Penpulimab and Gemcitabine With or Without Anlotinib in Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter Phase 2 Study.
Shuang Huang, Ya-Qian Han, Kun-Yu Yang et al.
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In 30 seconds
This phase 2 randomized trial evaluated the efficacy and safety of anlotinib versus cisplatin in combination with gemcitabine and penpulimab for metastatic nasopharyngeal carcinoma (NPC) patients previously treated with cisplatin-based therapy. The study found that the gemcitabine, penpulimab, and anlotinib (GAP) regimen had an objective response rate of 93.3% and a median progression-free survival that was not reached at the time of analysis.
Key findings
- In the lead-in phase, grade ≥3 treatment-emergent adverse events occurred in 87.5% (GP-PA), 100% (GP-P), and 66.7% (GAP) patients.
- The objective response rate for the GAP regimen was 93.3% in the expansion phase.
- At median 20.2-month follow-up, median progression-free survival was 4.1 months for GP-PA, while it was not reached for GP-P and GAP.
- The 12-month progression-free survival and overall survival rates for the GAP regimen were 53.8% and 78.6%, respectively.
Why it matters
The findings suggest that substituting cisplatin with anlotinib in treatment regimens for metastatic nasopharyngeal carcinoma may improve patient outcomes, particularly in terms of response rates and safety profiles, which is crucial for optimizing treatment strategies in this challenging cancer.