Perioperative pembrolizumab plus platinum-based chemotherapy

The phase III double-blind KEYNOTE-671 (NCT03425643) trial included 797 patients with untreated stage II, IIIA, or IIIB (≥1 ipsilateral mediastinal node or subcarinal node) NSCLC. Patients were randomly assigned to receive neoadjuvant pembrolizumab (200 mg every 3 weeks) or placebo with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles, or until disease progression or unacceptable toxicity. The dual primary end points were EFS (defined as the time from randomization to local progression precluding surgery, unresectable tumor, progression or recurrence, or death) and OS. At the second interim analysis, the median follow-up was 36.6 months (range, 27.6–47.8).[22][Level of evidence A1]

The phase III double-blind KEYNOTE-671 (NCT03425643) trial included 797 patients with untreated stage II, IIIA, or IIIB (≥1 ipsilateral mediastinal node or subcarinal node) NSCLC. Patients were randomly assigned to receive neoadjuvant pembrolizumab (200 mg every 3 weeks) or placebo with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles, or until disease progression or unacceptable toxicity. The dual primary end points were EFS (defined as the time from randomization to local progression precluding surgery, unresectable tumor, progression or recurrence, or death) and OS. At the second interim analysis, the median follow-up was 36.6 months (range, 27.6–47.8).[22][Level of evidence A1]

The median EFS was 47.2 months (95% CI, 32.9–NR) in the pembrolizumab group and 18.3 months (95% CI, 14.8–22.1) in the placebo group (HR, 0.59; 95% CI, 0.48–0.72).

The phase III double-blind KEYNOTE-671 (NCT03425643) trial included 797 patients with untreated stage II, IIIA, or IIIB (≥1 ipsilateral mediastinal node or subcarinal node) NSCLC. Patients were randomly assigned to receive neoadjuvant pembrolizumab (200 mg every 3 weeks) or placebo with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles, or until disease progression or unacceptable toxicity. The dual primary end points were EFS (defined as the time from randomization to local progression precluding surgery, unresectable tumor, progression or recurrence, or death) and OS. At the second interim analysis, the median follow-up was 36.6 months (range, 27.6–47.8).[22][Level of evidence A1]

The 36-month OS rate estimates were 71% (95% CI, 66%–76%) in the pembrolizumab group and 64% (95% CI, 58%–69%) in the placebo group (HR, 0.72; 95% CI, 0.56–0.93; one-sided P = .0052; threshold, one-sided P = .0054).

The phase III double-blind KEYNOTE-671 (NCT03425643) trial included 797 patients with untreated stage II, IIIA, or IIIB (≥1 ipsilateral mediastinal node or subcarinal node) NSCLC. Patients were randomly assigned to receive neoadjuvant pembrolizumab (200 mg every 3 weeks) or placebo with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles, or until disease progression or unacceptable toxicity. The dual primary end points were EFS (defined as the time from randomization to local progression precluding surgery, unresectable tumor, progression or recurrence, or death) and OS. At the second interim analysis, the median follow-up was 36.6 months (range, 27.6–47.8).[22][Level of evidence A1]

Secondary end points were reported as follows:

The phase III double-blind KEYNOTE-671 (NCT03425643) trial included 797 patients with untreated stage II, IIIA, or IIIB (≥1 ipsilateral mediastinal node or subcarinal node) NSCLC. Patients were randomly assigned to receive neoadjuvant pembrolizumab (200 mg every 3 weeks) or placebo with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles, or until disease progression or unacceptable toxicity. The dual primary end points were EFS (defined as the time from randomization to local progression precluding surgery, unresectable tumor, progression or recurrence, or death) and OS. At the second interim analysis, the median follow-up was 36.6 months (range, 27.6–47.8).[22][Level of evidence A1] › Secondary end points were reported as follows:

Major pathological response occurred in 30.2% of patients in the pembrolizumab group and 11.0% of patients in the placebo group (P < .0001).

The phase III double-blind KEYNOTE-671 (NCT03425643) trial included 797 patients with untreated stage II, IIIA, or IIIB (≥1 ipsilateral mediastinal node or subcarinal node) NSCLC. Patients were randomly assigned to receive neoadjuvant pembrolizumab (200 mg every 3 weeks) or placebo with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles, or until disease progression or unacceptable toxicity. The dual primary end points were EFS (defined as the time from randomization to local progression precluding surgery, unresectable tumor, progression or recurrence, or death) and OS. At the second interim analysis, the median follow-up was 36.6 months (range, 27.6–47.8).[22][Level of evidence A1] › Secondary end points were reported as follows:

Pathological complete response occurred in 18.1% of patients in the pembrolizumab group and 4.0% of patients in the placebo group (P < .0001).

The phase III double-blind KEYNOTE-671 (NCT03425643) trial included 797 patients with untreated stage II, IIIA, or IIIB (≥1 ipsilateral mediastinal node or subcarinal node) NSCLC. Patients were randomly assigned to receive neoadjuvant pembrolizumab (200 mg every 3 weeks) or placebo with cisplatin-based chemotherapy for four cycles, followed by surgery and adjuvant pembrolizumab or placebo for up to 13 cycles, or until disease progression or unacceptable toxicity. The dual primary end points were EFS (defined as the time from randomization to local progression precluding surgery, unresectable tumor, progression or recurrence, or death) and OS. At the second interim analysis, the median follow-up was 36.6 months (range, 27.6–47.8).[22][Level of evidence A1]

Grade 3 to 5 treatment-related adverse events occurred in 179 of 396 patients (45%) in the pembrolizumab group and in 151 of 399 patients (38%) in the placebo group. Treatment-related adverse events led to death in four patients (1%) in the pembrolizumab group and three patients (1%) in the placebo group.