BioLineRx Ltd BLRX announced data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination trial of motixafortide and gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).
The pilot phase of the Phase 2 study enrolled 11 patients with metastatic pancreatic cancer.
As of May 2023, 6 patients (55%) experienced a partial response (PR), of which 4 (36%) were confirmed PRs, with one patient experiencing resolution of the hepatic (liver) metastatic lesion.
Three patients (27%) experienced stable disease, resulting in a disease control rate of 82%.
These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care, the chemotherapy combination gemcitabine and nab-paclitaxel.
Based on these pilot data, earlier this year, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients.
Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and is expected to be the second leading cause of cancer-related death in the U.S. by 2023.
Earlier this month, the FDA approved BioLineRx's Aphexda (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
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