Immutep announces results of FDA meeting on eftilagimod alpha

Immutep announces the results of a positive follow-up Type C meeting with the US Food and Drug Administration regarding late-stage clinical development plans for its first-in-class soluble LAG-3 protein, eftilagimod alpha, in conjunction with standard-of-care chemotherapy for the treatment of metastatic breast cancer. The Company and the FDA have agreed to an integrated Phase II/III trial design that will help inform a Biologics License Application. Based on the encouraging efficacy, favourable safety, and learnings from the randomised AIPAC Phase IIb trial,patients will receive efti and paclitaxel on the same day and treatment will continue until disease progression. The patient population has also been expanded to include triple-negative breast cance, an aggressive form of breast cancer with limited treatment options. Immutep CEO, Marc Voigt, commented: "As recently announced, our late-stage clinical development efforts for efti are now focused on frontline NSCLC in combination with anti-PD-1 therapy, given the large market opportunity and need for more durable and tolerable options. With this said, progress reported to date with the FDA and EMA provides Immutep and its potential partners flexibility for late-stage clinical development of efti plus standard-of-care chemotherapy to address the high unmet need for metastatic breast cancer patients, while maintaining their quality of life as was shown in the AIPAC trial." FDA have agreed to test 90mg efti dosing in combination with paclitaxel driven predominantly by the safety profile of the AIPAC Phase IIb trial, along with the FDA’s Project Optimus initiative in oncology.