Immutep (ASX:IMM) has announced that the open-label safety lead-in of its integrated AIPAC-003 Phase 2/3 trial evaluating 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues.
The clinical-stage company is developing novel LAG-3 immunotherapies for cancer and autoimmune diseases.
The company said six patients with metastatic breast cancer receiving the immuno-oncology and chemotherapy (IO-chemo) combination, after exhaustion of all endocrine/CDK4/6 based therapies, tolerated the therapy very well, and there were no dose-limiting toxicities. This was confirmed by the independent Data Monitoring Committee (IDMC) appointed for the trial. The IDMC recommended proceeding to the randomised Phase 2 portion of the trial.
The Phase 2 portion will now open to include up to 58 evaluable patients with metastatic breast cancer receiving either 30mg efti or 90mg efti to determine the optimal biological dose.