Immutep Announces Initiation of Phase II/III Trial for
Eftilagimod Alpha plus Paclitaxel in Metastatic Breast Cancer
Immutep today announced the initiation of AIPAC-003 (Active Immunotherapy, Eftilagimod Alpha, and PAClitaxel), an integrated Phase II/III trial to evaluate eftilagimod alpha (“efti”) in combination with paclitaxel for the treatment of metastatic HER2-neg/low breast cancer (MBC). Regulatory approval has been received in the US and Institutional Review Board (IRB) approval has been received in Spain, with approvals in additional countries anticipated to follow shortly. The first patient is expected to be enrolled in early Q2 CY2023.
Highlights include:
Integrated Phase II/III trial design incorporates feedback from the FDA and EMA and will help inform a BLA and MAA
HR+/HER2-neg/low metastatic breast cancer (MBC) patient population has been expanded to include triple-negative breast cancer, which together account for ~78% of breast cancer cases
Approval for study start received in US and IRB approval in Spain, with more countries to follow shortly
First patient expected to be enrolled in early Q2 CY2023
As a first-in-class APC activator, efti is well positioned to enhance standard-of-care chemotherapy in MBC
Immutep CEO, Marc Voigt, said, “With its novel mechanism of action to activate antigen-presenting cells, efti has to date safely improved clinical outcomes from anti-PD-(L)1 therapies and standard-of-care chemotherapy. We look forward to AIPAC-003 building upon the encouraging synergy seen in our previous Phase IIb trial in metastatic breast cancer, especially with its three key adaptations: same day administration of efti plus paclitaxel, this dual IO-chemotherapy treatment continuing until disease progression, and a new primary endpoint of overall survival. The selected Phase II/III trial design allows us to move forward with a risk-balanced approach in MBC, as we continue our prioritized late-stage clinical development with anti-PD-1 therapy in 1st line head & neck squamous cell carcinoma and 1st line non-small cell lung cancer."