Immutep Limited (ASX: IMM) Initiates Phase III Trial for Lung Cancer
Pivotal Trial Announcement
Immutep Limited (ASX: IMM) has initiated its pivotal TACTI-004 Phase III clinical trial for treating first-line metastatic non-small cell lung cancer (1L NSCLC). The trial marks a significant milestone for the company, indicating its transformation into a Phase III entity after receiving regulatory approval from the Australian Therapeutic Goods Administration.
Regulatory Progress
The company has completed regulatory submissions in over 25 countries participating in the global trial, with Australia being the first to gain all required approvals. Immutep anticipates receiving full approval in the United Kingdom soon, bolstered by clearances from the Medicines and Healthcare products Regulatory Agency (MHRA). Additional country approvals are expected shortly.
Study Design and Expectations
The TACTI-004 trial will assess eftilagimod alfa, a soluble LAG-3 protein, in combination with MSD’s KEYTRUDA® and chemotherapy. The study will randomly involve 750 metastatic 1L NSCLC patients, with dual primary endpoints of progression-free survival and overall survival across over 150 clinical sites globally. The company plans to enroll the first patient in the first quarter of 2025.
Regarding the trial, CEO Marc Voigt remarked, “The receipt of regulatory approval… is a significant milestone for Immutep… We are confident based on the strength of eftilagimod alfa’s data that it can make a meaningful difference in cancer patients’ lives.”
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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