatment in patients with advanced non-small cell lung cancer [news release]. Kenilworth, NJ: Merck; June 16, 2016. http://www.mercknewsroom.com/news-release/oncology-newsroom/mercks-keytruda%C2%A0pembrolizumab-demonstrates-superior-progression-free-. Accessed June 21, 2016.