Oncolytics Biotech has received written feedback from the U.S. Food and Drug Administration (FDA) on a potential registrational pathway for pelareorep in second-line RAS-mutant, microsatellite-stable (MSS) metastatic colorectal cancer.
The feedback concerns the proposed pivotal Part B expansion of REO 033, an ongoing randomized trial evaluating pelareorep in combination with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone.
According to Oncolytics, the FDA feedback provides alignment around the potential use of objective response rate (ORR) and duration of response (DOR) to support an accelerated approval pathway, while progression-free survival (PFS) could support traditional full approval.
The FDA also recommended that the company hold an End-of-Phase meeting to reach agreement on key elements of the registrational program. Based on this recommendation, Oncolytics will not proceed with its previously planned Type D meeting.
Jared Kelly, Chief Executive Officer of Oncolytics Biotech, commented:
“Importantly, the feedback provides alignment around the potential use of response rate to support an accelerated approval pathway and progression-free survival to support full approval.”
About REO 033
REO 033 is evaluating pelareorep plus FOLFIRI and bevacizumab in patients with second-line RAS-mutant, MSS metastatic colorectal cancer.
The ongoing Part A is expected to enroll 60 patients. If interim results are supportive, the company plans to begin start-up activities for a pivotal Part B expansion that could potentially support a future regulatory submission.
The study builds on earlier clinical findings from REO 022, where pelareorep combined with FOLFIRI and bevacizumab showed antitumor activity in patients with KRAS-mutant MSS metastatic colorectal cancer.
About Pelareorep
Pelareorep is an investigational intravenously administered immunotherapy based on a double-stranded RNA virus. It is designed to selectively replicate in tumor cells while activating innate and adaptive antitumor immune responses. Oncolytics is developing the therapy across several gastrointestinal cancers, including colorectal, anal, and pancreatic cancer.
The next regulatory steps for the colorectal cancer program will depend on results from REO 033 Part A and further discussions with the FDA, including the planned End-of-Phase meeting.
Read further on OncoDaily: Oncolytics Biotech Launches Randomized Phase 2 REO-033 Trial for Pelareorep in RAS-Mutant MSS Metastatic Colorectal Cancer — With FDA Fast Track Behind It
