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FDA Approves Nivolumab/Ipilimumab Plus Chemotherapy for First-Line Treatment of Metastatic or Recurrent NSCLC


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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.

CheckMate-9LA

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.


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