In patients with advanced penile squamous cell carcinoma, pembrolizumab combined with platinum-based chemotherapy showed an overall response rate of 39.4%, with manageable toxic effects. The median overall survival was 9.6 months and median progression-free survival was 5.4 months.
Study
|
Phase 2 single-arm nonrandomized clinical trial [HERCULES (LACOG0218)] |
| Metastatic or locally advanced penile squamous cell carcinoma |
| Pembrolizumab + Platinum-based chemotherapy (n=37)
|
Efficacy
|
ORR: 39.4% [22.9-57.9] |
| mPFS: 5.4 mos [2.7-7.2] |
| mOS: 9.6 mos [6.4-13.2]
|
Safety
|
Grade >=3 AEs: 51.4% |
| Immune-related AEs grade >=3: 5.4% |
| Treatment-related deaths: 0%
|
JAMA Oncol. Published online September 18, 2025
http://doi.org/10.1001/jamaoncol.2025.3266
Reviewed by Ulas D. Bayraktar, MD on Oct 20, 2025
