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

Rhea-AI Summary

Immutep (NASDAQ: IMMP) has initiated the pivotal TACTI-004 Phase III clinical trial for first-line metastatic non-small cell lung cancer treatment. The trial received regulatory approval from Australia's Therapeutic Goods Administration, marking the company's advancement to Phase III status.

The global study will evaluate eftilagimod alfa in combination with KEYTRUDA® and chemotherapy against KEYTRUDA with chemotherapy and placebo. The trial will involve approximately 750 patients across 150+ clinical sites in 25+ countries. The randomized, double-blind study features dual primary endpoints of progression-free survival and overall survival. First patient enrollment is expected in Q1 2025.

Positive

• Received first regulatory approval for Phase III trial from Australian authorities
• Expanding global presence with trial sites in over 25 countries
• Large-scale trial with approximately 750 patients
• Strategic partnership with MSD (Merck) for KEYTRUDA combination therapy
• UK regulatory approval expected shortly with MHRA and REC clearances

Negative

• First patient enrollment not expected until Q1 2025
• Significant resources required to manage 150+ clinical sites globally
• Extended timeline for multiple country approvals still pending

Media Release

SYDNEY, AUSTRALIA, Dec. 10, 2024 (GLOBE NEWSWIRE) -- 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.

About Immutep
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.
+61 (0)406 759 268; catherine.strong@sodali.com

U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com

FAQ

What is the TACTI-004 Phase III trial testing for IMMP?

The TACTI-004 trial is testing eftilagimod alfa combined with KEYTRUDA and chemotherapy for first-line metastatic non-small cell lung cancer treatment, compared to KEYTRUDA with chemotherapy and placebo.

How many patients will be enrolled in IMMP's TACTI-004 Phase III trial?

The TACTI-004 Phase III trial will enroll approximately 750 metastatic non-small cell lung cancer patients across more than 150 clinical sites globally.

When will IMMP begin patient enrollment for the TACTI-004 trial?

Immutep expects to enroll the first patient in the TACTI-004 Phase III trial during the first quarter of 2025.

Which countries have approved IMMP's TACTI-004 trial?

Australia has provided the first regulatory approval, with UK approval expected shortly. The trial will eventually span over 25 countries, with additional approvals pending.