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1. 36-month overall survival and median event-free survival were significantly greater in the pembrolizumab group compared to control.

2. Grade 3-5 adverse events were comparable between both treatment groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Pembrolizumab combined with neoadjuvant chemotherapy has shown promise in improving event-free survival among patients with early-stage non-small-cell lung cancer (NSCLC). The KEYNOTE-671 trial sought to assess the impact of adding perioperative pembrolizumab to standard chemotherapy and surgery on overall survival and health-related quality of life. The primary outcome was mean overall survival while key secondary outcome was event-free survival. According to study results, patients in the pembrolizumab group reported a significant survival benefit compared to the placebo group. Although this study was well done, it was limited by a relatively short follow-up duration to assess long-term outcomes.

Click to read the study in The Lancet

Relevant Reading: Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer

In-depth [randomized-controlled trial]: Between May 11, 2018, and Dec 15, 2021, 1364 patients were screened for eligibility across 189 medical centers. Included were patients ≥ 18 years with resectable stage II, IIIA, or IIIB (N2) NSCLC who were eligible for neoadjuvant chemotherapy followed by surgery. Altogether, 797 patients (397 in pembrolizumab and 400 in placebo) were included in the final analysis. The primary outcome of 36-month overall survival was significantly greater in the pembrolizumab group compared to placebo (71% vs. 64%, hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.56-0.93, one-sided p=0.0052). The secondary outcome of median event-free survival followed a similar trend (47.2 months for pembrolizumab vs. 18.3 months for placebo, HR 0.59, 95% CI 0.48-0.72). Findings from this study suggest that perioperative pembrolizumab improves survival outcomes in patients with early-stage, resectable NSCLC.

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