Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pelareorep · 3 trials · 8 indications
Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1
Overall response rate at week 16 according to RECIST V1.1
Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1
DCR (complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) assessed by the investigators according to RECIST v 1.1.
OS is defined as the time from date of first treatment to death from any cause
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Cohort 1 | ACTIVE_COMPARATOR | Patients receive paclitaxel alone. |
| Cohort 2 | EXPERIMENTAL | Patients receive pelareorep + paclitaxel. |
| Cohort 3 | EXPERIMENTAL | Patients receive pelareorep + paclitaxel + avelumab. |
| Cohort 1: Metastatic Pancreatic Cancer 1L | EXPERIMENTAL | Patients with first-line (1L) locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC): Pelareorep and atezolizumab added to gemcitabine and nab-paclitaxel |
| Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR) | EXPERIMENTAL | Patients with 1L metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSIH) or mismatch repair deficient (dMMR) tumors: Pelareorep and atezolizumab |
| Cohort 3: Metastatic Colorectal Cancer 3L | EXPERIMENTAL | Patients with third-line (3L) mCRC independent of microsatellite instability (MSI)/dMMR status: Pelareorep and atezolizumab added to trifluridine/tipiracil |
| Cohort 4: Metastatic Unresectable Anal Cancer >/=2L | EXPERIMENTAL | Patients with \>/= 2L locally advanced/metastatic unresectable squamous cell carcinoma of the anal canal (SCCA) of viral or non-viral origin after prior systemic chemotherapy: Pelareorep and atezolizumab |
| Cohort 5: Metastatic PDAC 1L | EXPERIMENTAL | Patients with 1L metastatic PDAC: Pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | Bevacizumab (5 mg/kg) IV infusion |
| FOLFIRI | DRUG | irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion |
| Pelareorep | DRUG | pelareorep 4.5 x 10\^10 TCID50 IV infusion |
| Paclitaxel | DRUG | Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle. |
| Avelumab | DRUG | Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle. |
| Atezolizumab | DRUG | Atezolizumab 840 mg IV infusion |
| Gemcitabine and nab-paclitaxel | DRUG | Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2) |
| Trifluridine Tipiracil | DRUG | Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily |
| mFOLFIRINOX Treatment Regimen | DRUG | mFOLFIRINOX- IV oxaliplatin 85 mg/m2; IV leucovorin 400 mg/m2; IV irinotecan 150 mg/m2; 5-FU 2400 mg/m2 by 46-hour infusion, per local standard of care |
Inclusion Criteria: * Histologically confirmed cancer of the colon or rectum with documented metastasis * Measurable disease per RECIST v. 1.1 * Not candidates for curative surgery or curative radiation * Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in ...
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Pelareorep is an investigational oncolytic virus being studied for metastatic breast cancer, RAS-mutated metastatic colorectal cancer, and metastatic anal cancer. It is being evaluated in combination with other agents, including checkpoint inhibitors and chemotherapy, across multiple clinical trials.
Pelareorep is being developed by Oncolytics Biotech Inc., a biopharmaceutical company traded under the ticker symbol ONCY. The company is conducting clinical trials of Pelareorep in oncology indications.
Pelareorep is in Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. The trials are active but not recruiting or currently recruiting patients.
Pelareorep is being studied in three trials: NCT04215146 (BRACELET-1) in metastatic breast cancer, NCT07280377 in advanced gastrointestinal cancers including anal cancer, and NCT07446322 in RAS-mutated metastatic colorectal cancer. These trials combine Pelareorep with agents like avelumab, atezolizumab, and bevacizumab.
Pelareorep is an oncolytic reovirus designed to infect and replicate in cancer cells, inducing an inflammatory phenotype that may enhance anti-tumor immune responses. It is being studied in combination with immune checkpoint inhibitors to potentially improve treatment outcomes.
Pelareorep is also known as the oncolytic reovirus. It is a distinct investigational agent and is not the same as other approved oncolytic viruses. Its unique mechanism and combination strategies differentiate it in clinical development.