Pelareorep is an investigational intravenously delivered oncolytic reovirus immunotherapy developed for solid tumors and hematologic malignancies. It is a non-pathogenic isolate of reovirus serotype 3 Dearing with direct oncolytic and immune-activating effects. It remains in clinical development rather than approved commercial use.
The FDA granted Fast Track designation to Oncolytics Biotech's pelareorep combined with a checkpoint inhibitor for advanced squamous cell carcinoma of the anal canal. The designation follows encouraging GOBLET study data and supports development in an estimated $1 billion market with no approved therapies.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in KRAS-mutant colorectal cancer based on data showing 33% response rate and 27-month median survival. The company is launching a Phase 2 study and recently completed reincorporation from Canada to Nevada. This marks the second Fast Track Designation for pelareorep in gastrointestinal cancers.
The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.
The global oncology market is projected to nearly triple from $279.98 billion in 2026 to $748.17 billion by 2035, driven by rapid adoption of immunotherapy, checkpoint inhibitors, and cell therapies across solid tumors and hematologic cancers.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.
The global pancreatic cancer precision medicine market is projected to grow from US$ 610 million in 2024 to US$ 2,467.83 million by 2033 at a 16.8% CAGR, driven by advances in targeted therapies, genomic diagnostics, and liquid biopsies.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median survival of 27 months versus 11.2 months with standard treatment.
Oncolytics Biotech announced FDA Fast Track Designation for pelareorep combined with bevacizumab and FOLFIRI for second-line treatment of KRAS-mutant metastatic colorectal cancer, driving shares up 19.7%.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07446322 |
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT07280377 |
A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT05519059 |
Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer |
COMPLETED | PHASE1 |
| NCT05514990 |
Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT04445844 |
INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04215146 |
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04102618 |
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer |
TERMINATED | EARLY_PHASE1 |
| NCT03605719 |
Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma |
COMPLETED | PHASE1 |
| NCT02101944 |
Wild-Type Reovirus in Combination With Carfilzomib and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
COMPLETED | PHASE1 |
| NCT01199263 |
Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer |
COMPLETED | PHASE2 |
