(UroToday.com) The 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Annual Symposium held in San Francisco, CA was host to a rapid oral abstract session. Dr. Amit Bahl presented EPIC-A, a phase II trial of cemiplimab plus standard of care chemotherapy followed by maintenance cemiplimab in locally advanced or metastatic penile carcinoma.
Platinum-based combination chemotherapy remains the standard of care (SoC) treatment for patients with locally advanced/metastatic penile cancer (la/mPC). The prognosis is poor, and treatment options are limited. PD-L1 is upregulated in 40–60% of cases, providing a rationale for evaluating immunotherapy as a treatment option for la/mPC. The PD-1 inhibitor cemiplimab is approved for patients with locally advanced or metastatic cutaneous SCC. Dr. Bahl and colleagues evaluated the efficacy and safety of cemiplimab in combination with SoC chemotherapy in patients with la/mPC.
EPIC-A was a non-randomized, open label, phase II, multicenter trial. It included patients with:
- la/mPC, defined as: TxN3M0 or TxN2M0 or T3N1M0 or T4anyN or M1
- No prior chemotherapy for treatment of penile cancer
- Histologically-proven squamous cell carcinoma of the penis or penile urethra
- ECOG performance status 0–2
- Adequate renal, liver, and bone marrow function
- Measurable disease as per RECIST 1.1
Eligible patients received 4 cycles of cisplatin-based chemotherapy (cisplatin + 5-FU or cisplatin, etoposide, paclitaxel [TIP]) + IV every 3 weeks plus cemiplimab 350 mg IV for a total of two years. The primary endpoint was investigator-assessed clinical benefit rate at 12 weeks. Secondary outcomes were:
- Safety
- CBR at 1, 2, 3 years
- Overall response rate (ORR)
- Progression Free survival (PFS)
- Overall survival (OS)
- Quality of Life (QoL)
The baseline patient characteristics are summarized in the table below (n=29). The median age was 61 years. 24% had locally advanced disease, and 76% were metastatic. The most common site of metastasis was the lung (55.2%), followed by bone (23%) and liver (7%). The median number of cycles administered was 5, and patients were followed-up for a median of 15 months
At 12 weeks, the CBR was 62%. A partial response was observed in 15 (52%) patients and stable disease in 3 (10.3%). At 21 weeks, the CBR decreased to 48.3%, although there was one CR observed.
The median PFS and OS were 6.2 and 15.5 months.
The Swimmer’s plot for duration of response is illustrated below:
The safety profile is in keeping with reported data on cisplatin-based chemotherapy and cemiplimab. 23% of adverse events were related to cemiplimab, and 31% were related to chemotherapy. There were two grade 5 AEs, neither related to cemiplimab, but 1 related to chemotherapy. 7 patients discontinued treatment, of which 4 were related to cemiplimab (14%).
Dr. Bahl concluded as follows:
- The EPIC-A trial provides important data regarding the efficacy and safety of cemiplimab in combination with platinum-based chemotherapy as a treatment for la/mPC
- The trial met its primary endpoint with CBR of 62.1% at 12 weeks
- Median PFS was 6.2 months, and median OS was 15.5 months
- No new safety signals were identified
- These data support combination cisplatin-based chemotherapy + cemiplimab as a first line treatment option to potentially improve outcomes in this rare cancer
Presented by: Amit Bahl, MBBS, MD, DNB, FRCP, FRCR, FFRRCSI, Professor, Consultant Clinical Oncologist, Bristol Cancer Institute, University Hospitals Bristol, UK
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025.