Preliminary efficacy
DISEASE PROGRESSION, EVENTS
For the intention-to-treat population, based on blinded independent pathological review (BIPR), the primary endpoint of MPR was 50.0% (26/52, 95% CI 35.8–64.2%), whereas the pCR rate was 25.0% (13/52, 95% CI 14.0–38.9%) (Fig. Pathological evaluation of responses to neoadjuvant nivolumab with or without chemotherapy on the basis of PD-L1 expression. As resected specimens were not available for six patients who received treatment without undergoing surgery, a sensitivity analysis was carried out to examine the MPR and pCR rates in those who underwent surgical resection. Among the 46 patients resected in the trial, a significantly higher incidence of MPR in the N/C group was observed than that in the N group among the patients with ≥ 50% PD-L1 expression (80.0% vs.18.2%, odds ratio = 14.85, 95% CI 1.50–64.91, In all treated populations, the overall response rate (ORR) was 55.8% (29/52, 95% CI 41.3–69.5%), whereas in the N group and N/C group, the ORRs were 41.7% (5/12, 95%CI 15.2–72.3%) and 60% (24/40, 43.3–75.1%), respectively (Supplementary Table With a median follow-up of 25.1 months for the entire enrolled population (95% CI 22.0–27.7 months, range 0.07–32.7 months), neither the median EFS nor the median OS was reached. Nine (17.3%) of the 52 patients experienced disease progression or died, two of whom (3.8%) did not undergo surgery (Fig. Swimmer plot depicting events in all enrolled population (