There were no new safety signals with cemiplimab plus chemotherapy in the phase 2 EPIC-A trial, Challapalli stated.
Amarnath Challapalli, MBBS, MD, MRCP-UK, FRCR, PhD, a consultant clinical oncologist at Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, spoke with CancerNetwork® at the 2025 ASCO Genitourinary Cancer Symposium about the phase 2 EPIC-A trial (ISRCTN95561634).
The EPIC-A trial is currently evaluating first-line treatment with cemiplimab-rwlc (Libtayo) added to chemotherapy followed by maintenance cemiplimab in patients with locally advanced or metastatic penile carcinoma.
There are future plans to conduct a thorough quality of life analysis, although as there are still patients receiving treatment, it cannot yet be completed. He added that, in general, quality of life is linked to disease progression and that the most recent analysis was focused on clinical benefit. The trial showed a median progression-free survival of 6.2 months (95% CI, 3.7-8.7).
Challapalli, when questioned about sequencing the combination, noted that many patients with penile carcinoma don’t survive until the second line of treatment, so any possible sequencing options would need to be viable first-line treatments.
Transcript:
We are still in the process of looking at [quality of life], [although] we did do a quality of life analysis. Obviously, here, we were focusing on the primary end point of the clinical benefit rate, but we’ll be looking at [quality of life] closely—there are a couple of patients who are still on treatment. Once we look at that, we will definitely report on it. But generally, in patients, the quality of life is determined by if the patients have progressed; they do tend to have worse quality of life [if they progress]. In terms of tolerability, as we have seen, there were no new safety signals. We would hope that it will stack up with what is known in literature, but we’ll definitely watch the space.
What is important here is that a significant proportion of patients with advanced penile cancer don’t live [long enough] to get to second-line treatment, so it is important to use a combination that works as a first-line treatment. Here, we are still not talking about sequencing because we’re using the combination of chemotherapy plus immunotherapy. Hopefully, that would allow more patients to benefit from this.
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