Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RP1, Vusolimogene oderparepvec (RP1), Vusolimogene Oderparepvec (VO), VO
Vusolimogene oderparepvec · 6 trials · 15 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.
Percentage of subjects with adverse events (AEs)
Percentage of subjects with serious adverse events (SAEs)
Percentage of subjects with dose limiting toxicities (DLTs)
Percentage of overall response rate (ORR) for all participants
Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation
The effect of RP1 on objective response rate (ORR) as assessed by Independnet Central Review (ICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
The effect of RP1 on ORR as assessed by investigator review per modified RECIST 1.1 (mRECIST 1.1)
The safety and tolerability of single-agent RP1 in solid organ transplant patients with other skin cancers as assessed by incidence of patients with treatment-emergent adverse events (TEAEs) and by incidence of patients with biopsy-proven allograft rejection.
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. |
| Cemiplimab in combination with RP1 | EXPERIMENTAL | Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks |
| Cemiplimab | ACTIVE_COMPARATOR | Cemiplimab administered intravenously as a single therapy every 3 weeks |
| Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors | EXPERIMENTAL | anti-PD-1 monoclonal antibody |
| Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors | EXPERIMENTAL | Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors |
| Dose expansion of RP1 and nivolumab (IV) in superficial tumors | EXPERIMENTAL | Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors |
| Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors | EXPERIMENTAL | Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV) |
| RP1 (IT) and nivolumab (IV) in melanoma | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma |
| RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors |
| RP1 (IT) and nivolumab (IV) in NMSC | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer |
| RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with cutaneous melanoma who have been previously treated with anti-PD1 therapy |
| RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer who have been previously treated with anti-PD1/PD-L1 therapy |
| RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non small cell lung cancer who have been previously treated with anti-PD1/PD-L1 therapy |
| RP1, intra-tumoral injection, oncolytic virus | EXPERIMENTAL | RP1 administered as an intra-tumoral injection every 2 weeks. |
| 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 |
| Cemiplimab | DRUG | Cemiplimab administered intravenously |
| RP1 | BIOLOGICAL | RP1 administered intratumorally |
| RP1, intra-tumoral injection, oncolytic virus | BIOLOGICAL | Genetically modified herpes simplex type 1 virus |
| 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 is an investigational gene therapy being studied in several advanced cancers, including advanced melanoma, angiosarcoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, and non-small cell lung cancer. It is given as an intra-tumoral injection and is being tested both alone and in combination with checkpoint inhibitors such as pembrolizumab and nivolumab.
Vusolimogene oderparepvec is an oncolytic virus and gene therapy designed to be injected directly into tumors. It belongs to the -vec/-gene gene therapy class. Its development focuses on advanced melanoma and other solid tumors, and clinical trials pair it with anti-PD-1 agents such as nivolumab and pembrolizumab to combine direct tumor effects with immune checkpoint blockade.
Vusolimogene oderparepvec is being developed by Replimune Group, Inc., which trades on the Nasdaq under the ticker REPL. Replimune is running the clinical program for the asset across multiple solid tumor indications, including advanced melanoma, angiosarcoma, and skin malignancies in organ transplant recipients.
Vusolimogene oderparepvec is in Phase 3 development. The lead study, IGNYTE-3, is a randomized, active-controlled Phase 3 trial in advanced melanoma. The drug is investigational and has not been approved by the FDA. Additional earlier-stage trials are also ongoing, including Phase 2, Phase 1, and early Phase 1 studies.
Vusolimogene oderparepvec is being studied in several recruiting trials. NCT06264180 is the Phase 3 IGNYTE-3 study of VO plus nivolumab versus physician's choice in advanced melanoma. NCT06898970 is a Phase 2 trial in angiosarcoma combining VO with pembrolizumab. NCT06216938 is an early Phase 1 study in primary melanoma, and NCT04349436 is a Phase 1 study in transplant patients with advanced skin malignancies.
Yes. Vusolimogene oderparepvec is also known as RP1, and the abbreviation VO is used in trial titles as well. Searches for RP1, RP1 oncolytic virus, or intra-tumoral RP1 refer to the same Replimune asset. It is an oncolytic virus given by intra-tumoral injection and is distinct from other agents that share the RP1 shorthand.