BioLineRx Ltd. announced the initiation of a randomized, investigator-initiated Phase 2 clinical trial in first line metastatic pancreatic cancer based on preliminary data from the single-arm pilot phase. The combination drug trial includes the investigational candidate motixafortide. Sponsored by Columbia University, the amended study will modify a single-arm trial whose original design called for expansion to an additional 30 patients if data from a pilot phase of 10 patients was encouraging (defined as 3 patients with partial response by RECIST criteria).

The amended randomized study will compare combination treatment with the Company's CXCR4 inhibitor (motixafortide), a PD-1 inhibitor (cemiplimab), and chemotherapy (gemcitabine, nab-paclitaxel) to chemotherapy alone in a larger number of patients (n= 102). Data from the pilot stage of the Phase 2 study is planned for submission to a congress later this year. The primary endpoint of the randomized trial is progression free survival (PFS).

Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.