Tudriqev (vusolimogene oderparepvec-wtpg) / Replimune - LARVOL DELTA

RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE). (PubMed, J Clin Oncol) - P2 | "RP1 combined with nivolumab provided deep and durable systemic responses in patients with anti-PD-1-failed melanoma, including those with poor prognostic factors. The safety profile was favorable, with mostly grade 1/2 adverse events. (Funded by Replimune, Inc.; IGNYTE ClinicalTrials.gov, NCT03767348; EudraCT number, 2016-004548-12)."

IO biomarker • Journal • Melanoma • Oncology • Solid Tumor • CD8

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Replimune Inc. | Phase classification: P1/2 ➔ P2 | Trial completion date: Dec 2021 ➔ Nov 2024 | Trial primary completion date: Nov 2021 ➔ Nov 2024

Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF • MSI

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: Replimune Inc. | Trial completion date: Nov 2024 ➔ Jun 2025 | Trial primary completion date: Nov 2024 ➔ Jun 2025

Monotherapy • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF • MSI

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov) - P2 | N=340 | Active, not recruiting | Sponsor: Replimune Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF • MSI

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov) - P1/2 | N=168 | Recruiting | Sponsor: Replimune Inc.

Monotherapy • New P1/2 trial • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF • MSI

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov) - P1/2 | N=281 | Recruiting | Sponsor: Replimune Inc. | N=168 ➔ 281

Enrollment change • Monotherapy • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF • MSI

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: Replimune Inc. | Trial completion date: Jun 2025 ➔ Dec 2028 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Monotherapy • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF • MSI

Response Analysis for Injected and Non-injected Lesions and of the Safety and Efficacy of Superficial and Deep/Visceral RP1 Injection in the Registrational Cohort of Anti–PD-1–failed Melanoma Patients of the IGNYTE Trial (SIO 2026) - P2 | "Purpose: The IGNYTE trial (NCT03767348) primary analysis of RP1 (vusolimogene oderparepvec) plus nivolumab (nivo) showed clinically meaningful durable efficacy (objective response rate [ORR], 32.9%; median duration of response, 33.7 months, by Response Evaluation Criteria in Solid Tumors version 1.1. Meaningful systemic responses occurred independent of lesion injection status or anatomical sites. Thus, overall response was driven by both injected and noninjected lesion responses. The safety and efficacy profiles of deep/visceral vs superficial injections were generally comparable, though response rates were numerically higher after deep/visceral injections vs superficial injections only."

Clinical • Infectious Disease • Influenza • Melanoma • Respiratory Diseases • Solid Tumor

Effects of oncolytic immunotherapy with RP1 (vusolimogene oderparepvec) on immune cells mediate responsiveness to anti-PD-1 via STING-mediated interferon signaling. (PubMed, J Immunother Cancer) - "Overall, the data demonstrate that RP1 remodels the tumor microenvironment through a combination of direct and indirect effects on both tumor and immune cells, resulting in an overall more inflamed phenotype."

IO biomarker • Journal • Hematological Malignancies • Herpes Simplex • Leukemia • Oncology • CSF2 • IFNAR1 • ITGAM • STING

RPL-123-01: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (clinicaltrialsregister.eu) - P4 | N=41 | Not yet recruiting | Sponsor: Replimune Group Inc.

New P4 trial • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

ARTACUS: Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Replimune Inc. | N=65 ➔ 90 | Trial completion date: Jan 2028 ➔ Nov 2029 | Trial primary completion date: Sep 2027 ➔ Jul 2029

Enrollment change • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Bone Marrow Transplantation • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (clinicaltrials.gov) - P2 | N=340 | Active, not recruiting | Sponsor: Replimune Inc. | Trial primary completion date: Dec 2025 ➔ Jun 2028

Monotherapy • Trial primary completion date • Cutaneous Melanoma • Genetic Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF • MSI

Primary analysis of the registration-intended cohort of patients with anti–PD-1–failed melanoma from the IGNYTE trial of RP1 plus nivolumab, including clinical subgroup and initial biomarker data (SITC 2024) - P2 | "Ethics Approval The study was conducted in accordance with the ethical principles originating from the Declaration of Helsinki and was approved by the institutional review board/ethics committee at each participating site. Written informed consent was obtained from all patients prior to the conduct of any study-related procedures."

Biomarker • Clinical • IO biomarker • Late-breaking abstract • Melanoma • Oncology • Solid Tumor • CD8 • CSF2 • PD-L1

Efficacy and safety of RP1 combined with nivolumab in patients with anti–PD-1–failed melanoma from the IGNYTE clinical trial. (ASCO 2024) - P2 | "In pts who failed prior ipilimumab + nivo, the ORR was 26.4% (Table). The updated data from this expanded cohort show that RP1 + nivo provides durable and clinically meaningful antitumor activity in pts with anti–PD-1–failed melanoma. Responses were observed in both injected and uninjected lesions, including visceral lesions. The combination continues to be well tolerated."

Clinical • Cardiovascular • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • CSF2

Initial efficacy and safety of RP1 + nivolumab in patients with anti–PD-1–failed melanoma from the ongoing phase 1/2 IGNYTE study. (ASCO 2023) - P2 | "The initial data from this expanded cohort show that RP1 + nivo provides durable and clinically meaningful antitumor activity in pts with anti–PD-1–failed melanoma. Responses were observed in both injected and uninjected lesions, including visceral lesions. The combination continues to be well tolerated, with mostly on-target TRAEs."

Clinical • P1/2 data • Cutaneous Melanoma • Fatigue • Melanoma • Oncology • Solid Tumor • CSF2 • PD-L1

The Company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026. (The Manila Times)

PDUFA • Melanoma

Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Varun Monga, MBBS | Not yet recruiting ➔ Recruiting

Enrollment open • Angiosarcoma • Oncology • Sarcoma • Solid Tumor

Safety and efficacy results from an open-label phase 1b/2 study of RP1 oncolytic immunotherapy in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS) (SITC 2024) - P1/2 | "The study protocol was approved by the institutional review board or ethics committee of each participating site. All participants provided written informed consent before study-related procedures were conducted."

Clinical • IO biomarker • Metastases • Oncolytic virus • P1/2 data • Hematological Malignancies • Leukemia • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • CSF2

RPx: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Replimune Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

Efficacy of RP1 plus nivolumab in patients with advanced melanoma and primary resistance to prior anti–PD-1 therapy: A subgroup analysis from the IGNYTE trial (SMR 2025) - No abstract available

Clinical • Metastases • Melanoma • Oncology • Solid Tumor

Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma (clinicaltrials.gov) - P2 | N=18 | Not yet recruiting | Sponsor: Varun Monga, MBBS | Trial completion date: Jul 2029 ➔ Oct 2029 | Initiation date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Jul 2029 ➔ Oct 2029

Trial completion date • Trial initiation date • Trial primary completion date • Angiosarcoma • Oncology • Sarcoma • Solid Tumor

RP1 monotherapy in solid organ transplant recipients with locally advanced cutaneous squamous cell carcinoma (ARTACUS) (SMR 2025) - No abstract available

Clinical • Metastases • Monotherapy • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Unravelling the immune interactions of the oncolytic herpes simplex virus (oHSV) RP1® (ESMO-IO 2025) - "Ongoing proteomics experiments will assess the effect of RP1® on the antigen presentation pathways in DCs.Conclusions This study elucidates the interplay between RP1® and the immune system, demonstrating that DCs can cross-present antigens from RP1® infected tumor cells. We show that RP1® infection of tumors enhances CTL priming against TAAs, which is improved by the expression of the FMG GALV-GP-R- by RP1®."

IO biomarker • Head and Neck Cancer • Hematological Malignancies • Leukemia • Melanoma • Oncology • Solid Tumor • CD4 • CD69 • CD8 • IFNB1 • IFNG • IL2RA • ISG20 • MAGEA4 • PD-1 • TNFA

Efficacy and safety of RP1 oncolytic immunotherapy (vusolimogene oderparepvec) in advanced melanoma: Real-world data from a single center (ESMO-IO 2025) - "Background RP1, an intratumoral oncolytic immunotherapy, in combination with nivolumab has shown promising efficacy in anti-PD1-failed, advanced melanoma, a population with limited safe and effective options. Median overall survival was not reached. Any-grade adverse events (AE) were observed in 81.8% pts (most common AE was chills); no grade ≥ 3 occurred.Conclusions RP1 +/- anti-PD-1 demonstrates meaningful clinical benefit and a manageable safety profile in pts with advanced melanoma and limited therapeutic options."

Clinical • Metastases • Oncolytic virus • Real-world • Real-world evidence • Melanoma • Oncology • Solid Tumor

AN OPEN LABEL MULTICENTER PHASE 2 STUDY WITH SAFETY LEAD IN OF INTRATUMORAL VUSOLIMOGENE ODERPAREPVEC IN COMBINATION WITH PEMBROLIZUMAB IN PATIENTS WITH ANGIOSARCOMA (CTOS 2025) - P2 | "Standard treatments including paclitaxel or anthracycline based chemotherapies are associated with significant toxicities and tyrosine kinase inhibitors when used as single agents have limited response rates...In Phase 1/2 IGNYTE study trial cohort with anti-PD(L)-1 failed non melanomatous skin cancer including angiosarcoma patients, treated with intratumoral VO and IV nivolumab demonstrated an overall response rate of 33.3%. Patients aged ≥18 years with biopsy-proven cutaneous angiosarcoma that is either locally advanced and unresectable or metastatic, who have received and progressed on a first-line taxane- or anthracycline-based regimen and have received at least one prior immunotherapy-based regimen within 6 months prior to screening, are eligible for enrollment... N/A"

Clinical • Combination therapy • IO biomarker • P2 data • Angiosarcoma • Non-melanoma Skin Cancer • Oncology • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor