IO360: Motixafortide shows Phase II efficacy in first-line pancreatic cancer

Pancreatic ductal adenocarcinoma (PDAC), notorious for its resistance to traditional immunotherapies, presents a formidable challenge in clinical management. Despite advancements in cancer treatment, PDAC patients continue to face a dismal prognosis due to the limited efficacy of existing immunotherapeutic approaches. This refractory nature of PDAC underscores the pressing necessity for innovative treatments. However, there is now promise from the pilot phase of the CheMo4METPANC trial suggesting that combining first-in-class CXCR4 inhibitor Aphexda (motixafortide), immune checkpoint inhibitor Libtayo (cemiplimab), and standard-of-care chemotherapies, gemcitabine and Abraxane (nab-paclitaxel), as first-line therapy yielded positive responses in patients diagnosed with metastatic PDAC.

At the 10th Annual Immuno-Oncology 360° (IO360) conference, held 27–29 February, results from the Phase II CheMo4METPANC clinical trial investigating the efficacy of motixafortide in treating first-line PDAC were displayed. At the data cutoff (July 2023), 7 out of 11 patients (64%) achieved a partial response (PR), with 5 of them (45%) confirmed as PRs. One patient witnessed resolution of the hepatic metastatic lesion, while three patients (27%) maintained stable disease, culminating in an impressive disease control rate of 91%. Recruitment for this study is presently underway, with an anticipated completion date of August 2025.

The CheMo4METPANC Phase II trial represents a notable advancement in BioLineRx‘s commitment to meeting the demands of PDAC patients, utilising novel therapeutic combinations to enhance treatment effectiveness and increase patient survival rates. Leading the first-line treatment paradigm as competitors for motixafortide are FOLFIRINOX and Bristol Myers Squibb’s Abraxane (taxol) with gemcitabine therapy; however, these therapies provide only modest survival benefits and a bleak outlook for patients. From a market standpoint, the debut of motixafortide may cause a significant shift in current treatment approaches for PDAC and have a competitive edge considering the high unmet need. Regarding motixafortide’s potential in terms of the addressable market, GlobalData’s epidemiology database reports 265,000 incident cases of PDAC in 16 major markets (US, France, Germany, Italy, Spain, UK, Japan, Australia, Brazil, Canada, Urban China, India, Mexico, Russia, South Africa, and South Korea) in 2023.