Efficacy and Safety of Necitumumab and Pembrolizumab Combination Therapy in Advanced Non-Small Cell Lung Cancer with ≥50% PD-L1 Expression: A Nonrandomized Phase II Trial.
Atsushi Horiike, Hiroshi Wakui, Shunichi Sugawara et al.
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In 30 seconds
This nonrandomized, multicenter, open-label, single-arm phase II trial evaluated first-line pembrolizumab plus necitumumab in 50 patients with previously untreated advanced NSCLC and PD-L1 tumor proportion score ≥50%. The investigator-assessed objective response rate was 76% (95% confidence interval, 61.9-86.9; P < 0.0001), including 2% complete and 74% partial responses. Median progression-free survival was 15.7 months; median overall survival had not been reached at analysis. Rash and hypomagnesemia were common treatment-related adverse events, and serious pulmonary and cardiac events occurred.
Key findings
- Objective response rate was 76% (95% confidence interval, 61.9-86.9; P < 0.0001), with complete and partial response rates of 2% and 74%.
- Median progression-free survival was 15.7 months; median overall survival was not reached at the time of analysis.
- Rash occurred in 64% and hypomagnesemia in 60%; grade 3 interstitial lung disease occurred in five patients (10%), and grade 5 cardiac arrest in one (2%).
Why it matters
The response rate and progression-free survival provide a signal of activity for combining necitumumab with pembrolizumab in advanced NSCLC with high PD-L1 expression. However, the observed severe interstitial lung disease and fatal cardiac arrest underscore that efficacy must be considered alongside potentially serious toxicity. The findings add evidence for further evaluation, rather than establishing comparative benefit.
What to keep in mind
The trial was single-arm and nonrandomized, so it cannot establish comparative efficacy or attribute outcomes to the combination versus either agent alone.