BioLineRx to Present Phase 2 Study Data on Motixafortide for Pancreatic Cancer at ASCO 2024
Chicago, Illinois, June 1, 2024 — BioLineRx has unveiled encouraging data from its CheMo4METPANC Phase 2 clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study, which is investigating an innovative combination therapy for first-line treatment of pancreatic cancer (PDAC), has shown promising results in its pilot phase.
The CheMo4METPANC trial is exploring the efficacy of combining the CXCR4 inhibitor motixafortide and the PD-1 inhibitor cemiplimab with standard chemotherapies, gemcitabine and nab-paclitaxel. Initial findings indicate that this combination could significantly enhance treatment outcomes compared to traditional chemotherapy alone.
Key Findings from Pilot Phase
In a detailed analysis of biopsy samples from the 11 patients treated with the combination therapy, an increase in CD8+ T-cell density within tumors was observed for all patients. This immune response is considered a positive indicator of the therapy's effectiveness. The statistical significance of these findings was noted (P = 0.007).
As of February 2024, out of the 11 patients:
- 7 experienced a partial response, with 6 of these responses confirmed.
- 10 patients achieved disease control.
These results are particularly impressive when compared to historical data for gemcitabine and nab-paclitaxel alone, which typically show partial response and disease control rates of 23% and 48%, respectively. The preliminary median progression-free survival (PFS) for the combination therapy was reported at 9.6 months, surpassing the historical median PFS of 5.5 months for the standard regimen.
Expanding the Trial
Given these promising preliminary outcomes, the study has been expanded to a randomized trial with a planned increase in patient enrollment from 30 to 108. This larger trial aims to further validate the efficacy and safety of the combination therapy.
Philip Serlin, CEO of BioLineRx, expressed optimism about the results, highlighting the potential of motixafortide to modify the tumor microenvironment and activate immune responses. He emphasized the importance of continued collaboration with Columbia University in advancing this research.
Trial and Presentation Details
The CheMo4METPANC Phase 2 trial is sponsored by Columbia University and supported by BioLineRx and Regeneron. It stands as the first large-scale, multi-center, randomized study of its kind. The primary endpoint is progression-free survival, with secondary endpoints including safety, response rate, disease control rate, duration of clinical benefit, and overall survival.
The trial’s findings were presented at ASCO 2024 by Dr. Gulam Abbas Manji from Columbia University Herbert Irving Comprehensive Cancer Center. The presentation was part of the Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary track.
The Urgency for New Treatments
Pancreatic cancer remains one of the most challenging cancers to treat, with a low rate of early diagnosis and poor prognosis. In 2024, an estimated 66,000 adults in the U.S. will be diagnosed with pancreatic cancer, contributing significantly to cancer mortality rates. The development of new treatments, such as the combination therapy being evaluated in the CheMo4METPANC trial, is critical for improving outcomes for these patients.
About Motixafortide
Motixafortide targets and inhibits the CXCR4 receptor, which is overexpressed in several cancers, including PDAC. By blocking this receptor, motixafortide enhances the immune system’s ability to attack the tumor. This approach aims to shift the immune landscape towards a more pro-inflammatory and anti-tumoral state.
Conclusion
BioLineRx’s presentation at ASCO 2024 highlights the potential of combination therapies to improve treatment outcomes for pancreatic cancer. The expanded Phase 2 trial will be crucial in determining whether this promising strategy can become a viable new treatment option for patients facing this difficult-to-treat disease.
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