Perioperative Durvalumab Added to Neoadjuvant Chemotherapy Increased Survival, Response Among Patients With Resectable Non-Small Cell Lung Cancer

According to results from a randomized study, adding perioperative durvalumab to neoadjuvant chemotherapy significantly increased event-free survival (EFS) and pathological complete-response (pCR) compared to chemotherapy alone among patients with resectable stage II to IIIB non-small cell lung cancer (NSCLC). 

“Neoadjuvant or adjuvant immunotherapy can improve outcomes in patients with resectable [NSCLC],” stated John V. Heymach, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, Texas, and coauthors. “Perioperative regimens may combine benefits of both to improve long-term outcomes.” 

In this study, 802 patients with resectable stage II to IIIB NSCLC were randomized to receive either platinum-based chemotherapy plus intravenous durvalumab (n = 400) or placebo (n = 402) every 3 weeks for 4 cycles followed by surgery and adjuvant durvalumab or placebo every 4 weeks for 12 cycles. Randomization was stratified based on disease stage and PD-L1) expression. Primary end points were EFS and pCR. 

At the time of the first interim analysis, the duration of EFS was significantly longer in the durvalumab arm than in the placebo arm, with a stratified hazard ratio (HR) for disease progression, recurrence, or death of 0.68 (95% confidence interval [CI], 0.53 to 0.88; P = .004). At the 12-month landmark analysis, EFS was observed in 73.4% of patients in the durvalumab arm and 64.5% of patients in the placebo arm. The incidence of pCR was 17.2% in the durvalumab arm and 4.3% in the placebo arm (P < .001). EFS and pCR benefit was observed regardless of disease stage and PD-L1 expression. Grade 3/4 adverse events occurred in 42.4% of patients in the durvalumab arm and 43.2% of patients in the placebo arm. 

As Dr Heymach and coauthors concluded, “in patients with resectable NSCLC, perioperative durvalumab plus neoadjuvant chemotherapy was associated with significantly greater event-free survival and pathological complete response than neoadjuvant chemotherapy alone, with a safety profile that was consistent with the individual agents.” 

Source: 

Heymach JV, Harpole D, Mitsudomi T, et al. Perioperative durvalumab for resectable non–small-cell lung cancer. N Engl J Med. Published online: November 2, 2023. doi:10.1056/NEJMoa2304875