NEW YORK – Oncolytics Biotech on Tuesday said that it has partnered with Roche and German medical oncology group AIO to evaluate its immuno-oncolytic virus pelareorep and the anti-PD-L1 checkpoint inhibitor atezolizumab (Roche's Tecentriq) in various gastrointestinal cancers.
The Phase I/II trial, dubbed GOBLET, will be conducted at 25 centers in Germany under AIO's management and will enroll approximately 55 patients into four treatment protocols involving the pelareorep and atezolizumab combination. Metastatic pancreatic cancer patients will receive pelareorep-atezolizumab plus chemotherapy as a first-line option; previously treated metastatic colorectal cancer patients with microsatellite instability-high tumors will receive the combo as a second- and third-line treatment; previously treated metastatic colorectal cancer patients will get the combo plus TAS-102 (Taiho Oncology's Lonsurf) as a third-line treatment; and advanced or unresectable anal cancer patients will also get the duo.
The GOBLET trial will evaluate the combination's safety as a primary aim, but investigators will also assess overall response rates and blood-based biomarkers — specifically T-cell clonality and CEACAM6 expression — as secondary endpoints.
The multi-armed trial comes in the wake of early clinical evidence showing that Oncolytics' virus-based cancer therapy led to adaptive immune responses in KRAS-mutated colorectal cancer patients and prolonged progression-free survival in pancreatic cancer patients with low CEACAM6 expression.
Under the terms of its latest collaboration with Roche, the drug giant will provide atezolizumab to Oncolytics for use in the pelareorep clinical development program.
"Despite the great commercial success of checkpoint inhibitors, as many as four in five patients do not respond to these therapies in most GI malignancies, often due to an immunosuppressive tumor microenvironment," Dirk Arnold, director of the Asklepios Tumor Center in Hamburg and a principal investigator of the GOBLET study, said in a statement. "We believe that pelareorep treatment may substantially increase the proportion of patients who are eligible for, and respond to, checkpoint inhibitor therapy."