Oncolytics scheduled an FDA Type C meeting to discuss a registrational pathway for pelareorep in squamous cell anal carcinoma, following ~30% ORR seen in the GOBLET study.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Oncolytics Biotech® Inc. announced that it has scheduled a Type C meeting with the U.S. Food and Drug Administration on April 16, 2026, to discuss a potential registrational development pathway for pelareorep in anal cancer.
The company plans to seek alignment on initiating a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor in patients receiving second-line and later therapy for squamous cell anal carcinoma (SCAC).
The proposed study would enroll approximately 60 to 70 patients who previously received both a checkpoint inhibitor and chemotherapy in the first-line setting.
These patients typically have no approved treatment options after disease progression. Oncolytics intends to use objective response rate (ORR) as the primary endpoint, with the goal of supporting a potential full approval.
Pelareorep, a systemically delivered investigational immunotherapy designed to activate innate immune-sensing pathways, has already shown encouraging activity in SCAC.
In Cohort 4 of the GOBLET study (NCT07280377), pelareorep combined with a checkpoint inhibitor achieved an ORR of approximately 30% in late-line patients, with a median duration of response of 17 months. These results compare with reported real-world outcomes showing response rates of roughly 10–14% and a median duration of response of about 9.5 months in similar patient populations.
Chief Executive Officer Jared Kelly said the upcoming FDA meeting is intended to align on statistical analysis and sample size for a potential pivotal single-arm study. He noted that the limited treatment options in late-line SCAC and the durability of observed responses support this development strategy. He also highlighted that the SCAC setting may provide a clearer efficacy signal and a potentially efficient regulatory pathway for pelareorep.
Squamous cell anal carcinoma is a rare malignancy with poor outcomes following progression on first-line therapy. According to global estimates, approximately 54,000 anal cancer cases occur annually, and the market for anal cancer therapies is projected to grow to about $2.3 billion between 2025 and 2035.
Reference
Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer, 06 April 2026, https://ir.oncolyticsbiotech.com/press_releases/oncolytics-biotech-announces-type-c-fda-meeting-to-discuss-single-arm-registrational-pathway-for-pelareorep-in-anal-cancer/
A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations with Pelareorep and Atezolizumab (GOBLET), ClinicalTrials.gov ID NCT07280377, https://clinicaltrials.gov/study/NCT07280377
About the Title
Samiksha Vikram Jadhav is a BPharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.