First-line therapies for metastatic NSCLC win FDA approval

  • US Food and Drug Administration

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved 2 combination first-line therapies for metastatic NSCLC (mNSCLC):
    • Nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy for mNSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase mutations.
    • Ramucirumab (CYRAMZA, Eli Lilly and Company) plus erlotinib for mNSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations.

Why this matters

  • The FDA approved the nivolumab plus ipilimumab combination 2 months ahead of schedule.

Nivolumab plus ipilimumab

  • Approval based on CHECKMATE-9LA randomized trial:
    • Patients received combination therapy (n=361) or platinum-doublet chemotherapy for 4 cycles (n=358).
    • Median OS was significantly better with combination therapy (14.1 vs 10.7 months; HR, 0.69; 96.71% CI, 0.55-0.87).
    • Median response duration was 10 months with combination therapy vs 5.1 months with chemotherapy.
  • Most common adverse events (AEs) include fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
  • Recommended dose: nivolumab 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy.
  • View full prescribing information for OPDIVO.
  • View full prescribing information for YERVOY.

Ramucirumab plus erlotinib

  • Approval based on RELAY multinational, randomized, double-blind, placebo-controlled study:
    • 449 patients randomly assigned (1:1) to ramucirumab 10 mg/kg or placebo every 2 weeks as an intravenous infusion, with erlotinib 150 mg orally once daily.
    • Median PFS was significantly better in the ramucirumab group vs placebo (19.4 vs 12.4 months; HR, 0.59; P<.0001>
    • Median response duration was 18 months with ramucirumab vs 11.1 months with placebo.
  • Most common AEs include infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema.
  • Recommended dose of ramucirumab is 10 mg/kg every 2 weeks.
  • View full prescribing information for CYRAMZA.