In KEYNOTE-671, neoadjuvant pembrolizumab plus chemotherapy followed by surgery and adjuvant pembrolizumab improved event-free survival in early-stage NSCLC.
PD-1 and PD-L1 inhibitors are standard of care for advanced and metastatic NSCLC. Although recent phase 3 trials have shown benefits of PD-L1 inhibitors given before or after resection in early-stage NSCLC, many patients still experience recurrence. A perioperative approach including both neoadjuvant and adjuvant PD-L1 inhibition may provide a benefit beyond either approach alone.
The phase 3 KEYNOTE-671 (NCT03425643) evaluated the efficacy and safety of perioperative pembrolizumab in patients with resectable stage II, IIA, or IIIB NSCLC. Heather Wakelee, MD, presented the first results at the 2023 ASCO Annual Meeting, held June 2-6 in Chicago.
The study randomly assigned 797 patients 1:1 to neoadjuvant pembrolizumab plus chemotherapy (ie, cisplatin/gemcitabine or cisplatin/pemetrexed) followed by surgery and adjuvant pembrolizumab (pembrolizumab arm) or to neoadjuvant chemotherapy followed by surgery and adjuvant placebo (placebo arm).
Event-free survival (EFS) was significantly increased in the pembrolizumab arm compared with the placebo arm (HR, 0.58; P<0.00001). EFS rate at 24 months was 62.4% versus 40.6%, respectively. The benefit of pembrolizumab was observed in all prespecified subgroups. Participants with PD-L1 expression of 1% or greater had more benefit compared with patients with PD-L1 expression less than 1%: HR, 0.51 versus 0.77, respectively. Overall survival data are not yet mature but show a trend favoring pembrolizumab (HR, 0.73; P=0.021).
Both complete and major pathologic response was increased in the pembrolizumab arm compared with placebo: 18.1% versus 4.0% and 30.2% versus 11.0%, respectively. Exploratory analysis showed an EFS benefit for perioperative pembrolizumab regardless of whether patients achieved pathological complete response or major pathologic response.
“Data from KEYNOTE-671 support neoadjuvant pembrolizumab plus chemotherapy followed by surgery and adjuvant pembrolizumab as a promising new treatment option for patients with resectable stage II, IIIA, or IIIB NSCLC,” concluded Dr. Wakelee. “Screening programs can facilitate diagnosis of early-stage lung cancer.”
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