Media Launch
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Remaining dialogue with the FDA, efficiently concluding the regulatory preparations for the TACTI-004 Part III trial design to judge efti together with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 remedy, and customary chemotherapy in first-line non-small cell lung most cancers
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TACTI-004 registrational trial will enrol ~750 sufferers no matter PD-L1 expression as a way to deal with the complete 1L NSCLC market eligible for anti-PD-1 remedy
SYDNEY, AUSTRALIA, July 22, 2024 (GLOBE NEWSWIRE) — Immutep Restricted (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Firm”), a clinical-stage biotechnology firm creating novel LAG-3 immunotherapies for most cancers and autoimmune illness, at this time proclaims that constructive suggestions has been obtained from the US Meals and Drug Administration (“FDA”) relating to the deliberate TACTI-004 Part III trial of eftilagimod alfa (“efti”) together with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 remedy, and histology-based platinum doublet chemotherapy for the remedy of first-line metastatic non-small cell lung most cancers (1L NSCLC), no matter PD-L1 expression.
The FDA suggestions from this Sort C assembly, together with suggestions beforehand obtained from the Paul-Ehrlich-Institut (“PEI”) and the Spanish Company for Medicines and Well being Merchandise (“AEMPS”), concludes the preparatory regulatory interactions for the design of this registrational trial. This marks a big step ahead to develop an efficient remedy for non-squamous and squamous 1L NSCLC sufferers who’ve excessive, low, or no PD-L1 expression and are eligible for anti-PD-1 remedy.
The TACTI-004 Part III trial, which can enrol ~750 sufferers, is predicated on the constructive efficacy and security knowledge in 1L NSCLC generated from the TACTI-002 Part II and INSIGHT-003 trials.
“We’re happy with the FDA’s suggestions as this enables us to efficiently conclude our regulatory preparation for the TACTI-004 registrational trial. This represents a key milestone in our late-stage growth course of for efti centred on probably driving a brand new customary of care globally within the remedy of non-small cell lung most cancers. We hope to attain this by means of efti together with KEYTRUDA, which has led to robust efficacy knowledge with a beneficial security profile in 1L NSCLC sufferers no matter PD-L1 expression,” said Christian Mueller, Immutep’s SVP, Regulatory and Technique.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
TACTI-004 (Two ACTive Immunotherapies-004) Registrational Part III Trial Design
TACTI-004 can be a 1:1 randomized, double-blind, multinational, managed scientific trial to judge Immutep’s efti together with KEYTRUDA and customary chemotherapy in comparison with the standard-of-care, KEYTRUDA together with chemotherapy and placebo in first-line metastatic non-small cell lung most cancers (NSCLC), no matter PD-L1 expression. On this pivotal PD-L1 all comer trial, the twin main endpoints can be progression-free and total survival with a prespecified futility boundary and a pre-planned interim evaluation. The trial can be performed globally and enrol roughly 750 NSCLC sufferers (together with each squamous and non-squamous subtypes).
About Eftilagimod Alfa (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates each innate and adaptive immunity for the remedy of most cancers. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (main histocompatibility advanced) Class II molecules on APC resulting in activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It additionally upregulates the expression of key organic molecules like IFN-ƴ and CXCL10 that additional enhance the immune system’s capability to battle most cancers.
Efti is underneath analysis for a wide range of stable tumours together with non-small cell lung most cancers (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast most cancers. Its beneficial security profile permits varied combos, together with with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has obtained Quick Monitor designation in first line HNSCC and in first line NSCLC from the US Meals and Drug Administration (FDA).
About Immutep
Immutep is a clinical-stage biotechnology firm creating novel LAG-3 immunotherapy for most cancers and autoimmune illness. We’re pioneers within the understanding and development of therapeutics associated to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its distinctive capability to stimulate or suppress the immune response. Immutep is devoted to leveraging its experience to convey progressive remedy choices to sufferers in want and to maximise worth for shareholders. For extra data, please go to www.immutep.com.
Australian Traders/Media:
Catherine Robust, Morrow Sodali
+61 (0)406 759 268; c.robust@morrowsodali.com
U.S. Traders/Media:
Chris Basta, VP, Investor Relations and Company Communications
+1 (631) 318 4000; chris.basta@immutep.com
