This collaboration follows two previous collaborations for the
TACTI-002 Phase II and TACTI-003 Phase IIb trials, which collectively treated over 350 patients. Under the terms of the agreement, Immutep will conduct the
registrational TACTI-004 study and MSD will supply KEYTRUDA. The agreement enables Immutep and MSD to seek marketing authorisation of the combination and to market their respective compounds with a relevant
label indication. The parties retain the commercial rights to their respective compounds and are free to conduct other clinical studies, either individually or in combination, in any therapeutic area.
The clinical data generated by the innovative immuno-oncology combination of Immutep’s MHC Class II agonist and MSD’s anti-PD-1 therapy in the TACTI-002 Phase II trial in first-line NSCLC regardless of PD-L1
expression has led to oral presentations at the ASCO, SITC, and ESMO conferences. Efti’s unique activation of dendritic cells (the most potent professional antigen-presenting cells) engages the adaptive and innate immune system to drive a broad
anti-cancer immune response, including proliferation of cytotoxic T cells that complements anti-PD-1 therapy in first-line NSCLC across all levels of PD-L1 expression (negative, low, and high).
Notably, over 75% of the patients in both the TACTI-002 and INSIGHT-003 clinical trials had a PD-L1 Tumor Proportion Score (TPS) of <50%, and both studies have shown strong
efficacy in these patients with low and negative PD-L1 expression who are typically less responsive to anti-PD-1 therapy.
Furthermore, the triple combination of efti, KEYTRUDA and carboplatin/pemetrexed in INSIGHT-003 has been well tolerated.
“KEYTRUDA has revolutionized the treatment landscape in NSCLC and our confidence in efti’s ability to build upon its positive impact on patient
outcomes, and potentially expand the number of responding patients, stems from the compelling data in our TACTI-002 and INSIGHT-003 trials. We are excited to confirm the
differentiated efficacy and safety that we have seen to date in NSCLC via efti’s first pivotal Phase III study and TACTI-004’s robust randomized, double-blind trial design,” added Christian
Mueller, Immutep’s SVP, Regulatory and Strategy.
Lung cancer is the second most common cancer. Non-small
cell lung cancer accounts for approximately 80-85% of all lung cancers, impacting an estimated 1.87 million people annually, and is the highest cause of death among all cancers1-3.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of
Merck & Co., Inc., Rahway, NJ, USA.
About Eftilagimod Alfa (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and
adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex)
Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ϒ and CXCL10 that further boost the immune system’s ability to fight cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck
squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy
and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).