Trial reportJournal for immunotherapy of cancer2026
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.
Trial report in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04913220 (A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers
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13 authors.
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Abstract
backgroundPegenzileukin (SAR444245), a pegylated non-alpha recombinant human interleukin (IL)-2 variant, avoids engagement of the IL-2 receptor α subunit (IL-2Rα) chain and associated toxicities, while retaining engagement of IL-2Rβγ, for activation of effector T cell and natural killer (NK) cell. The first-in-human study of pegenzileukin with pembrolizumab showed initial efficacy and tolerable safety in advanced and metastatic solid tumors. In this study, we evaluate pegenzileukin with cemiplimab for advanced or metastatic melanoma (MM) and cutaneous squamous cell carcinoma (CSCC).
methodsThis phase 1/2, open-label, multicenter study evaluated drug combinations in patients with MM (Cohort A) and CSCC (Cohort B). Pegenzileukin was given at two dose levels (16 µg/kg: Cohort A1 and B1 and 24 µg/kg: Cohort A2 and B2) during dose escalation and recommended phase 2 dose (RP2D) during dose expansion, while cemiplimab was given at a dose of 350 mg; both drugs were administered every 3 weeks as a 30-minute intravenous infusion. The primary endpoint was the objective response rate (ORR); secondary endpoints included dose-limiting toxicities (DLTs), progression-free survival (PFS), safety, and exploratory biomarker endpoints.
resultsA total of 46 patients were enrolled. At the RP2D of pegenzileukin (16 µg/kg, n=20 in Cohort A1 and n=16 in Cohort B1), the ORR was 40% in Cohort A1 and 56.3% in Cohort B1. In Cohort A1, one patient achieved a complete response, and seven achieved a partial response (PR). In Cohort B1, nine patients achieved a PR. At the RP2D, 75.0% and 85.7% responders, respectively, in Cohort A1 and Cohort B1 had a duration of response of ≥12 months. The PFS rate at 6 months was 55.0% in Cohort A1 and 70.7% in Cohort B1. Five DLTs occurred in four patients: Cohort A had one case of ≥3 Grade thrombocytopenia and one of Grade 2 cytokine release syndrome, while Cohort B had one case of ≥3 Grade alanine transaminase/aspartate transaminase increases and one infusion-related reaction (IRR). Grade 1 or 2 IRRs were the most common adverse events. Treatment led to robust expansion of NK and CD8 T-cells, without an increase of regulatory T cells.
conclusionPegenzileukin in combination with cemiplimab at the RP2D of 16 µg/kg showed a manageable safety profile and promising translational data supporting its mechanism of action. TRIAL REGISTRATION NUMBER: NCT04913220.
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