Motisafotide plus cimepilimab/
mPDAC chemotherapy | Image source:
© SciePro – stock.adobe.com
First-line treatment with a combination of motisaftide (Aphexda), cemiplimab-rwlc (Libtayo), gemcitabine, and albumin-bound paclitaxel (Abraxane) produced promising results in patients with metastatic pancreatic cancer (mPDAC), according to preliminary data from the 2019 trial portion. ease. Phase 2 trial (NCT04543071).1
The results showed that the overall response rate (ORR) of evaluable patients (n = 11) reached 55% (n = 6), and all responders achieved partial response (PR). Confirmed PR was observed in 36% of patients (n = 4), and 1 patient had response to liver metastases. Additionally, 27% of patients (n = 3) had stable disease, resulting in a disease control rate (DCR) of 82%.
Chief Executive Officer Philip Serlin said: “These preliminary data from the trial phase of this ongoing Phase 2 study give us hope that motixafortide has the potential to become the backbone of new treatment options for PDAC, one of the most difficult to treat cancers. “We are deeply committed to this important collaboration with Columbia researchers and eagerly await data from the randomized phase of the trial,” BioLineRx said in a press release.
Based on early efficacy and safety data, the Phase 2 study was modified into a randomized trial.2 This ongoing, open-label, multicenter study is enrolling patients aged at least 18 years with pathologically or cytologically confirmed mPDAC and an ECOG performance status of 0 or 1.
Major exclusion criteria included previous systemic antineoplastic therapy, central nervous system metastases, most autoimmune diseases, and the presence of HIV, hepatitis B, or hepatitis C.
Under the revised protocol, patients were randomly assigned in a 1:1 ratio to receive motisafotide 1.25 mg/kg subcutaneously for 5 days during initiation, followed by twice weekly dosing, plus 350 mg every 21 days. Intravenous (IV) cemiplimab and 1000 mg/m2 gemcitabine plus 125 mg/m2 nab-paclitaxel on days 1, 8, and 15 of each 28-day cycle; or gemcitabine plus nab-paclitaxel alone.
Progression-free survival was the primary endpoint of the trial. Secondary endpoints include ORR, DCR, duration of clinical benefit, and overall survival. Exploratory endpoints include predictive biomarkers of response, the impact of the combination on the immune microenvironment, and the potential impact of the combination on the transcriptome.
Recruitment for the second phase of the study is ongoing.
refer to
- BioLineRx announced encouraging data from the pilot phase of its Phase 2 combination clinical trial of motisaftide in first-line pancreatic cancer (PDAC). Press Releases. BioLineRX. September 28, 2023. Accessed 2 October 2023. https://ir.biolinerx.com/news-releases/news-release-details/biolinerx-announces-encouraging-data-pilot-phase-phase-2
- Manji GA, May MS, Pellicciotta I, et al. CheMo4METPANC: a combination chemotherapy (gemcitabine and nab-paclitaxel), a chemokine (CXC) motif receptor 4 inhibitor (motesaftide), and immune checkpoint blockade (cemiplimab) in previously untreated patients Phase 2 study in metastatic pancreatic cancer. Journal of Clinical Oncology. 2023;41(Suppl 16); TPS4200. doi:10.1200/JCO.2023.41.16_suppl.TPS4200