EPIC-A Trial Insights on Cemiplimab and Chemotherapy in Penile Carcinoma

Amarnath Challapalli, MBBS, MD, MRCP, FRCR, PhD, consultant clinical oncologist at Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, discusses some of the most promising findings from the EPIC-A trial (ISRCTN95561634) regarding the combination of cemiplimab-rwlc (Libtayo) and chemotherapy in treating locally advanced or metastatic penile carcinoma, and how might this impact future treatment options for this rare cancer.

According to data from the phase 2 EPIC trial presented at the 2025 ASCO Genitourinary Cancer Symposium, cemiplimab combined with standard platinum-based chemotherapy demonstrated positive efficacy and a safety profile consistent with prior reports in patients with locally advanced or metastatic penile carcinoma.

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0:10 | So, I think what is important is that in patients who are fit enough to have treatment, then we should potentially be thinking about the combination treatment when, of course, it is mindful that this is not a randomized, control trial, but inherent to the rare diseases, we are unable to get random phase 3 randomized trial evidence. And I think the phase 2 trial is significant enough to think about potentially whether there is benefit of the combination. And I think that would potentially be what people should be thinking about, is if the patient is fit and if they want to give them good outcomes, potentially, one should consider the cemiplimab combination with chemotherapy.

0:54 | Of course, the other point also to think about is how, what, what view the regulatory authorities would take, and whether this would be reimbursable. But certainly, this is something we will be working on locally as well.

REFERENCE:

Bahl A, Challapalli A, Venugopal B, et al. EPIC-A: phase II trial of cemiplimab plus standard of care chemotherapy followed by maintenance cemiplimab in locally advanced or metastatic penile carcinoma. J Clin Oncol. 2025;43(suppl 5):1. doi:10.1200/JCO.2025.43.5_suppl.1