Preclinical data show pelareorep maintained tumour-reducing activity when combined with a pan-RAS inhibitor, with no evidence of antagonism between the two agents.

Pelareorep activity held with RAS inhibition during every-other-day dosing; its added effect was less evident after weekly dosing, with more studies planned.

Cohort 5 of the ongoing phase 1/2 GOBLET study evaluated the safety of pelareorep in combination with modified FOLFIRINOX with or without atezolizumab in patients with newly diagnosed metastatic pancr...

Key Points Oncolytics Biotech reported preclinical results evaluating pelareorep with a pan-RAS inhibitor in a RAS-driven colorectal cancer model. Durin

Can durability redefine MSS colorectal cancer? Discover how Oncolytics Biotech, Inc.’s pelareorep data could shift treatment strategy and market dynamics.

Oncolytics Biotech (Nasdaq: ONCY) reported clinical and translational data supporting pelareorep in second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer (mCRC).Key results: 33% objective response rate (ORR) in KRAS-mutant MSS patients versus historical 6–11% for bevacizumab+FOLFIRI, and reported >2x progression-free and overall survival versus bevacizumab+FOLFIRI. Translational analyses show increased KRAS-mutant–specific T cells. Company plans a sponsored controlled study to confirm findings.

Pelareorep plus a checkpoint inhibitor earned FDA fast track designation for pretreated, inoperable, recurrent, or metastatic squamous cell anal carcinoma.

Oncolytics is developing pelareorep, a unique immunotherapy with broad antitumor potential

Sep 08, 2025, 07:00 ET In KRAS mutant 2L mCRC, pelareorep delivers prolonged survival benefit with a median PFS and median OS approximately 2.5x the current ...

The landscape of cancer research is evolving, marked by significant breakthroughs and insights from prominent institutions and companies, paving the way for innovative therapies.

Oncolytics (Nasdaq: ONCY) announced FDA alignment on a pivotal, randomized controlled trial of pelareorep in unresectable metastatic squamous cell carcinoma of the anal canal (SCAC) on April 27, 2026. The trial is intended to support both accelerated and full approval within a single study framework.Key clinical signals cited include a combination study in second-line+ SCAC showing median duration of response 15.5 months vs 9.5 months and 12-month survival 82% vs 45.7% versus current standard of care. Final protocol will incorporate FDA feedback.

Reported Thursday, Sep 10 - 8:18am EDT (TheFly subscription required to read more.)

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Oncolytics - Pelareorep’s full history, mechanism, clinical evidence, FDA Fast Track designations, colorectal and anal cancer registration strategy, pancreatic and breast cancer optionality, financial position, dilution risk and future catalysts

Oncolytics Biotech (Nasdaq: ONCY) reported receiving written feedback from the U.S. FDA on the design of a potential pivotal Part B expansion of REO 033, its randomized study of pelareorep in second-line RAS-mutant, MSS metastatic colorectal cancer. According to the company, the FDA’s responses provide alignment around using objective response rate and duration of response to support a potential accelerated approval, with progression-free survival intended to support full approval. The ongoing Part A (n=60) is designed to generate clinical data to inform the decision to launch Part B. Oncolytics plans to begin Part B start-up activities once positive interim Part A data are available and will pursue an End-of-Phase meeting with the FDA to finalize key elements of the registration program. Pelareorep combination therapy in this setting has FDA Fast Track designation and prior studies (including REO 022) showed encouraging efficacy signals.

Reported Monday, Jul 20 - 9:02am EDT (TheFly subscription required to read more.)

Oncolytics Biotech (Nasdaq: ONCY) received U.S. FDA Fast Track designation for pelareorep in combination with a checkpoint inhibitor to treat patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal who have progressed on or were intolerant to one or more prior systemic therapies.The designation, which can enable more frequent FDA interactions, rolling BLA review and potential Priority Review, supports advancement toward a pivotal study. It is Oncolytics’ third Fast Track in gastrointestinal cancers, following KRAS‑mutated metastatic colorectal cancer and pancreatic cancer, in an estimated U.S. market approaching $1 billion annually with no FDA‑approved options after current first‑line standard of care.Fast Track was supported by GOBLET study data in advanced anal cancer showing an objective response rate of ~30%, longer median duration of response (15.5 vs. 9.5 months) and higher 12‑month overall survival (82% vs. 45.7%) versus historical benchmarks.