In January 2016, BioLineRx entered into a collaboration with MSD, known as Merck in the U.S. and Canada, in the field of cancer immunotherapy. Based on this collaboration, in September 2016 BioLineRx initiated a Phase 2a study, known as the COMBAT study, focusing on evaluation of the safety and efficacy of BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, in patients with metastatic pancreatic adenocarcinoma. Partial results were presented at the 2018 ASCO Gastrointestinal Cancers Symposium (ASCO GI) and ASCO-SITC in January 2018, with top-line results expected in the second half of 2018.
In August 2016, in the framework of an agreement with MD Anderson Cancer Center, BioLineRx entered into an additional collaboration for the investigation of BL-8040 in combination with KEYTRUDA® in pancreatic cancer. BioLineRx is supplying BL-8040 for this Phase 2b study, which commenced in January 2017. This study was presented at the 2018 ASCO GI in January 2018.
In September 2016, BioLineRx entered into a collaboration with Genentech, Inc., a member of the Roche Group, in the framework of which both companies would carry out Phase 1b/2 studies investigating BL-8040 in combination with atezolizumab (TECENTRIQ®), Genentech's anti-PDL1 cancer immunotherapy, in various solid tumors and hematologic malignancies. Genentech commenced a Phase 1b/2 study for the treatment of pancreatic cancer in July 2017, as well as a Phase 1b/2 study in gastric cancer in October 2017. Genentech expects to commence an additional Phase 1b/2 study in lung cancer by early 2018. In September 2017, BioLineRx initiated a Phase 1b/2 study under this collaboration in acute myeloid leukemia (AML). These studies will evaluate the clinical response, safety and tolerability of the combination of these therapies, as well as multiple pharmacodynamic parameters.
Investigator Initiated Studies
BioLineRx is currently conducting several investigator-initiated studies in a variety of indications to support the interest of the scientific and medical communities in exploring additional uses for BL-8040. These studies serve to further support current indications and broaden BL-8040 mechanism of action.