AstraZeneca’s PD-L1 inhibitor Imfinzi and Bavarian Nordic’s cancer vaccine CV301 will be combined in a phase I/II trial involving patients with metastatic colorectal or pancreatic cancers.
The two companies are providing their drugs as well as funding for the independent trial, which will be run by Georgetown University in the US and led by Michael Pishvaian of the university’s Lombardi Comprehensive Cancer Center.
Copenhagen, Denmark-based Bavarian Nordic said the study will look at CV301 and Imfinzi (durvalumab) in combination with maintenance chemotherapy and will start with a lead-in phase to test the safety of the regimen. A second phase will consist of two parallel trials with around 26 patients apiece in the two cancer indications.
“Colorectal and pancreatic cancers are among the most difficult-to-treat malignancies to date,” commented Pishvaian. “While therapeutic options for these patients remain limited, combining a targeted cancer vaccine with a checkpoint inhibitor could result in a novel approach to fighting these diseases, as well as improved patient outcomes.”
Imfinzi is the third checkpoint inhibitor to be tested alongside CV301, a poxvirus-based vaccine which targets two antigens (CEA and MUC1) over-expressed in multiple solid tumours including lung, bladder, colorectal and pancreatic cancers. The vaccine has also been paired with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) in a non-small cell lung cancer (NSCLC) study as well as Roche’s PD-L1-targeting drug Tecentriq (atezolizumab) in bladder cancer.
CV301 is Bavarian Nordic’s lead cancer vaccine after its much-delayed Prostvac candidate for prostate cancer failed to meet the mark in a phase III trial last year, wreaking havoc with the company’s share price.
The setback was also a big disappointment for Bristol-Myers Squibb (BMS), which took an option on Prostvac in a $975m deal signed in 2015, although Prostvac is still in some phase II combination studies that are due to generate results in the coming months and years.