Nivolumab plus ipilimumab for mNSCLC wins FDA approval


  • Kelli Whitlock Burton
  • Oncology drug update
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Takeaway

  • The FDA has approved combination therapy with nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) for firstline treatment of metastatic NSCLC (mNSCLC) with programmed death-ligand 1 (PD-L1) expression ≥1% and no epidermal growth factor receptor or anaplastic lymphoma kinase mutations.

Why this matters

  • The combination therapy received priority review status from the FDA, with a Prescription Drug User Fee Act goal date of August 6, 2020 and Fast Track designation.

Key points

  • PD-L1 expression determined by an FDA-approved test.
  • Recommended dosage: nivolumab 3 mg/kg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.
  • Approval based on randomized, open-label CHECKMATE-227 trial of 793 patients with untreated metastatic or recurrent NSCLC and PD-L1 ≥1% treated with combination therapy or platinum-doublet chemotherapy:
    • Median OS with combination therapy vs platinum-doublet chemotherapy:
      • 17.1 months vs 14.9 months;
      • HR, 0.79 (P=.0066).
    • Median response duration:
      • 23.2 months vs 6.2 months.
  • Most common adverse events included fatigue, rash, decreased appetite, musculoskeletal pain, diarrhea/colitis, dyspnea, cough, pruritus, nausea, and hepatitis.

Prescribing information for OPDIVO

Prescribing information for YERVOY