Immutep Announces Successful Meeting with FDA on Phase III Design in Non-Small Cell Lung Cancer
Immutep (NASDAQ: IMMP) has successfully concluded regulatory preparations for its TACTI-004 Phase III trial design, following positive feedback from the FDA. The trial will evaluate eftilagimod alfa (efti) in combination with KEYTRUDA® (pembrolizumab) and standard chemotherapy for first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.
Key points:
- Trial will enroll ~750 patients
- Targets entire 1L NSCLC market eligible for anti-PD-1 therapy
- Based on positive data from TACTI-002 Phase II and INSIGHT-003 trials
- Dual primary endpoints: progression-free and overall survival
- 1:1 randomized, double-blind, multinational, controlled design
- Includes both squamous and non-squamous NSCLC subtypes
Immutep (NASDAQ: IMMP) ha concluso con successo i preparativi regolatori per il design del suo trial di Fase III TACTI-004, a seguito di un riscontro positivo da parte della FDA. Il trial valuterà eftilagimod alfa (efti) in combinazione con KEYTRUDA® (pembrolizumab) e chemioterapia standard per il cancro ai polmoni non a piccole cellule metastatici di prima linea (1L NSCLC), indipendentemente dall'espressione di PD-L1.
Punti chiave:
- Il trial arruolerà circa 750 pazienti
- Si rivolge all'intero mercato 1L NSCLC idoneo per la terapia anti-PD-1
- Basato su dati positivi dai trial TACTI-002 di Fase II e INSIGHT-003
- Obiettivi primari doppi: sopravvivenza libera da progressione e sopravvivenza complessiva
- Design randomizzato 1:1, in doppio cieco, multinazionale e controllato
- Include sia sottotipi squamosi che non squamosi di NSCLC
Immutep (NASDAQ: IMMP) ha concluido con éxito los preparativos regulatorios para el diseño de su ensayo TACTI-004 de Fase III, tras recibir comentarios positivos de la FDA. El ensayo evaluará eftilagimod alfa (efti) en combinación con KEYTRUDA® (pembrolizumab) y quimioterapia estándar para el cáncer de pulmón no microcítico metastásico de primera línea (1L NSCLC), sin importar la expresión de PD-L1.
Puntos clave:
- El ensayo incluirá aproximadamente 750 pacientes
- Apunta a todo el mercado 1L NSCLC elegible para terapia anti-PD-1
- Basado en datos positivos de los ensayos TACTI-002 de Fase II e INSIGHT-003
- Objetivos primarios dobles: supervivencia libre de progresión y supervivencia general
- Diseño aleatorio 1:1, doble ciego, multinacional y controlado
- Incluye tanto subtipos de NSCLC escamoso como no escamoso
Immutep (NASDAQ: IMMP)는 FDA의 긍정적인 피드백을 받은 후 TACTI-004 3상 시험 설계를 위한 규제 준비를 성공적으로 마쳤습니다. 이 시험은 eftilagimod alfa (efti)와 KEYTRUDA® (펨브롤리주맙), 그리고 표준 화학요법을 조합하여 1차 전이 비소세포 폐암(1L NSCLC)을 평가할 것입니다. PD-L1 발현 여부에 관계없이 진행됩니다.
주요 사항:
- 시험은 약 750명의 환자를 등록할 예정입니다.
- 항-PD-1 치료에 적합한 전체 1L NSCLC 시장을 목표로 합니다.
- TACTI-002 2상 및 INSIGHT-003 시험의 긍정적인 데이터를 기반으로 합니다.
- 주요 2가지 종료점: 무진행 생존 및 전체 생존
- 1:1 무작위 배정, 이중 맹검, 다국적, 통제된 디자인입니다.
- 편평세포 및 비편평세포 NSCLC 아형 모두를 포함합니다.
Immutep (NASDAQ: IMMP) a réussi à finaliser les préparatifs réglementaires pour le design de son essai TACTI-004 de Phase III, suite à des retours positifs de la FDA. L'essai évaluera eftilagimod alfa (efti) en association avec KEYTRUDA® (pembrolizumab) et la chimiothérapie standard pour le cancer du poumon non à petites cellules métastatique de première ligne (1L NSCLC), indépendamment de l'expression de PD-L1.
Points clés :
- L'essai recrutera environ 750 patients
- Cible l'ensemble du marché 1L NSCLC éligible à la thérapie anti-PD-1
- Basé sur des données positives des essais TACTI-002 de Phase II et INSIGHT-003
- Objectifs primaires doubles : survie sans progression et survie globale
- Design randomisé 1:1, en double aveugle, multinational et contrôlé
- Inclut à la fois les sous-types NSCLC squameux et non squameux
Immutep (NASDAQ: IMMP) hat erfolgreich die regulatorischen Vorbereitungen für das Design seiner TACTI-004 Phase III Studie abgeschlossen, nachdem es positives Feedback von der FDA erhalten hat. Die Studie wird eftilagimod alfa (efti) in Kombination mit KEYTRUDA® (Pembrolizumab) und Standard-Chemotherapie für erstlinige metastasierte nicht-kleinzellige Lungenkrebs (1L NSCLC) bewerten, unabhängig von der PD-L1-Expression.
Wichtige Punkte:
- Die Studie wird etwa 750 Patienten einschließen
- Zielt auf den gesamten 1L NSCLC-Markt ab, der für die Anti-PD-1-Therapie geeignet ist
- Basierend auf positiven Daten aus den TACTI-002 Phase II und INSIGHT-003 Studien
- Duale primäre Endpunkte: progressionsfreie und allgemeine Überlebenszeit
- Randomisiertes 1:1, doppelblind, multinationales, kontrolliertes Design
- Beinhaltet sowohl plättchen- als auch nicht-plättchenspezifische NSCLC-Subtypen
- FDA provided positive feedback on TACTI-004 Phase III trial design
- Trial targets a broad patient population, including all PD-L1 expression levels
- Based on positive efficacy and safety data from previous trials
- Large-scale trial with ~750 patients planned
- Potential to establish a new standard of care in 1L NSCLC treatment
- None.
Insights
The FDA's feedback on the TACTI-004 Phase III trial is a important milestone for Immutep's efforts in addressing first-line non-small cell lung cancer (NSCLC). From a clinical perspective, the combination of efti and KEYTRUDA, irrespective of PD-L1 expression, presents a promising therapeutic strategy. This is particularly significant as it includes patients with varying PD-L1 levels, potentially enhancing treatment accessibility and efficacy.
The trial design also emphasizes robust endpoints like progression-free survival and overall survival, essential for assessing the treatment's impact comprehensively. The previous positive results from Phase II trials bolster the confidence in moving forward with this extensive patient cohort in Phase III.
The FDA's endorsement is a pivotal event for Immutep, likely to bolster investor confidence and support higher valuations. The approval to proceed with a Phase III trial involving roughly 750 patients signals the potential for significant revenue streams if the trial is successful. Given the competitive landscape of NSCLC treatments, entering first-line therapy with positive interim results could drive substantial market share gains.
Furthermore, the combination with KEYTRUDA, a well-established therapy, reduces some commercial risks and may expedite market penetration. Investors should closely monitor upcoming trial milestones and interim analyses, which could serve as critical catalysts for stock performance.
This development places Immutep in a strong competitive position within the NSCLC treatment market, which is projected to reach significant heights due to the increasing prevalence of lung cancer globally. The trial's inclusive design, catering to a broad spectrum of PD-L1 expressions, allows Immutep to target a larger patient demographic than many existing therapies.
The dual primary endpoints of progression-free and overall survival are strategic, as they align with the primary concerns of both patients and healthcare providers, potentially accelerating adoption. The global nature of the trial also suggests a well-planned strategy for rapid market entry and wide geographical reach upon approval.
Media Release
- Final discussion with the FDA, successfully concluding the regulatory preparations for the TACTI-004 Phase III trial design to evaluate efti in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, and standard chemotherapy in first-line non-small cell lung cancer
- TACTI-004 registrational trial will enrol ~750 patients regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapy
SYDNEY, AUSTRALIA, July 22, 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 that positive feedback has been received from the US Food and Drug Administration (“FDA”) regarding the planned TACTI-004 Phase III trial of eftilagimod alfa (“efti”) in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.
The FDA feedback from this Type C meeting, along with feedback previously received from the Paul-Ehrlich-Institut (“PEI”) and the Spanish Agency for Medicines and Health Products (“AEMPS”), concludes the preparatory regulatory interactions for the design of this registrational trial. This marks a significant step forward to develop an effective treatment for non-squamous and squamous 1L NSCLC patients who have high, low, or no PD-L1 expression and are eligible for anti-PD-1 therapy.
The TACTI-004 Phase III trial, which will enrol ~750 patients, is based on the positive efficacy and safety data in 1L NSCLC generated from the TACTI-002 Phase II and INSIGHT-003 trials.
“We are pleased with the FDA’s feedback as this allows us to successfully conclude our regulatory preparation for the TACTI-004 registrational trial. This represents a key milestone in our late-stage development process for efti centred on potentially driving a new standard of care globally in the treatment of non-small cell lung cancer. We hope to achieve this through efti in combination with KEYTRUDA, which has led to strong efficacy data with a favourable safety profile in 1L NSCLC patients regardless of PD-L1 expression,” stated Christian Mueller, Immutep’s SVP, Regulatory and Strategy.
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 Phase III Trial Design
TACTI-004 will be a 1:1 randomized, double-blind, multinational, controlled clinical trial to evaluate Immutep’s efti in combination with KEYTRUDA and standard chemotherapy compared to the standard-of-care, KEYTRUDA in combination with chemotherapy and placebo in first-line metastatic non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. In this pivotal PD-L1 all comer trial, the dual primary endpoints will be progression-free and overall survival with a prespecified futility boundary and a pre-planned interim analysis. The trial will be conducted globally and enrol approximately 750 NSCLC patients (including both 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 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-ƴ 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).
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, Morrow Sodali
+61 (0)406 759 268; c.strong@morrowsodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
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