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.

What was studied

This trial tested pegenzileukin with cemiplimab. Pegenzileukin is an IL-2 variant. It avoids the IL-2 receptor α chain, to avoid linked toxicities. Patients had advanced or metastatic melanoma or cutaneous squamous cell carcinoma. It was a phase 1/2, open-label, multicenter study. Doses were 16 µg/kg and 24 µg/kg during escalation. The main outcome was objective response rate. 46 patients were enrolled. At the 16 µg/kg dose, 20 had melanoma and 16 had squamous cell cancer.

What they found

Response rates were 40 for melanoma and 56.3 for squamous cell cancer. These are rates, not patient counts. Most responses lasted 12 months or more. The rates were 75.0 and 85.7 among responders. Progression-free survival rates at 6 months were 55.0 and 70.7. Some patients had dose-limiting toxicities. These included low platelets, cytokine release syndrome, raised liver enzymes and an infusion reaction. Grade 1 or 2 infusion reactions were the most common events. NK and CD8 T cells expanded. Regulatory T cells did not increase.

What it means for patients

The authors say the combination had a manageable safety profile at 16 µg/kg. They say the translational data support how the drug works.

Why it is not certain yet

This was an early-phase, open-label study. Each cohort was small. Results at the 24 µg/kg dose are not given. Survival is given only at 6 months.

Source

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.

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