Is Oncolytics Biotech's GOBLET Study Making Headway in the Fight Against Pancreatic and Colorectal Tumors?

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Research and clinical trials have brought good news in treating pancreatic cancers in recent years, with the five-year survival rate increasing to 11%. However, the fight against many other cancers has advanced to a much higher survival rate.

Metastatic pancreatic cancers, which spread from the primary site to other parts of the body through the bloodstream, are being investigated by several companies that are conducting clinical trials of new treatments to improve survival rates.

In addition to studies being performed by large global companies such as Celgene Corp CELG, several biotech companies such as Paris-based Nanobiotix · NBTX and San Diego-based Oncolytics Biotech Inc. ONCY are reporting great strides in clinical trials.

What is GOBLET?

Oncolytics’ phase 1/2 trial, known as GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. It’s currently being conducted at 14 centers in Germany.  

AIO, a leading academic cooperative medical oncology group based in Germany, is managing the trial and Oncolytics is looking at the use of pelareorep in combination with Roche Holdings’ RHHBY anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.

Oncolytics is developing pelareorep, an intravenously delivered immunotherapeutic agent that induces anti-cancer immune responses and promotes an inflamed tumor phenotype. Pelareorep turns “cold” tumors “hot” through innate and adaptive immune responses to treat a variety of cancers.

Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer diagnosed in the U.S. alone in 2021. The American Cancer Society also estimated 60,430 new cases of pancreatic cancer and 9,090 new cases of anal cancers in the U.S. in 2021. 

Last May, Oncolytics announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer.  Despite the absence of chemotherapy in the treatment regimen, the study achieved a 42% disease control rate in difficult-to-treat second-line pancreatic cancer patients. A separate clinical study showed a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression.

GOBLET also investigates pelareorep therapy in metastatic colorectal cancer and is supported by preliminary early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients. GOBLET intends to build on these initial colorectal and pancreatic studies by evaluating biomarker data, which may be used to better select patients most likely to respond to treatment in future studies.

Oncolytics recently provided an update on the progress of the GOBLET study, reporting the safety run-ins have successfully been enrolled, and the study will be moving to full enrollment pending an independent safety review.

“We are very pleased with the trial’s progress to date. There is a pressing unmet need for agents that can synergize with immune checkpoint inhibitors (ICI) in gastrointestinal (GI) cancers, as fewer than half of these patients respond to ICI monotherapy,” Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial said. “These low response rates are driven by immunosuppressive tumor microenvironments, which pelareorep has been shown to reverse in prior clinical studies in GI, breast and hematological cancers.” 

Oncolytics is also currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in other solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For more information, visit www.oncolyticsbiotech.com.

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