The safety and efficacy of the following investigational compound or investigational use of the marketed product have not been established. The use has not been approved by the U.S. Food and Drug Administration or other regulatory authorities.
Motixafortide is being evaluated in two Phase 2 trials in combination with checkpoint inhibitor and chemotherapy as a first-line therapy in metastatic pancreatic cancer.
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:
Combat/Keynote | Historical Data | |
---|---|---|
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 |
1 Macarulla Mercade et al, Pancreas 2020
2 Petrelli el al Eu J Cancer 2017
3 Onivyde prescribing information
4 Wang Gilliam Eu J Cancer 2019
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.
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