Germany clears pelareorep pancreatic cancer trial continuation
Cancer-killing virus shows early promise, Oncolytics says
Authorities in Germany have given Oncolytics Biotech the go-ahead to continue enrollment in a Phase 1/2 clinical trial testing the company’s viral therapy pelareorep in people with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), a form of pancreatic cancer.
“Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed,” Thomas Heineman, MD, PhD, Oncolytics’ chief medical officer, said in a company press release.
Pelareorep is an oncolytic virus, one that’s been designed to infect and kill cancer cells. The virus aims not only to infect cancer cells, but also to trigger the body’s immune system to go on the attack and help fight the cancer.
“Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer,” Heineman said. Metastatic pancreatic cancer means that the cancer has spread outside of the pancreas to other parts of the body.
Oncolytics is running the GOBLET clinical trial testing pelareorep in people with PDAC and other types of digestive system cancers at centers in Germany. An earlier part of the trial enrolled people with PDAC and tested pelareorep in combination with atezolizumab — an immunotherapy sold under the name Tecentriq — and the chemotherapy medicines gemcitabine and nab-paclitaxel.
‘Encouraging’ response rates
The upcoming part of the trial, dubbed Cohort 5, will test pelareorep in combination with atezolizumab and a different chemotherapy regimen called modified FOLFIRINOX (mFOLFIRINOX), which uses four different anti-cancer drugs (leucovorin, fluorouracil, irinotecan, and oxaliplatin).
“Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep’s promise in this disease,” Heineman said. “GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy.”
This part of the study included a run-in group of three patients who were given pelareorep and mFOLFIRINOX, with or without atezolizumab. Authorities have now reviewed safety data from these patients and okayed further enrollment. The study is now expected to enroll an additional 30 patients. All will get pelareorep and mFOLFIRINOX, and half will also receive atezolizumab.
The main goals will be to evaluate safety and how well the cancers respond to the treatment. If positive results are seen, additional patients may be enrolled.
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