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Also known as RP1, intra-tumoral injection, oncolytic virus, RP1, intra-tumoral , oncolytic virus
RP1 · 1 trial · 4 indications
Percentage of subjects with adverse events (AEs)
Percentage of subjects with serious adverse events (SAEs)
Percentage of subjects with dose limiting toxicities (DLTs)
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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
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| RP1 | BIOLOGICAL | Genetically modified herpes simplex type 1 virus |
| nivolumab | BIOLOGICAL | anti-PD-1 monoclonal antibody |
Key Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * At least one measurable and injectable lesion * Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy * Have a predicted life expectancy of ≥...
RP1 is an investigational oncolytic virus being developed for the treatment of Non-Small Cell Lung Cancer (NSCLC) and Merkel Cell Carcinoma. It is administered via intra-tumoral injection and is currently in Phase 2 clinical development for these indications.
RP1 is an oncolytic virus designed to selectively replicate in and destroy tumor cells while also stimulating an anti-tumor immune response. It is administered directly into tumors via intra-tumoral injection, potentially enhancing its local and systemic anti-cancer effects.
RP1 is being developed by Replimune Group, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol REPL. The company is conducting clinical trials to evaluate RP1 as a monotherapy and in combination with other agents for various cancer indications.
RP1 is currently in Phase 2 clinical development. It has received FDA designations including Accelerated Approval, Breakthrough Therapy, and Priority Review, indicating its potential to address serious conditions. The drug remains investigational and has not yet been approved for commercial use.
RP1 is being studied in the IGNYTE trial (NCT03767348), a Phase 2 study evaluating RP1 as monotherapy and in combination with nivolumab in patients with Non-Small Cell Lung Cancer, Microsatellite Instability-High tumors, Non-melanoma Skin Cancer, and Cutaneous Melanoma. Another trial (NCT04349436) is investigating RP1 in organ transplant patients with advanced skin malignancies.
Yes, RP1 is the same as RP1 intra-tumoral injection. The drug is administered via intra-tumoral injection, and this route of administration is part of its name. RP1 is an oncolytic virus being developed by Replimune Group for the treatment of various cancers.