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A-290 - Efficacy and safety of RP1 plus nivolumab in patients with non-melanoma skin cancer
Abstract   Open access   Peer reviewed

A-290 - Efficacy and safety of RP1 plus nivolumab in patients with non-melanoma skin cancer

D. Schadendorf, M.K. Wong, G.M. Beasley, A.C. Pavlick, K.J. Harrington, B. Chmielowski, J. Niu, A.M. VanderWalde, T.L. Bowles, K.K. Tsai, …
EJC skin cancer, Vol.4(Supplement 1), 100982
2026
DOI: 10.1016/j.ejcskn.2026.100982
url
https://doi.org/10.1016/j.ejcskn.2026.100982View
Published (Version of record) Open Access

Abstract

Background: Patients with non-melanoma skin cancer (NMSC) that has progressed on an anti–PD-(L)1–containing therapy have poor clinical outcomes and limited treatment options. RP1 (vusolimogene oderparepvec) is an oncolytic immunotherapy that expresses human granulocyte-macrophage colony-stimulating factor and a fusogenic glycoprotein (GALV-GP-R−). Here, we report the efficacy of RP1 + nivolumab from the NMSC cohort of the phase 1/2 IGNYTE trial (NCT03767348). Methods: The trial enrolled patients with anti–PD-1–naïve and–failed NMSC, including Merkel cell carcinoma (MCC), basal cell carcinoma (BCC), angiosarcoma, and cutaneous squamous cell carcinoma (CSCC). RP1 was administered intratumorally, at 1×106 PFU/mL initially, then at 1×107 PFU/mL every 2 weeks (Q2W; ≤7 doses) with intravenous nivolumab. The objective response rate was assessed by investigator assessment using modified RECIST; the key modification was that progression had to be confirmed by further tumor increase to allow for the potential of pseudoprogression. Results: At data cutoff (11JUN2025), 118 patients with NMSC were included; 73% of patients had disease progression on prior anti–PD-1 therapy. Substantial responses to RP1 + nivolumab occurred across tumor types (MCC, BCC, angiosarcoma, and CSCC), with confirmed responses seen both in patients with anti–PD-1–naïve and anti–PD-1–failed disease (Table). The most common treatment-related adverse events (TRAEs; ≥15%) were fatigue, chills, and pyrexia. The most common grade ≥3 TRAEs (reported in ≥2 patients overall) were fatigue, rash maculo-papular, and diarrhea. Conclusions: RP1 + nivolumab induced responses across multiple NMSC tumor types, including anti–PD-1–failed disease, and represents a promising treatment approach for patients with advanced skin cancers, including those with disease progression on prior anti–PD-1 therapy.

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