BioLineRx has commenced the triple combination arm of the Phase IIa COMBAT/KEYNOTE-202 trial of BL-8040 and keytruda (pembrolizumab) for the treatment of metastatic pancreatic cancer (PDAC).
The arm is designed to evaluate the safety, tolerability and efficacy of BL-8040, keytruda and chemotherapy.
It is expected to enrol around 40 patients with unresectable metastatic pancreatic adenocarcinoma, who have progressed following first-line therapy before enrolment.
Patients will be treated with BL-8040 monotherapy priming treatment for five days, followed by the ongoing cycles of the chemotherapy, keytruda and BL-8040 combination until disease progression.
The trial’s primary goal is the objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria.
Its secondary goals comprise overall survival, progression free survival, and disease control rate.
BioLineRx CEO Philip Serlin said: “We believe that the addition of chemotherapy may be synergistic with BL-8040 and keytruda, as chemotherapy has been shown to reduce overall tumour burden while inducing immunogenic cell death, leading to activation and expansion of new tumour-reactive T-cells.
“Based on its mechanism of action, we believe that BL-8040 may facilitate the infiltration of these T-cells into the tumour core, alongside the restoration of T-cell activity within the tumour by keytruda.
“We look forward to results of the study expected in the second half of 2019.”
The initial COMBAT/KEYNOTE-202 study features an open-label, multicentre, single-arm trial design.
It aims to assess the safety and efficacy of BL-8040 in combination with keytruda in over 30 patients with metastatic pancreatic adenocarcinoma.
The trial was designed to investigate the clinical response, safety and tolerability of the study drug combination.
It was conducted in the US, Israel and additional territories as part of a collaboration agreement signed in 2016 between BioLineRx and MSD.