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

A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti–PD-1–failed melanoma from the IGNYTE clinical trial. (ASCO 2026) - P2 | "The 3-year landmark OS rate of 45.5% in the overall population and 81.8% among responders provides further evidence that the deep and durable responses provided by RP1 + nivo translate into long term clinical benefit, including extended OS in pts with melanoma post-confirmed progression on prior anti–PD-1–based therapy."

Clinical • Melanoma • Solid Tumor • CSF2 • PD-L1

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

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

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

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

Enrollment open • Angiosarcoma • Oncology • Sarcoma • Solid Tumor

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Melanoma: Cutaneous, Version 3.2026 (NCCN)

NCCN guideline • Cutaneous Melanoma

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

Replimune Reports Fiscal First Quarter 2027 Financial Results and Provides Corporate Update (The Manila Times) - "The Company has begun launch preparations in the U.S. and anticipates having product in the market within 60 days. Replimune also recently completed a $150 million financing to support commercial launch and the ongoing IGNYTE-3 confirmatory trial."

Financing • Launch US • Melanoma

Program Highlights & Milestones (The Manila Times) - "IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician's choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint, expected to readout in 2030, is overall survival, and key secondary endpoints are progression free survival and overall response rate....REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling....Phase 2/3 transition is expected in Q1 2027."

P3 data • Trial status • Melanoma • Uveal Melanoma

Biodistribution, shedding, and transmissibility of vusolimogene oderparepvec (RP1). (PubMed, Front Oncol) - "Patients received intratumoral RP1 in combination with nivolumab, with serial collection of blood, urine, injection-site, dressing, and oral mucosal samples during treatment and follow-up. No evidence of transmission of RP1 was observed. These findings support the favorable biosafety profile of RP1 with only a negligible risk of environmental release or secondary transmission during clinical use."

Journal • Genetic Disorders • Herpes Simplex • Infectious Disease • Melanoma • Oncology • Skin Cancer • Solid Tumor

FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma (FDA) - "The safety and efficacy of Tudriqev were evaluated in IGNYTE (NCT03767348)...The recommended dosage of vusolimogene oderparepvec-wtpg is 1 mL/cm of the largest dimension of the tumor, for a maximum of 10 mL across all lesions treated per dose. The size of each injectable lesion should be assessed on each treatment day to determine the required vusolimogene oderparepvec-wtpg volume."

Accelerated approval • FDA approval • Melanoma

Oncolytic Virotherapy, Long Stalled, Nears Second Approval. (PubMed, Cancer Discov) - "Nearly 11 years after T-VEC became the first oncolytic virus approved in a major market, the closest candidate to follow it-Replimune's RP1, now facing an FDA advisory committee-remains a locally injected herpesvirus for melanoma, underscoring how little the field has advanced. Researchers blame a stack of unresolved obstacles-flawed trial designs, mistimed drug combinations, tumor defenses, such as hypoxia, and the inability to deliver most viruses intravenously-even as smarter sequencing, neoadjuvant approaches, and a bladder-cancer virus near approval hint at renewed momentum."

Journal • Bladder Cancer • Genito-urinary Cancer • Melanoma • Oncology • Solid Tumor

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma (GlobeNewswire) - "The committee discussed two topics: (1) whether the single-arm IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response in the proposed population; and (2) the clinical meaningfulness of the response rate and duration of response reported in IGNYTE, and whether the observed responses are indicative of systemic antitumor activity attributable to RP1....Advisory Committee voted 10 to 3 that the efficacy results from the IGNYTE study are evaluable and clinically meaningful....The FDA's target action date under the Class 1 resubmission is August 2, 2026."

FDA event • Melanoma

US FDA staff raise efficacy concerns on Replimune's skin cancer drug ahead of meeting (Yahoo Finance) - "'The FDA ⁠review team concludes that this BLA (application) does not include an ​adequate and ​well-controlled ​investigation that demonstrates ‌substantial evidence of effectiveness.'....The FDA declined to approve the drug for the second time in two ‌years in April, ​citing reliance on ​a ​single-arm study without a ‌control group, and ​asked for ​more data from a well-controlled trial demonstrating adequate evidence ​of ‌the drug's effectiveness."

FDA event • Melanoma

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Replimune, Inc. | Trial completion date: Aug 2034 ➔ Mar 2031 | Trial primary completion date: Jan 2029 ➔ Sep 2030

Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

RPx: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Replimune Inc. | Phase classification: P ➔ P4

Phase classification • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

The Evolving Role of Intralesional Therapy in In-Transit Melanoma. (PubMed, Curr Oncol) - "Platforms such as talimogene laherparepvec (T-VEC), vusolimogene oderparepvec (RP1), and tavokinogene telseplasmid with electroporation (Tavo-EP) demonstrate enhanced activity in combination with checkpoint blockade, whereas therapies limited to pattern-recognition receptor activation have shown inconsistent efficacy in randomized trials. Emerging noninvasive technologies, such as focused ultrasound, may further expand strategies for remodeling the immunosuppressive tumor microenvironment to enable immune sensitization. These findings support a shift toward mechanism-based treatment selection in which locoregional therapies function to overcome immune resistance rather than solely reduce tumor burden."

Journal • Review • Melanoma • Oncology • Solid Tumor

Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma (GlobeNewswire) - "The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July....The resubmission seeks accelerated approval of RP1 in advanced melanoma based on data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen."

FDA event • FDA filing • PDUFA • Melanoma

Safety and feasibility of intratumoral injection of RP1 or RP2 oncolytic immunotherapies in visceral metastases. (ASCO 2026) - P1, P2 | "Pts received RP1/RP2 for up to 8 doses as monotherapy or in combination with nivolumab IV starting at cycle 2 or 4 for up to 2 years. RP1/2 injections into visceral mets were well tolerated, with a comparable safety profile to liver and lung biopsies performed in other clinical settings. The observed RPx safety profile supports the incorporation of IT injections into deep visceral tumors as part of cancer therapy. All-grade treatment-related adverse events (>15%)."

Clinical • Oncolytic virus • Oncology • Respiratory Diseases • Solid Tumor • CSF2

A randomized, controlled, multicenter, phase 3 study of RP1 (vusolimogene oderparepvec) combined with nivolumab vs physician's choice of therapy in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3). (ASCO 2026) - P2, P3 | "Among available treatments, combination anti–PD-1 (nivolumab) + anti–CTLA-4 (ipilimumab) therapy is associated with the highest ORR and best PFS and OS. Patients (N ≈ 400) will receive RP1 + nivolumab or physician's choice (nivolumab + relatlimab, anti–PD-1 monotherapy rechallenge [nivolumab or pembrolizumab], or single-agent chemotherapy [dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel]). The primary endpoint of the study is OS; the key secondary endpoints are PFS and ORR per RECIST 1.1."

Clinical • IO biomarker • Metastases • P3 data • Cutaneous Melanoma • Herpes Simplex • Melanoma • Solid Tumor • BRAF

Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA (GlobeNewswire) - "The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritize its review in recognition of the significant unmet need for patients in the advanced melanoma community....The BLA is supported by data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen."

FDA filing • Melanoma

Replimune Presents 3-Year Landmark Overall Survival Analysis from IGNYTE Clinical Trial During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "RP1 (vusolimogene oderparepvec) plus nivolumab achieved a median overall survival (mOS) of 32.9 months in patients with anti–PD-1–failed advanced melanoma, a population with limited treatment options; At 3 years, 47.8% of all treated patients remained alive, rising to 83.5% among responders, underscoring the depth and durability of the treatment's benefit; The objective response rate (ORR) was 33.6%, with a median duration of response (DOR) of 24.8 months; 44.8% of responders maintained their response at 3 years; Meaningful survival benefit was observed across all key patient subgroups, including those with varying disease stage, PD-L1 expression status, prior anti–CTLA-4 therapy, and primary or secondary anti–PD-1 resistance; The combination continued to demonstrate a favorable and manageable safety profile over long-term follow-up, with predominantly Grade 1–2 constitutional side effects, no Grade 5 events, and no new safety signals identified."

P2 data • Melanoma

Intratumoral vusolimogene oderparepvec (RP-1) combined with PD-1 blockade in refractory advanced cutaneous squamous cell carcinoma: Two real-life cases (EADO 2026) - "Clinical, radiological, and histopathological responses were assessed, along with treatment feasibility and safety.Results A 53-year-old HIV-positive woman presented with an unresectable, PD-L1–negative right periocular cutaneous squamous cell carcinoma that progressed on pembrolizumab and cetuximab monotherapy, as well as on combined nivolumab plus ipilimumab. In this context, RP-1 has the potential to convert immunologically "cold" tumors into "hot" lesions and restore sensitivity to PD-1 blockade, independently of baseline PD-L1 expression. The two real-world cases presented here support the clinical feasibility and potential activity of combining intratumoral RP-1 with PD-1 inhibition in heavily pretreated la-cSCC, including tumors in challenging anatomical locations and in immunocompromised patients."

Clinical • IO biomarker • Metastases • Human Immunodeficiency Virus • Infectious Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Biomarker and updated clinical data for RP1 plus nivolumab in anti–PD-1–failed melanoma from the IGNYTE trial demonstrate reversal of mechanisms of resistance to immune checkpoint blockade (EADO 2026) - P2 | "These pharmacodynamic changes occurred predominantly in responders, including patients with no response to prolonged use of prior ipilimumab/nivolumab. No correlation was seen between TMB and clinical response.Conclusions Biomarker data demonstrated increased expression of a range of genes known to be associated with responsiveness to anti–PD-1 therapy, which is consistent with and provides a mechanistic basis for the observed clinical responses to RP1 plus nivolumab after prior anti–PD-1 failure. Disclaimer: The data in this abstract were previously presented on November 7, 2025, at the Society for Immunotherapy of Cancer (SITC) annual meeting (abstract 1327)."

Biomarker • Checkpoint block • Checkpoint inhibition • Clinical data • IO biomarker • Tumor mutational burden • Herpes Simplex • Melanoma • Solid Tumor • CD68 • CD8 • CSF2 • GZMA • IFNG • PD-L1 • PRF1 • TMB • TRB