Multicenter phase 2 trial of perioperative pembrolizumab in early-stage non-small cell lung cancer

A multicenter phase 2 trial in the USA evaluated perioperative pembrolizumab in early-stage non-small-cell lung cancer (NSCLC). Patients with previously untreated stage IB to IIIA NSCLC received two doses of 200 mg pembrolizumab, surgery, standard adjuvant chemotherapy, followed by four doses adjuvant pembrolizumab. Among 30 included patients, 25 completed tumor resection. Major pathological response, defined as less than or equal to 10% of viable tumor remaining at time of surgery, was seen in seven patients (28%) with complete pathological response in two patients. The two patients with complete pathological response did not experience disease progression, recurrence or death at time of final analysis. At median follow-up of 59 months after surgical resection, seven patients had disease progression, while six had died. The 5-year progression-free survival rate from time of surgery was 72.0% (95% CI 56.4-91.9), while the 5-year overall survival rate was 75.8% (60.7-94.7). Grade 3 or 4 treatment-related adverse events were seen in four patients receiving neoadjuvant pembrolizumab and four patients receiving adjuvant pembrolizumab. There were no grade 5 TRAEs. The authors conclude that among patients with early-stage NSCLC, perioperative pembrolizumab was safe and effective.