Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Vusolimogene oderparepvec (RP1), Vusolimogene Oderparepvec (VO)
Vusolimogene Oderparepvec · 3 trials · 4 indications
Time from the date of randomization to death due to any cause
Safety and tolerability will be reported as the percentage of the first 6 participants (the safety-lead in participants) who received at least one dose of study treatment with any reported treatment-emergent adverse events (TEAEs), \>= Grade 3 TEAEs, serious adverse events (SAEs), and TEAEs requiring discontinuation of VO. Adverse events will be classified using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Objective response will be measured per RECIST v. 1.1 and is defined as complete response (CR) or partial response (PR) and confirmed by repeat imaging \>=4 weeks after assessment for participants who completed at least 4 of the planned 8 intratumoral injections.
The percentage of all participants who received at least one dose of study treatment with any treatment-emergent adverse events (TEAEs), ≥ Grade 3 TEAEs, serious adverse events (SAEs), and TEAEs requiring discontinuation of VO. Adverse events will be classified using NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Proportion of patients with sentinel lymph node lymph node positivity (disease present in lymph node per pathologic assessment).
| Arm | Type | Description |
|---|---|---|
| VO + nivolumab | EXPERIMENTAL | - |
| Physicians Choice | ACTIVE_COMPARATOR | Choosing from 1 of the following (to be consistent with approved label and/or applicable local clinical guidelines): * Nivolumab + relatlimab (as Opdualag) * Anti-PD-1 monotherapy (nivolumab or pembrolizumab) * Single-agent chemotherapy (dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel) |
| Treatment (Vusolimogene Oderparepvec (VO), Pembrolizumab) | EXPERIMENTAL | All participants receive a single dose of VO on Day -14. On Cycle 1 Day 1 (C1D1), participants receive second dose of VO, and subsequent doses occur every 3 weeks for 7 cycles in combination with 200 mg pembrolizumab every 3 weeks for 8 cycles starting C1D1. After 8 cycles of pembrolizumab, participants may have the pembrolizumab dose schedule altered to a single 400 mg dose every 6 weeks, and treatment with pembrolizumab may continue for up to 2 years after starting first dose on C1D1. Participants may receive up to eight additional doses of VO after progression for a total of 16 dosing days. Safety follow up visits occur 30 and 90 days after last dose of either treatment (whichever drug was taken last) or after the participant has taken 2 years of pembrolizumab as a part of this study. |
| Vusolimogene oderparepvec (RP1) | EXPERIMENTAL | Patients will receive 3 doses of RP1 (1.0 mL/injection; 10e6 PFU/mL for the first dose, and 10e7 mL for the subsequent 2 doses). The drug will be injected into the skin at the tumor biopsy site at baseline (day 1), day 15, and day 21, 4-5 weeks prior to SOC WLE and SLNB. Definitive surgery will occur up to 28-35 (± 2 days) days from first injection, to avoid treatment delay. |
| Name | Type | Description |
|---|---|---|
| Vusolimogene Oderparepvec | BIOLOGICAL | Genetically modified Herpes Simplex Type 1 Virus. |
| Nivolumab | BIOLOGICAL | Anti-PD-1 Monoclonal Antibody |
| Nivolumab + Relatlimab | BIOLOGICAL | Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody. |
| Pembrolizumab | BIOLOGICAL | A programmed death receptor-1 (PD-1)-blocking antibody indicated. |
| Single-agent chemotherapy | DRUG | Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel. |
| Vusolimogene Oderparepvec (VO) | BIOLOGICAL | Given intratumorally |
| Vusolimogene oderparepvec (RP1) | BIOLOGICAL | Vusolimogene Oderparepvec is a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. |
Key Inclusion Criteria: I 1. Male or female who is 12 years of age or older at the time of signed informed consent. I 2. Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma, as per AJCC staging system, 8th edit...
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Vusolimogene Oderparepvec (VO) is an investigational oncology therapy being studied for melanoma, advanced melanoma, and angiosarcoma. It is currently in clinical development, including a Phase 3 trial for advanced melanoma that progressed on anti-PD-1 and anti-CTLA-4 drugs.
Vusolimogene Oderparepvec is being developed by Replimune Group, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker REPL. The company is conducting clinical trials of this investigational therapy across multiple oncology indications.
Vusolimogene Oderparepvec is in Phase 3 clinical development for advanced melanoma, with an active Phase 3 trial (IGNYTE-3) currently recruiting. It is also being studied in earlier-phase trials for melanoma and angiosarcoma. The drug is investigational and not yet approved.
Vusolimogene Oderparepvec is being studied in three recruiting trials: NCT06216938 (early Phase 1 in primary melanoma), NCT06264180 (Phase 3 IGYTE-3 in advanced melanoma), and NCT06898970 (Phase 2 in angiosarcoma). These trials are enrolling patients in the United States and several European countries.
Yes, Vusolimogene Oderparepvec is also known as RP1 and is sometimes abbreviated as VO. These names refer to the same investigational drug being developed by Replimune Group for oncology indications.