1Department of Dermatology, West German Cancer Center, University Hospital Essen & National Center for Tumor Diseases (NCT-West), Campus Essen & University Alliance Ruhr, Research Alliance Ruhr, Research Center One Health, University Duisburg-Essen, Campus Essen, Essen, Germany; 2Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA; 3Duke Cancer Institute, Duke University, Durham, NC, USA; 4Weill Cornell Medical College, New York, NY, USA; 5The Institute of Cancer Research/Royal Marsden NIHR Biomedical Research Centre, London, UK; 6Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA; 7Banner MD Anderson Cancer Center, Gilbert, AZ, USA; 8West Cancer Center and Research Institute, Germantown, TN, USA; 9Intermountain Medical Center, Murray, UT, USA; 10Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA;
11Fred Hutchinson Cancer Center, University of Washington School of Medicine, Seattle, WA, USA; 12University of Cincinnati Cancer Center, University of Cincinnati, Cincinnati, OH, USA; 13Département de Médecine Oncologique, Gustave Roussy, Villejuif, France; 14Medical Oncology Department, Hospital Clinic, Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain; 15Centre Léon Bérard, Lyon, France; 16Replimune, Inc., Woburn, MA, USA;
17Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA
To report the efficacy and safety of RP1 plus nivolumab in the NMSC cohort from the IGNYTE trial
Tumor response assessment: Radiographic imaging at baseline and every 8 weeks from first dose and every 12 weeks after confirmation of response
Advanced NMSCc considered not treatable with surgical excision; measurable disease; adequate organ function; no prior oncolytic therapy; ECOG performance status 0-1
Patients with anti-PD-1-naïve NMSC for whom anti-PD-1 is indicated, or for whom currently available therapies are not appropriate
Patients with anti-PD-1-failed NMSC whose disease progressed while being treated with at least 8 weeks of anti-PD-1 therapy; anti-PD-1 must be the last prior therapy
aRP1 could be reinitiated beyond 8 cycles if protocol-specified criteria were met.
bFor mRECIST, PD must be confirmed by further progression at least 4 weeks after initial PD; intended to better allow for pseudoprogression than RECIST 1.1. cNMSC includes basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma, high-grade dermatofibrosarcoma protuberans, angiosarcoma of the skin, non-HIV-related Kaposi's sarcoma, sebaceous gland carcinoma, and eccrine carcinomas.
ECOG, Eastern Cooperative Oncology Group; HIV, human immunodeficiency virus; mRECIST, modified RECIST 1.1; NMSC, non-melanoma skin cancer; PD, progressive disease; PD-1, programmed cell death protein 1; PFU, plaque-forming units; Q4W, every 4 weeks; RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1.
aThe ORR for efficacy-evaluable patients is shown; ORR based on the full analysis set including all patients is identical except for anti-PD-1-naïve MCC (66.7% [4/6]), anti-PD-1-failed MCC (22.7% [5/22]), and anti-PD-1-naïve BCC (25.0% [1/4]).
BCC, basal cell carcinoma; BOR, best overall response; CR, complete response; CSCC, cutaneous squamous cell carcinoma; LA, locally advanced; MCC, Merkel cell carcinoma; Met, metastatic; NE, not evaluable; NMSC, non-melanoma skin cancer; ORR, objective response rate; PD, progressive disease; PD-1, programmed cell death protein 1; PR, partial response; SD, stable disease.
MCC, Merkel cell carcinoma; PD-1, programmed cell death protein 1.
Injected
aThe safety population includes additional patients with other NMSC subtypes (basosquamous carcinoma [n = 2], non-HIV-related Kaposi's sarcoma [n = 2], sebaceous gland carcinoma [n = 2], eccrine carcinomas [n = 3], and missing [n = 1]).
HIV, human immunodeficiency virus; NMSC, non-melanoma skin cancer; PD-1, programmed cell death protein 1; TRAE, treatment-related adverse event.
missing
BCC, basal cell carcinoma; CSCC, cutaneous squamous cell carcinoma; ECOG, Eastern Cooperative Oncology Group; MCC, Merkel cell carcinoma; NMSC, non-melanoma skin cancer; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1.
BCC, basal cell carcinoma; CR, complete response; CSCC, cutaneous squamous cell carcinoma; MCC, Merkel cell carcinoma; NE, not evaluable; PD, progressive disease; PD-1, programmed cell death protein 1; PR, partial response; SD, stable disease.
The IGNYTE study is currently continuing to recruit patients with NMSC. To learn more about enrolling your patient, contact [email protected] or +1 (781) 222 9570.
Acknowledgments:
The authors would like to thank the patients and their families for their participation in the trial. Medical writing and editorial support were provided by June F. Yang, PhD, of Red Nucleus, and were funded by Replimune, Inc.
Copies of this poster obtained through QR, AR, and/or text key codes are for personal use only and may not be reproduced without written permission of the authors.
Additional information can be obtained by visiting ClinicalTrials.gov (NCT03767348).
Study sponsor: