• Positive feedback for the general clinical development program including the planned registrational Phase III trial in metastatic breast cancer (MBC)
• Other regulatory engagement ongoing, including with the US Food and Drug Administration (FDA)
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, is pleased to announce it has received positive feedback from the European Medicines Agency (EMA) regarding its clinical development program for lead product candidate, eftilagimod alpha (efti), including the planned Phase III trial in MBC.
In its scientific advice the EMA has supported the Company’s view to continue the development of efti in MBC in a Phase III clinical trial, based on clinical data presented in December 2020 at SABCS. The trial will be built on the Company’s ongoing Phase IIb AIPAC trial, which reported encouraging interim results in key patient subgroup populations. Final overall survival data from the Phase IIb AIPAC trial will be reported in mid November at SITC 2021 as a late breaker poster presentation.
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