(RTTNews) - Immutep Limited (IMMP), a clinical-stage biotechnology company focused on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, on Tuesday announced the initiation of its pivotal TACTI-004 Phase III clinical trial for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). The trial will evaluate the company's lead drug candidate, eftilagimod alfa, in combination with Merck's KEYTRUDA (pembrolizumab) and chemotherapy. The primary endpoints are progression-free survival and overall survival.
On July 22, 2024, Immutep received positive feedback from the US FDA regarding the planned TACTI-004 Phase III trial of eftilagimod alfa (efti) in combination with KEYTRUDA (pembrolizumab) and platinum-based chemotherapy for first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.
The TACTI-004 trial follows the successful regulatory approval from the Australian Therapeutic Goods Administration (TGA) and marks a significant milestone for Immutep.
This trial aims to potentially establish eftilagimod alfa as a new standard of care in metastatic NSCLC, and the company expects to enroll the first patient in the first quarter of 2025.
Over 25 countries will be part of the global TACTI-004 trial and Immutep has successfully submitted regulatory filings in most of these regions.
Immutep had cash, cash equivalent and term deposits of A$172.3 million as of Sep.30, 2024.
IMMP is currently trading at $2.12, down 2.75%.
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