BioLineRx

APHEXDA® (Motixafortide); BL-8040 (Oncology Pipeline)

Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer.1 It is a highly aggressive cancer that is associated with poor patient outcomes because efficacious therapies do not yet exist.2 For all stages, the five-year survival rate is only 12 percent3 – the highest mortality rate in the U.S. among solid tumor malignancies. Globally, nearly a half million people were diagnosed in 2020 alone.4 Due to factors including an aging society,5 and increased rates of obesity and type 2 diabetes,6,7 PDAC incidence is growing. It is estimated that there will be 815,000 cases by 2040.8 Newer treatments like immunotherapy have limited efficacy, demonstrating a clear need to co-target alternative pathways. COMBAT Phase 2a Study | Proof-of-Mechanism, Initial Safety and Efficacy in a Cohort of Patients with Second-Line Disease Motixafortide is the most advanced CXCR4 antagonist in clinical development for metastatic PDAC and was successfully evaluated in the second part of the Phase 2 COMBAT study in combination with KEYTRUDA® (pembrolizumab) and chemotherapy (Onivyde plus 5-Fluorouracil/Leucovorin) as second-line treatment in patients with metastatic PDAC. In patients with very advanced disease, results from the COMBAT study demonstrated improvements across all endpoints compared to available historical control data, including overall survival, progression-free survival, and overall response rate. The triple combination was generally well tolerated, showing favorable safety and a low incidence of neutropenia and infections in treated patients.

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