Oncolytics Biotech's Progress on the GOBLET Study and Expansion in the U.S. Market

Oncolytics Biotech Provides GOBLET Study Update

Oncolytics Biotech® Inc. (Nasdaq: ONCY), a clinical-stage immunotherapy firm, has made significant strides in the ongoing GOBLET trial, aimed at evaluating the efficacy of pelareorep in treating gastrointestinal cancers. This promising therapy is primarily assessed in patients suffering from malignancies that have proven challenging to treat, such as metastatic pancreatic cancers. This report outlines the updates on patient enrollment, the extension of U.S. clinical sites, and initial findings from different patient cohorts.

GOBLET Trial Overview

The GOBLET trial is structured to meticulously assess the efficacy of pelareorep, used in combination with existing therapies, to provide better outcomes for patients afflicted with severe gastrointestinal cancers. Supported partly by a grant from the Pancreatic Cancer Action Network (PanCAN), this study is designed to deliver comprehensive insights into treatment responses.

Dr. Dirk Arnold, the Director at Asklepios Tumorzentrum Hamburg and the principal investigator of the GOBLET study, stated, "The trial is imperative to understanding pelareorep's potential. Early data signal strong efficacy, enhancing our confidence that this drug can become a mainstay treatment for challenging tumors."

Cohort Results

Cohort 4: SCAC

One of the focal points of the GOBLET study is Cohort 4, which investigates pelareorep in patients with relapsed, unresectable Squamous Cell Carcinoma of the Anal Canal (SCAC). This cohort has shown significant potential; in January, initial results indicated a 33% overall response rate (ORR) from 12 evaluated patients. This rate is nearly triples the effectiveness previously observed with retifanlimab in similar patient populations. Enrollment for this cohort is underway, with expectations to reach completion by the end of 2025, and further efficacy updates will be shared in the latter part of that year.

Cohort 5: mPDAC

Cohort 5 assesses the effects of pelareorep in combination with modified FOLFIRINOX on first-line metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) patients. The trial has approximately 40% enrollment completion projected, with a goal to fully enroll by the close of 2026. An important interim efficacy update is anticipated in early 2026, providing insights into overall survival rates and treatment responsiveness.

Expansion to U.S. Sites

In a strategic move, Oncolytics has initiated protocol amendments to facilitate the expansion of the GOBLET study to U.S. clinical sites. Once approved, prominent academic institutions such as Northwestern University are set to participate in this vital research. Dr. Devalingam Mahalingham is poised to lead the efforts for Cohort 5 at Northwestern, emphasizing the critical need for innovative immunotherapy strategies for U.S. patients fighting pancreatic cancer.

Dr. Mahalingham remarked, "The combination of pelareorep with a checkpoint inhibitor and chemotherapy shows early signs of durability that can reshape treatment protocols, offering much-needed hope to patients."

Looking Ahead

Jared Kelly, CEO of Oncolytics, highlighted the importance of leveraging clinical data to navigate regulatory pathways effectively. He affirmed the Company’s commitment to establishing pelareorep as a cornerstone immunotherapy for gastrointestinal cancers, where patient choices presently remain limited.

Oncolytics continues its journey to innovate and refine immunotherapeutic options that could potentially alter the treatment landscape for patients battling severe gastrointestinal tumors.

For more details about Oncolytics Biotech and its initiatives, visit Oncolytics Biotech's Official Website. Follow them on their social media channels for the latest updates and insights.