Non-melanoma Skin Cancer
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May 18 – May 25, 2026
Phase 1/2 study of pegenzileukin, a pegylated recombinant non-alpha IL-2, with cemiplimab for the treatment of advanced unresectable or metastatic skin cancers.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase 1/2 open-label, multicenter clinical trial evaluated pegenzileukin, a pegylated non-alpha IL-2, in combination with cemiplimab for advanced melanoma (MM) and cutaneous squamous cell carcinoma (CSCC). The primary endpoint was objective response rate (ORR), which reached 40% in MM and 56.3% in CSCC at the recommended phase 2 dose (RP2D), with a duration of response ≥12 months in 75.0% and 85.7% of responders, respectively. Secondary endpoints included progression-free survival (PFS), with rates of 55.0% in MM and 70.7% in CSCC at 6 months. The treatment showed manageable safety, with common adverse events being mild infusion-related reactions and robust NK and CD8 T-cell expansion supporting its mechanism of action (NCT04913220).
10.1136/jitc-2025-014347
Apr 20 – Apr 27, 2026
Fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab: Tumor-specific expansion cohorts in advanced malignancies.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This phase 1 dose-expansion study evaluated fianlimab (anti-LAG-3) plus cemiplimab (anti-PD-1) in patients with advanced NSCLC, ccRCC, HNSCC, and CSCC. Patients received 1600 mg fianlimab plus 350 mg cemiplimab every 3 weeks for up to 24 months, with ORR per RECIST 1.1 as the primary endpoint. Investigator-assessed ORR was 27% in NSCLC-N, 7% in NSCLC-E, 20% in ccRCC-N, 7% in ccRCC-E, 33% in HNSCC-N, 7% in HNSCC-E, and 20% in CSCC-E. The combination demonstrated modest efficacy with acceptable safety, warranting further investigation.
10.1002/cncr.70396