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Perioperative Durvalumab for Resectable NSCLC

Perioperative durvalumab improved outcomes in patients with resectable non–small-cell lung cancer (NSCLC) in a study of neoadjuvant/adjuvant immunotherapy. The authors write, “Perioperative regimens that combine the benefits of neoadjuvant and adjuvant immunotherapy could further improve long-term outcomes (as suggested by results of recent melanoma and NSCLC trials) by priming antitumor immunity while the primary tumor and lymph nodes are present and eradicating residual micrometastases both before and after surgery.”

Durvalumab — a selective, high-affinity, human IgG1 monoclonal antibody that inhibits interaction of PD-L1 with PD-1 and CD80 by binding to PD-L1 — was administered to patients with resectable NSCLC (stage II to IIIB [N2 node stage]. With platinum-based chemotherapy, durvalumab or placebo was administered intravenously every 3 weeks for 4 cycles before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles.

Based on primary endpoints of event-free survival (earliest occurrence of progressive disease that precluded surgery or prevented completion of surgery, disease recurrence, or death from any cause) and pathological complete response, the study showed the following: “A total of 802 patients were randomly assigned to receive durvalumab (400 patients) or placebo (402 patients). The duration of event-free survival was significantly longer with durvalumab than with placebo; the stratified hazard ratio for disease progression, recurrence, or death was 0.68 (95% confidence interval [CI], 0.53 to 0.88; P = 0.004) at the first interim analysis. At the 12-month landmark analysis, event-free survival was observed in 73.4% of the patients who received durvalumab (95% CI, 67.9 to 78.1), as compared with 64.5% of the patients who received placebo (95% CI, 58.8 to 69.6). The incidence of pathological complete response was significantly greater with durvalumab than with placebo (17.2% vs. 4.3% at the final analysis; difference, 13.0 percentage points; 95% CI, 8.7 to 17.6; P <0.001 at interim analysis of data from 402 patients). Event-free survival and pathological complete response benefit were observed regardless of stage and PD-L1 expression. Adverse events of maximum grade 3 or 4 occurred in 42.4% of patients with durvalumab and in 43.2% with placebo. Data from 62 patients with documented EGFR or ALK alterations were excluded from the efficacy analyses in the modified intention-to-treat population.”

Source: New England Journal of Medicine