PCI Biotech Holding ASA announced that the company has decided to stop the RELEASE study and focus their drug development efforts on the promising immunotherapy opportunities with both fimaVacc and fimaNAc assets. The decision to stop the RELEASE study is based on recent randomised Phase III clinical trial results presented at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI, January 20-22, 2022) from the TOPAZ-1 study, demonstrating that a combination of immune checkpoint inhibition with gemcitabine and cisplatin provides a significant survival benefit to patients with advanced biliary tract cancer compared with placebo plus gemcitabine and cisplatin. These results are expected to rapidly change the first line standard treatment for patients with unresectable perihilar or distal bile duct cancer,
which is the intended patient population of the RELEASE trial. Such a change in the standard of care treatment will render the RELEASE trial challenging to complete and potentially inadequate for approval and will significantly diminish the opportunity for PCI Biotech's treatment approach in this patient population. The impact on the RELEASE trial of the recent clinical trial results presented at ASCO GI has been discussed with key opinion leaders, confirming an expected rapid change and early adoption of immunotherapy plus chemotherapy as the new standard of care treatment for the RELEASE trial's target population.