On May 26, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Efficacy was investigated in CheckMate-9LA, a randomized, open-label trial in patients with metastatic or recurrent NSCLC. Patients were randomly assigned to receive either the combination of nivolumab plus ipilimumab and two cycles of platinum doublet chemotherapy (n = 361) or platinum doublet chemotherapy for four cycles (n = 358).
The trial demonstrated a statistically significant benefit in overall survival for patients treated with nivolumab/ipilimumab plus chemotherapy vs those who received chemotherapy alone. Median overall survival was 14.1 months (95% confidence interval [CI] = 13.2–16.2) vs 10.7 months (95% CI = 9.5–12.5), yielding a hazard ratio (HR) of 0.69 (96.71% CI = 0.55–0.87).
Median progression-free survival per blinded independent central review was 6.8 months (95% CI = 5.6–7.7) in the nivolumab/ipilimumab–plus-chemotherapy arm and 5 months (95% CI = 4.3–5.6) in the chemotherapy–alone arm (HR = 0.70; 95% CI = 0.57–0.86). Confirmed overall response rate per blinded independent central review was 38% (95% CI = 33%–43%) and 25% (95% CI = 21%–30%), respectively. Median response duration was 10 months in the nivolumab/ipilimumab–plus-chemotherapy arm and 5.1 months in the chemotherapy–alone arm.
The most common adverse reactions in ≥ 20% of patients receiving nivolumab/ipilimumab plus platinum-doublet chemotherapy were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
The recommended nivolumab dose for this indication is 360 mg every 3 weeks with ipilimumab at 1 mg/kg every 6 weeks and two cycles of platinum-doublet chemotherapy. Nivolumab and ipilimumab are continued until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.