Abstract
1661P Efficacy and safety of RP1 + nivolumab (nivo) in patients with non-melanoma skin cancer (NMSC)
Annals of oncology, Vol.36, pp.S983-S984
09/2025
DOI: 10.1016/j.annonc.2025.08.2289
Abstract
Background
Patients (pts) with 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 + nivo from the NMSC cohort of the phase 1/2 IGNYTE trial (NCT03767348).
Methods
The trial enrolled pts 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 Q2W (≤7 doses) with intravenous nivo. The objective response rate (ORR) was assessed by investigator assessment using modified RECIST (mRECIST); the key modification was that progression had to be confirmed by further tumor increase to allow for the potential of pseudoprogression.
Results
A total of 99 pts with NMSC were evaluable for efficacy; 71% of pts overall had disease progression on prior anti–PD-1 therapy. Substantial responses to RP1 + nivo occurred across tumor types (MCC, BCC, angiosarcoma), with confirmed responses seen both in pts with anti–PD-1–naïve and –failed disease, as well as in locally advanced (LA) and metastatic (met) CSCC (Table). The most common treatment-related adverse events (TRAEs; ≥15%) were fatigue, chills, and pyrexia. The most common grade ≥3 TRAEs (≥2 events in pts with anti–PD-1–naïve or –failed disease) were fatigue, rash maculo-papular, abdominal pain, diarrhea, hyponatremia, and pyrexia.
Details
- Title: Subtitle
- 1661P Efficacy and safety of RP1 + nivolumab (nivo) in patients with non-melanoma skin cancer (NMSC)
- Creators
- D. Schadendorf - University of Duisburg-EssenM.K. Wong - Roswell Park Comprehensive Cancer CenterG.M. Beasley - Duke UniversityA.C. Pavlick - Weill Cornell MedicineK.J. Harrington - NIHR Biomedical Research Centre at The Royal Marsden and the ICRB. Chmielowski - University of California, Los AngelesJ.J. Niu - Banner MD Anderson Cancer CenterA.M. VanderWalde - West Cancer CenterT.L. Bowles - Intermountain Medical CenterK.K. Tsai - University of California, San FranciscoE.T. Hall - University of Washington School of MedicineT.M. Wise-draper - University of CincinnatiJ. Michels - Institut Gustave RoussyA.M. Arance - Medical Oncology Department, Hospital Clinic, Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, SpainM. Amini Adle - Centre Léon BérardJ. Zhu - Biometrics, Replimune, Inc., Woburn, United States of AmericaM. Viana - Clinical Development, Replimune, Inc., Woburn, United States of AmericaJ.W. Hou - Clinical Development, Replimune, Inc., Woburn, United States of AmericaM.M. Milhem - University of Iowa
- Resource Type
- Abstract
- Publication Details
- Annals of oncology, Vol.36, pp.S983-S984
- DOI
- 10.1016/j.annonc.2025.08.2289
- ISSN
- 0923-7534
- eISSN
- 1569-8041
- Publisher
- Elsevier Ltd
- Grant note
- Replimune, Inc.
Replimune, Inc.
- Language
- English
- Date published
- 09/2025
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9985035039202771
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