Takeaway
- Nivolumab 480 mg every 4 weeks (Q4W) showed similar efficacy, safety to 240 mg every 2 weeks (Q2W) in patients with advanced NSCLC with disease control previously treated with nivolumab for 12 months or less.
Why this matters
- Supports nivolumab Q4W dosing schedule as a more convenient option for these patients.
Study design
- Phase 3b/4 CheckMate 384 trial randomly assigning patients with advanced NSCLC previously on nivolumab for 12 months, with >2 consecutive assessments of complete/partial response or stable disease 1:1 to nivolumab 480 mg Q4W or 240 mg Q2W until disease progression/unacceptable toxicity for up to 2 years.
- Coprimary endpoints: postrandomization PFS rates at 6, 12 months.
- Funding: Bristol-Myers Squibb.
Key results
- 329 patients enrolled as of 4/3/18.
- Median follow-up:
- 480 mg Q4W: 9.4 months.
- 240 mg Q2W: 10.2 months.
- Postrandomization 6-month PFS rates:
- 480 mg Q4W: 75% patients.
- 240 mg Q2W: 80% patients.
- Any-grade treatment-related adverse events:
- 480 mg Q4W: 48% patients.
- 240 mg Q2W: 61% patients.
Limitations
- Supposed to test noninferiority, but changes in landscape of first-line NSCLC treatment led to reduced sample size, insufficient power to confirm noninferiority.
- Short-term follow-up; 60% of patients reached 12-month follow-up.
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