1Gustave Roussy and Paris-Saclay University, Villejuif, France; 2The Clatterbridge Cancer Centre, Wirral, UK, and University of Liverpool, Liverpool, UK; 3Vall d'Hebron Institute of Oncology (VHIO) and Vall d'Hebron Hospital Medical Oncology Department, Barcelona, Spain; 4Department 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; 5University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA; 6Duke Cancer Institute, Duke University, Durham, NC, USA; 7Banner MD Anderson Cancer Center, Gilbert, AZ, USA; 8Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA; 9University of Cincinnati Cancer Center, University of Cincinnati, Cincinnati, OH, USA; 10Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA; 11Intermountain Medical Center, Murray, UT, USA; 12Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA; 13Université Paris Cité, AP-HP Dermato-Oncology and CIC, Cancer Institute APHP. Nord-Université Paris Cité, INSERM U976, Saint Louis Hospital, Paris, France; 14Aix-Marseille Université, APHM, Centre de Recherche en Cancérologie de Marseille (CRCM), INSERM, U1068, CNRS, UMR7258, UM105, Hôpital Timone, CEPCM, Dermatology and Skin Cancer Department, Marseille, France; 15Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK; 16Replimune, Inc., Woburn, MA, USA; 17Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA
Table 1. Baseline demographics and clinical characteristics of patients with acral melanoma
CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease.
Unique prior regimens for advanced/metastatic disease
Treatment ongoing Long-term follow-up Study ongoing
aPrimary resistance: progressed within 6 months of starting the immediate prior course of anti-PD-1 therapy.
bSecondary resistance: progressed after 6 months of starting the immediate prior course of anti-PD-1 therapy.
CTLA-4, cytotoxic T-lymphocyte antigen 4; LDH, lactate dehydrogenase; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; ULN, upper limit of normal.
CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.
PD-1, programmed cell death protein 1; TRAE, treatment-related adverse event.
Tumor response assessment: Radiographic imaging at baseline, every 8 weeks from first dose, and every 12 weeks after confirmation of response
Anti-PD-1-failed advanced melanoma (including acral), measurable disease, adequate organ function, no prior oncolytic therapy, ECOG performance status 0-1
Criteria for prior anti-PD-1 failure
Confirmed progression while being treated with at least 8 weeks of anti-PD-1 therapy, alone or in combination; anti-PD-1 must be the last prior therapy. Patients on prior adjuvant therapy must have confirmed progression while being treated withadjuvant treatment (PD can be confirmed by biopsy)
Primary analysis was conducted when all patients had
aAdditional doses of RP1 can be given beyond 8 cycles if protocol-specified criteria are 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.
CR, complete response; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; mRECIST, modified RECIST 1.1; ORR, objective response rate; OS, overall survival; PD, progressive disease; PD-1, programmed cell death protein 1; PFS, progression-free survival; PFU, plaque-forming units; Q4W, every 4 weeks; RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1.
ORR (CR + PR) 8 (44.4)
Data were centrally reviewed by RECIST 1.1 (per protocol).
BICR, blinded independent central review; BOR, best overall response; CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SD, stable disease.
(A) Tumor responses in non-injected lower leg, leg skin, and foot lesions from a patient with injection to a lower leg tumor. (B) Tumor response in a patient with injected and non-injected lung lesions.
The IGNYTE study is currently recruiting patients. 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, as well as Chris Tucci and Tim Liu from Replimune, Inc. Medical writing and editorial support were provided by Claire Strothman, PhD, of Red Nucleus, and were funded by Replimune, Inc.
This study is sponsored by Replimune, Inc. (Woburn, MA). Nivolumab was supplied by Bristol Myers Squibb.
Additional information can be obtained by visiting ClinicalTrials.gov (NCT03767348).
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