SOLID TUMORS:Pancreatic Cancer
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor patient outcomes because efficacious therapies do not yet exist. For all stages, the five-year survival rate is only twelve percent – the highest mortality rate in the U.S. among solid tumor malignancies – and globally, nearly a half million people will be diagnosed each year. Newer treatments like immunotherapy have limited efficacy, demonstrating a clear need to co-target alternative pathways.
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. Highly encouraging results demonstrated improvements across all study endpoints, including overall survival, progression-free survival, and overall response rate in patients with very advanced disease.
The triple combination was generally well tolerated, showing favorable safety and a low incidence of neutropenia and infections in treated patients.
Efficacy data from the Phase 2a study is summarized below:
|Median Overall Survival (mOS)||6.5 months||4.7 months1|
|Median Progression Free Survival (mPFS)||4.0 months||2.7-3.1 months2,3|
|Confirmed Objective Response Rate (cORR)||13.2%||7.7%3|
|Disease Control Rate (DCR)||63.2%||29-52%2,4|
BioLineRx has initiated a collaboration to advance a randomized first-line metastatic PDAC clinical trial:
- In partnership with Columbia University, motixafortide is being studied in a randomized Phase 2 trial together with LIBTAYO® (cemiplimab) and chemotherapy as a first-line PDAC therapy.