Phase 2 trial of neoadjuvant sintilimab plus chemotherapy in EGFR-mutant non-small cell lung cancer

The phase 2 NEOTIDE trial, at Guangdong Provincial People’s Hospital (China), evaluated neoadjuvant sintilimab (anti-PD-1) combined with chemotherapy in patients with resectable stage II-IIIB EGFR-mutant non-small cell lung cancer (NSCLC). Thiry-five patients received three 3-week cycles of sintilimab plus carboplatin and nab-paclitaxel followed by surgery. Primary endpoint was major pathologic response (MPR) rate. Among 33 patients who underwent resection (R0 resection in 87.9%), the MPR rate was 34.3% (95% CI 19.1-52.2), meeting the primary endpoint. The objective response rate was 60.0% and the pathological complete response rate was 11.4%. The median follow-up was 33.7 months. The median event-free survival (EFS) was not reached, with a 2-year EFS rate of 71.4% (95% CI 57.9-88.1). Among 18 patients who were observed, the median EFS was 23.9 months, and among the 17 patients who received adjuvant osimertinib, the median EFS was not reached. The safety profile during neoadjuvant treatment was tolerable, with 29% of patients experiencing grade 3-4 adverse events. The authors conclude that neoadjuvant sintilimab plus chemotherapy demonstrated encouraging activity and tolerability among patients with EFGR-mutant resectable NSCLC.