First-Line Motixafortide Plus Cemiplimab/Chemotherapy Induces Responses in mPDAC

First-line treatment with the combination of motixafortide (Aphexda), cemiplimab-rwlc (Libtayo), gemcitabine, and nab-paclitaxel (Abraxane) elicited responses in patients with metastatic pancreatic adenocarcinoma (mPDAC), according to initial data from the pilot portion of a phase 2 trial (NCT04543071).¹

Findings showed that evaluable patients (n = 11) achieved an overall response rate (ORR) of 55% (n = 6), and all responders experienced a partial response (PR). A confirmed PR was observed in 36% of patients (n = 4), and 1 patient experienced resolution of a hepatic metastatic lesion. Additionally, 27% of patients (n = 3) had stable disease, and the disease control rate (DCR) was 82%.

“These initial data from the pilot phase of this ongoing phase 2 study give us hope that motixafortide could potentially serve as the backbone of a new treatment regimen for PDAC, which is among the most difficult cancers to treat,” Philip Serlin, chief executive officer of BioLineRx, stated in a news release.“We are deeply committed to this important collaboration with Columbia University investigators and eagerly look forward to the data from the randomized phase of the trial.”

Based on early efficacy and safety data, the phase 2 study was amended to be a randomized trial.² The ongoing, open-label, multicenter study is enrolling patients at least 18 years of age with pathologically or cytologically confirmed mPDAC who have an ECOG performance status of 0 or 1.

Key exclusion criteria include prior systemic antineoplastic therapy, central nervous system metastases, most autoimmune conditions, and the presence of HIV, hepatitis B, or hepatitis C.

Under the amended protocol, patients are being randomly assigned 1:1 to receive 1.25 mg/kg of subcutaneous motixafortide for 5 days during priming, followed by twice-weekly dosing, plus 350 mg of intravenous (IV) cemiplimab once every 21 days, and 1000 mg/m2 of gemcitabine plus 125 mg/m2 of nab-paclitaxel on days 1, 8, and 15 of every 28-day cycle; or gemcitabine plus nab-paclitaxel alone.

Progression-free survival is serving as the trial’s primary end point. Secondary end points include ORR, DCR, duration of clinical benefit, and overall survival. Exploratory end points consist of predictive biomarkers for response, the effect of the combination on the immune microenvironment, and the potential impact of the combination on transcriptome.

Enrollment in the phase 2 portion of the study is ongoing.

References

1. BioLineRx announces encouraging data from pilot phase of phase 2 combination clinical trial with motixafortide in first-line pancreatic cancer (PDAC). News release. BioLineRX. September 28, 2023. Accessed October 2, 2023. https://ir.biolinerx.com/news-releases/news-release-details/biolinerx-announces-encouraging-data-pilot-phase-phase-2
2. Manji GA, May MS, Pellicciotta I, et al. CheMo4METPANC: A phase 2 study with combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in metastatic treatment-naïve pancreas adenocarcinoma. J Clin Oncol. 2023;41(suppl 16);TPS4200. doi:10.1200/JCO.2023.41.16_suppl.TPS4200