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

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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.

Immutep (NASDAQ: IMMP) ha avviato il fondamentale studio clinico di Fase III TACTI-004 per il trattamento del cancro al polmone non a piccole cellule metastatico in prima linea. Lo studio ha ricevuto l'approvazione normativa dall'Agenzia Australiana per i Farmaci e i Prodotti Sanitari, segnando un avanzamento della società allo stato di Fase III.

Lo studio globale valuterà eftilagimod alfa in combinazione con KEYTRUDA® e chemioterapia rispetto a KEYTRUDA con chemioterapia e placebo. Il trial coinvolgerà circa 750 pazienti in oltre 150 siti clinici in più di 25 paesi. Lo studio randomizzato e in doppio cieco presenta due obiettivi primari: la sopravvivenza libera da progressione e la sopravvivenza globale. Il reclutamento del primo paziente è previsto per il primo trimestre del 2025.

Immutep (NASDAQ: IMMP) ha comenzado el importante ensayo clínico TACTI-004 de Fase III para el tratamiento del cáncer de pulmón no microcítico metastásico en primera línea. El ensayo recibió la aprobación regulatoria de la Administración de Bienes Terapéuticos de Australia, marcando el avance de la compañía al estado de Fase III.

El estudio global evaluará eftilagimod alfa en combinación con KEYTRUDA® y quimioterapia en comparación con KEYTRUDA más quimioterapia y placebo. El ensayo involucrará aproximadamente a 750 pacientes en más de 150 sitios clínicos en más de 25 países. El estudio es aleatorizado y doble ciego, con dos objetivos primarios: la supervivencia libre de progresión y la supervivencia global. Se espera que la inscripción del primer paciente ocurra en el primer trimestre de 2025.

Immutep (NASDAQ: IMMP)가 1차 전이성 비소세포 폐암 치료를 위한 주요 TACTI-004 3상 임상시험을 시작했습니다. 이 시험은 호주 의약품 및 생물학적 제제 관리국의 규제 승인을 받았으며, 이는 회사가 3상으로 진행됨을 의미합니다.

이번 글로벌 연구는 eftilagimod alfa를 KEYTRUDA®와 화학요법의 조합으로 평가하며, KEYTRUDA와 화학요법, 그리고 위약과 비교합니다. 연구에는 25개 이상의 국가에서 150개 이상의 임상 사이트에서 약 750명의 환자가 참여할 것입니다. 이 무작위 이중 맹검 연구는 진전 없는 생존과 전체 생존의 두 가지 주요 목표를 가지고 있습니다. 첫 번째 환자 등록은 2025년 1분기에 있을 것으로 예상됩니다.

Immutep (NASDAQ: IMMP) a lancé l'essai clinique pivot TACTI-004 Phase III pour le traitement du cancer du poumon non à petites cellules métastatique de première ligne. L'essai a reçu l'approbation réglementaire de l'Administration australienne des produits thérapeutiques, marquant l'avancement de l'entreprise vers le statut de phase III.

Cette étude mondiale évaluera eftilagimod alfa en combinaison avec KEYTRUDA® et une chimiothérapie, par rapport à KEYTRUDA avec chimiothérapie et placebo. L'essai impliquera environ 750 patients à travers plus de 150 sites cliniques dans plus de 25 pays. L'étude randomisée en double aveugle comporte deux objectifs principaux : la survie sans progression et la survie globale. L'inscription du premier patient est prévue pour le premier trimestre 2025.

Immutep (NASDAQ: IMMP) hat die wichtige TACTI-004 Phase III-Studie zur Behandlung von metastasierendem nicht-kleinzelligem Lungenkrebs in der Erstlinientherapie initiiert. Die Studie erhielt die zulassungsrechtliche Genehmigung von der Therapeutic Goods Administration Australiens, was den Fortschritt des Unternehmens zum Phase III-Status markiert.

Die globale Studie wird eftilagimod alfa in Kombination mit KEYTRUDA® und Chemotherapie gegen KEYTRUDA mit Chemotherapie und Placebo untersuchen. An der Studie werden voraussichtlich etwa 750 Patienten an über 150 klinischen Standorten in mehr als 25 Ländern teilnehmen. Die randomisierte, doppelblinde Studie hat zwei primäre Endpunkte: das progressionsfreie Überleben und das Gesamtüberleben. Die Einschreibung des ersten Patienten wird für das erste Quartal 2025 erwartet.

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

Insights

The initiation of TACTI-004, a Phase III trial for first-line NSCLC treatment, represents a significant advancement in Immutep's clinical development program. The trial's design is particularly robust, featuring 750 patients across 150 clinical sites in 25 countries, with dual primary endpoints of progression-free and overall survival. The combination therapy approach, testing eftilagimod alfa with KEYTRUDA and chemotherapy, targets a broad NSCLC patient population regardless of PD-L1 expression. This could potentially address current treatment gaps and expand therapeutic options. The Australian regulatory approval and pending UK clearances demonstrate strong regulatory momentum. The trial's global scale and partnership with MSD enhance its credibility and potential market impact.

This Phase III trial initiation marks a pivotal moment for Immutep, signaling its evolution into a late-stage biotechnology company. With a market cap of $308M, successful progression through this trial could significantly enhance the company's valuation. The partnership with MSD (Merck) adds substantial credibility and reduces development risks. The global scope of the trial, spanning 25 countries, suggests strong commercial potential if approved. The broad patient inclusion criteria, independent of PD-L1 expression, could translate to a larger addressable market in the lucrative NSCLC space. The Q1 2025 enrollment timeline provides a clear catalyst for investors to monitor. The company's transformation into a Phase III organization could attract increased institutional investor interest and potential partnership opportunities.

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.

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