Immutep has announced the conclusion of subject enrolment in the Phase II segment of the AIPAC-003 clinical trial of eftilagimod alpha (efti) to treat breast cancer.
This Phase II portion enrolled a total of 65 subjects with metastatic hormone receptor-positive (HR+), HER2-negative/low, or triple-negative breast cancer. Patients who have exhausted endocrine therapies, including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors were part of the trial.
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Participants were recruited from 22 clinical sites across Europe and the US.
These subjects were randomised into a 1:1 ratio to receive either 30mg or 90mg of efti combined with paclitaxel.
The trial will determine the optimal biological dose (OBD) of the treatment in alignment with the Food and Drug Administration’s (FDA) Project Optimus initiative.
The AIPAC-003 trial comprises an open-label, dose-optimisation lead-in phase (Phase II), followed by a double-blind, randomised, placebo-controlled Phase III trial.
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By GlobalDataThe primary goals of Phase II are to assess and compare the safety and tolerability of the 30mg and 90mg of efti plus paclitaxel and to establish the OBD for the Phase III portion.
Phase II is expected to last approximately 24 months while the Phase III component will begin once the OBD is defined, potentially before Phase II is fully complete.
In November last year, Immutep expanded the INSIGHT-003 trial of efti plus anti-PD-1 therapy Keytruda (pembrolizumab) and doublet chemotherapy (carboplatin and pemetrexed) to treat non-squamous non-small cell lung cancer (NSCLC) to four sites in Germany.
The sites comprise the Lung Clinic Cologne-Merheim and the University Clinic of Ruhr Universität Bochum.
This site expansion is part of the company’s plan to expedite subject enrolment in the trial.
