SCLC: no survival benefit with nivolumab plus ipilimumab

  • Ready NE & al.
  • J Thorac Oncol
  • 17 Oct 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Although nivolumab plus ipilimumab offered better objective response rates (ORRs) as second- or third-line treatment for SCLC compared with nivolumab alone, the combined therapy had higher toxicity and did not offer better PFS or OS than monotherapy.

Why this matters

  • These data offer longer-term results than previously reported preliminary results, which only offered 3-month outcomes.

Study design

  • Long-term data on the randomized cohort of the multicenter, open-label, phase 1/2 CheckMate 032 trial.
  • Patients with SCLC disease progression after 1-2 prior chemotherapy regimens received nivolumab plus ipilimumab (n=96) or nivolumab alone (n=147).
  • Minimum follow-up for ORR/PFS/safety was 11.9 months (nivolumab) and 11.2 months (combination therapy), and for OS it was 29.0 months (nivolumab) and 28.4 months (combination therapy).
  • Funding: Bristol-Myers Squibb; ONO Pharmaceutical Company Ltd.

Key results

  • Overall response rate was significantly better with combination therapy (21.9% vs 11.6%; OR, 2.12; P=.03).
  • Median PFS was similar between groups (1.4 months with nivolumab vs 1.5 months with nivolumab plus ipilimumab).
  • 12- and 24-month OS rates were similar between groups, with 30.5% and 17.9% for monotherapy vs 30.2% and 16.9% for the combined therapy.
  • Grade 3-4 treatment-related adverse events were more common in the combination therapy group (37.5% vs 12.9%).

Limitations

  • None included.