Perioperative chemotherapy plus nivolumab outperforms perioperative chemotherapy alone in patients with resectable non-small cell lung cancer.

In patients with resectable NSCLC, neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival (EFS) and a higher percentage of patients with a pathological complete response than chemotherapy alone.¹ The phase 2 study CheckMate 816 (NCT02998528) showed further improvement with a perioperative approach including adjuvant nivolumab.² The current phase 3 CheckMate 77T trial (NCT04025879) is the first study to explore the efficacy and safety of this perioperative approach in patients with resectable stage II-IIIB NSCLC. Dr. Tina Cascone of MD Anderson Cancer Center, Houston, presented the results from the pre-specified interim analysis.³

CheckMate 77T enrolled 416 participants with resectable NSCLC (stage IIA-IIIB, without EGFR mutation or ALK rearrangement) who had no prior systemic anti-cancer treatment. Patients were randomized 1:1 to perioperative nivolumab plus chemotherapy or placebo plus chemotherapy (4 cycles neoadjuvant therapy, followed by surgery and 1-year adjuvant therapy). Of all enrolled participants, 78% underwent surgery, 62%-66% received adjuvant therapy, and 60% completed adjuvant therapy.

At a median follow-up of 25 months, EFS, the primary endpoint of the study, was in favor of the nivolumab-treated arm: not reached (NR; 95% CI, 28.9 months-NR) versus 18.4 months (95% CI, 13.6-28.1 months) for the placebo arm (HR, 0.58; 95% CI, 0.42-0.81; P=.00025). EFS rates at 18 months were 70% and 50% in the nivolumab and placebo arm, respectively. EFS benefit for nivolumab was observed across subgroups, including PD-L1 status. In addition, pCR was improved in the nivolumab arm (25.3% vs 4.7%; odds ratio, 6.64; 95% CI, 3.40-12.97). Perioperative nivolumab increased EFS regardless of pCR status. No new safety issues were observed.

Dr. Cascone concluded: “These interim results support perioperative nivolumab as a potential new treatment option for patients with resectable NSCLC.” However, the study did not yet report whether there is an additional benefit of adjuvant nivolumab in patients who have a pCR after neoadjuvant nivolumab, as discussant Dr. Marina Garassino of the Instituto Nationale dei Tumori, Milan, remarked.

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