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Immutep Announces Initiation of TACTI-004 Phase III Trial in First Line Non-Small Cell Lung Cancer SYDNEY, AUSTRALIA

Key Takeaway: Immutep Limited has announced the initiation of the TACTI-004 Phase III clinical trial for first-line metastatic non-small cell lung cancer (NSCLC). The trial, which has received regulatory approval from the Australian Therapeutic Goods Administration, aims to evaluate the efficacy of eftilagimod alfa in combination with KEYTRUDA and chemotherapy. The study will involve approximately 750 patients across over 150 clinical sites worldwide, with expectations to enroll the first patient by the first quarter of 2025. Immutep is optimistic that this trial will significantly impact treatment options for lung cancer patients.

Market Sentiment Analysis

POSITIVE FACTORS

  • Initiation of pivotal TACTI-004 trial is a significant milestone.
  • Regulatory approval from the TGA marks a transformation for Immutep.
  • Eftilagimod alfa has potential to establish a new standard of care.
  • Strong confidence expressed in the impact of the treatment on patient lives.

Full Press Release Details

Immutep Announces Initiation of TACTI-004 Phase III Trial
in First Line Non-Small Cell Lung Cancer
SYDNEY, AUSTRALIA December 10, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a
clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the initiation of the pivotal TACTI-004
Phase III clinical trial for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC).
The receipt of regulatory approval from the Australian Therapeutic Goods Administration to commence the
TACTI-004 trial is a significant milestone for Immutep and marks its transformation into a Phase III company. This also represents a key step towards potentially establishing a new standard of care for
patients with metastatic NSCLC. We are confident based on the strength of eftilagimod alfa s data that it can make a meaningful difference in cancer patients lives, and we eagerly anticipate enrolling the first patient into this important
study during the first quarter of 2025, said Marc Voigt, CEO of Immutep.
Immutep has successfully completed regulatory submissions to the vast
majority of the more than 25 countries that will be part of the global TACTI-004 trial. Australia represents the first approval by all regulatory authorities including ethics committees and Institutional
Review Boards (IRB). The Company also anticipates full approval in the United Kingdom shortly as it has received clearances from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). Additional
approvals from multiple countries are expected in the weeks and months ahead.
The registrational TACTI-004 Phase
III trial will evaluate eftilagimod alfa, a soluble LAG-3 protein that activates dendritic cells, in combination with MSD s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy compared to KEYTRUDA in combination with chemotherapy and placebo in ~750 metastatic 1L
NSCLC patients, regardless of PD-L1 expression. The 1:1 randomized, double-blind, multinational, controlled study, with dual primary endpoints of progression-free survival and overall survival, will include
over 150 clinical sites in over 25 countries across the globe.
The Company expects to enrol the first patient in Q1 of CY2025.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of
Merck & Co., Inc., Rahway, NJ, USA.
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune
disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio
harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information,
please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Sodali & Co.
Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
This announcement was authorised for release by the CEO of Immutep Limited.
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia

Frequently Asked Questions

What is the TACTI-004 Phase III trial?

The TACTI-004 trial is a pivotal Phase III study for treating first-line metastatic NSCLC.

When did Immutep announce the TACTI-004 trial initiation?

Immutep announced the trial initiation on December 10, 2024.

What is the therapy being tested in TACTI-004?

The trial tests eftilagimod alfa with KEYTRUDA and chemotherapy against KEYTRUDA alone.

How many countries will participate in TACTI-004?

The trial will involve over 25 countries across the globe.

When is the first patient expected to be enrolled?

The first patient is expected to be enrolled in Q1 of CY2025.

Last updated: Dec 10, 2024