SYDNEY, AUSTRALIA – 10 March 2022 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), is pleased to announce it has received constructive feedback from the US Food and Drug Administration (FDA) regarding its clinical development program for lead product candidate, eftilagimod alpha (efti or IMP321), in metastatic breast cancer (MBC).
In particular, the FDA has supported Immutep’s view to continue exploring the development of efti in MBC in a new registrational trial. The FDA’s feedback was based on clinical data presented by Immutep, including final overall survival data from its phase IIb AIPAC trial reported at the SITC 2021 conference (see announcements dated 10 and 15 November 2021).
The advice from the FDA follows the receipt of feedback from the European Medicines Agency (EMA) regarding Immutep’s clinical development program for efti, as announced in October 2021.
The planned new registrational trial, AIPAC-003, will be based on Immutep’s completed AIPAC trial, but with an optimized design and directed to patients who are likely to benefit most from the treatment. As the new trial is intended to take place across multiple countries, additional regulatory interactions are ongoing, including with the FDA and EMA. Immutep is also consulting key opinion leaders and its clinical advisory board, and will consolidate this advice with the ongoing feedback from the regulatory interactions to generate a final study design.
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