Pancreas image | Image credit: © Лилия Захарчук – Stock.adobe.com
Motixafortide, a CXC4 inhibitor, when combined with the PD-1 inhibitor cemiplimab and the standard of care (SoC) chemotherapy treatment gemcitabine and nab-paclitaxel (MCGN) Phase 2 Data from the CheMo4METPANC trial (NCT04543071) showed some positive results against (mPDAC).
This data, presented as an abstract as part of the American Association for Cancer Research (AACR) special meeting on pancreatic cancer, shows that the combination of MCGNs may be more effective than SoC alone. This trial is the first large, multicenter, randomized study to evaluate this treatment combination.
“These early data from the ongoing pilot Phase 2 study demonstrate that motixafortide is a promising candidate for PDAC, one of the most difficult-to-treat cancers,” said Philip Sahlin, CEO. “This gives us hope that it may serve as the backbone for new treatment plans for patients.” he said in a BioLineRx Ltd press release.1
As of May 2023, 6 of 11 participants (55%) experienced a partial response (PR). Of these 6 patients, 4 patients (36% had a confirmed PR and 1 patient experienced resolution of liver metastatic disease; 3 patients (27%) experienced stable disease and disease control. The historical PR and DCR rates for gemcitabine and nab-paclitaxel (GN) were 23% and 48%, respectively.
This open-label, multicenter, investigator-initiated, single-arm pilot study was conducted at Columbia University and Brown University and began on November 9, 2020. The study was scheduled to enroll 10 patients, but ultimately enrolled 11 patients with mPDAC. The median age was 58. Two patients were female and three were black. The primary objective was to evaluate the efficacy of MCGN for her untreated mPDAC.2
Eligibility criteria include confirmed mPDAC diagnosis, adequate hematology and end-organ function within 14 days before study initiation, and DVT testing. Exclusion criteria included previous systemic therapy, radiotherapy, or surgery for PDAC. Unresolved adverse events (AEs) from previous anticancer treatment. Active or history of autoimmune disease; uncontrolled pleural, pericardial, or ascites; and uncontrolled tumor-related pain.3
Five patients remain on the study with a median follow-up of 9.5 months, with treatment duration ranging from 2 to 11.6 months. Four patients discontinued treatment due to disease progression, one patient withdrew consent, one was removed at physician’s discretion, and five patients died. Nine patients enrolled in the trial experienced grade 3 to grade 4 treatment-related AEs. These AEs included urticaria (18%), allergic reactions, bone pain, hypertension, pain, and rash (all 9%).2
COMBAT/KEYNOTE-202 (NCT02826486) exam: PD-1 inhibitors pembrolizumab (Keytruda) and motixafortide When combined with chemotherapy, a 77% disease control rate was achieved in PDAC, suggesting that motixafortide can help enhance the efficacy of immunotherapy.Four
Based on the results of this trial, the study will move into a randomized phase 2 trial with 112 participants, with progression-free survival (PFS) as the primary endpoint.2 The study is currently recruiting participants and has an estimated study completion date of August 2025.3