Immutep (NASDAQ: IMMP) has reported impressive results from its INSIGHT-003 trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA® and chemotherapy for first-line non-small cell lung cancer (NSCLC). The treatment achieved a 60.8% overall response rate and 90.2% disease control rate across all PD-L1 expression levels. Notably, ~92% of evaluable patients had PD-L1 TPS <50%, including 43% with PD-L1 below 1%. The combination showed significant improvements compared to historical controls, particularly in patients with lower PD-L1 expression: 75.0% vs 62.1% in high PD-L1, 64.0% vs 49.2% in low PD-L1, and 54.5% vs 32.3% in negative PD-L1 expression. The safety profile remains favorable with no new safety signals. Additional data updates are expected at a medical conference later in 2025.
Immutep (NASDAQ: IMMP) ha riportato risultati impressionanti dal suo studio INSIGHT-003 che valuta eftilagimod alfa (efti) in combinazione con KEYTRUDA® e chemioterapia per il trattamento di prima linea del carcinoma polmonare non a piccole cellule (NSCLC). Il trattamento ha raggiunto un tasso di risposta globale del 60,8% e un tasso di controllo della malattia del 90,2% in tutti i livelli di espressione di PD-L1. In particolare, circa il 92% dei pazienti valutabili presentava un TPS di PD-L1 inferiore al 50%, inclusi il 43% con PD-L1 sotto l'1%. La combinazione ha mostrato miglioramenti significativi rispetto ai controlli storici, soprattutto nei pazienti con bassa espressione di PD-L1: 75,0% vs 62,1% per PD-L1 alto, 64,0% vs 49,2% per PD-L1 basso e 54,5% vs 32,3% per espressione negativa di PD-L1. Il profilo di sicurezza rimane favorevole senza nuovi segnali di sicurezza. Ulteriori aggiornamenti sui dati sono previsti in una conferenza medica nel corso del 2025.
Immutep (NASDAQ: IMMP) ha informado resultados impresionantes de su ensayo INSIGHT-003 que evalúa eftilagimod alfa (efti) en combinación con KEYTRUDA® y quimioterapia para el cáncer de pulmón no microcítico (CPNM) de primera línea. El tratamiento alcanzó una tasa de respuesta global del 60,8% y una tasa de control de la enfermedad del 90,2% en todos los niveles de expresión de PD-L1. Notablemente, aproximadamente el 92% de los pacientes evaluables tenían un TPS de PD-L1 inferior al 50%, incluyendo un 43% con PD-L1 por debajo del 1%. La combinación mostró mejoras significativas en comparación con controles históricos, especialmente en pacientes con expresión baja de PD-L1: 75,0% vs 62,1% en PD-L1 alto, 64,0% vs 49,2% en PD-L1 bajo y 54,5% vs 32,3% en expresión negativa de PD-L1. El perfil de seguridad sigue siendo favorable sin nuevas señales de seguridad. Se esperan actualizaciones adicionales de datos en una conferencia médica a finales de 2025.
Immutep (NASDAQ: IMMP)는 1차 비소세포폐암(NSCLC) 치료를 위한 eftilagimod alpha(efti)와 KEYTRUDA® 및 화학요법 병용요법을 평가한 INSIGHT-003 임상시험에서 인상적인 결과를 보고했습니다. 이 치료법은 모든 PD-L1 발현 수준에서 전체 반응률 60.8%와 질병 조절률 90.2%를 달성했습니다. 특히 평가 가능한 환자의 약 92%가 PD-L1 TPS 50% 미만이었으며, 그 중 43%는 PD-L1 1% 미만이었습니다. 이 병용요법은 역사적 대조군과 비교해 특히 낮은 PD-L1 발현 환자에서 유의미한 개선을 보였습니다: 고 PD-L1군에서 75.0% 대 62.1%, 저 PD-L1군에서 64.0% 대 49.2%, 음성 PD-L1 발현군에서 54.5% 대 32.3%로 나타났습니다. 안전성 프로파일은 새로운 안전성 신호 없이 여전히 우수한 상태를 유지하고 있습니다. 추가 데이터 업데이트는 2025년 후반 의료 학회에서 발표될 예정입니다.
Immutep (NASDAQ : IMMP) a annoncé des résultats impressionnants issus de son essai INSIGHT-003 évaluant eftilagimod alpha (efti) en combinaison avec KEYTRUDA® et une chimiothérapie pour le traitement de première ligne du cancer du poumon non à petites cellules (NSCLC). Le traitement a atteint un taux de réponse globale de 60,8% et un taux de contrôle de la maladie de 90,2% tous niveaux d'expression de PD-L1 confondus. Notamment, environ 92 % des patients évaluables présentaient un TPS PD-L1 inférieur à 50 %, dont 43 % avec un PD-L1 inférieur à 1 %. La combinaison a montré des améliorations significatives par rapport aux témoins historiques, particulièrement chez les patients avec une faible expression de PD-L1 : 75,0 % vs 62,1 % pour une expression élevée, 64,0 % vs 49,2 % pour une expression faible, et 54,5 % vs 32,3 % pour une expression négative de PD-L1. Le profil de sécurité reste favorable sans nouveaux signaux de sécurité. Des mises à jour supplémentaires des données sont attendues lors d'une conférence médicale fin 2025.
Immutep (NASDAQ: IMMP) hat beeindruckende Ergebnisse aus der INSIGHT-003-Studie berichtet, in der eftilagimod alpha (efti) in Kombination mit KEYTRUDA® und Chemotherapie zur Erstlinientherapie des nicht-kleinzelligen Lungenkarzinoms (NSCLC) untersucht wurde. Die Behandlung erzielte eine Gesamtansprechrate von 60,8% und eine Erkrankungskontrollrate von 90,2% über alle PD-L1-Expressionsniveaus hinweg. Bemerkenswert ist, dass etwa 92% der auswertbaren Patienten einen PD-L1 TPS von unter 50% hatten, darunter 43% mit PD-L1 unter 1%. Die Kombination zeigte im Vergleich zu historischen Kontrollen signifikante Verbesserungen, insbesondere bei Patienten mit niedriger PD-L1-Expression: 75,0% vs. 62,1% bei hoher PD-L1-Expression, 64,0% vs. 49,2% bei niedriger PD-L1-Expression und 54,5% vs. 32,3% bei negativer PD-L1-Expression. Das Sicherheitsprofil bleibt günstig ohne neue Sicherheitssignale. Weitere Datenupdates werden auf einer medizinischen Konferenz Ende 2025 erwartet.
Positive
High overall response rate of 60.8% and disease control rate of 90.2% across all PD-L1 expression levels
Significant improvement compared to historical controls, especially in patients with lower PD-L1 expression
Strong efficacy in hard-to-treat patient population (92% of patients with PD-L1 TPS <50%)
Favorable safety profile with no new safety signals
Data from 165 patients across two trials showing consistent improvements in response rates
Negative
Additional trial data updates pending until later in 2025
Small sample size for high PD-L1 expression group (only 4 patients)
Insights
Immutep's triple therapy shows impressive response rates for lung cancer patients, particularly benefiting underserved PD-L1 low expressors.
The INSIGHT-003 trial results represent a significant clinical advancement in first-line NSCLC treatment. The triple combination of efti (eftilagimod alpha), pembrolizumab, and chemotherapy achieved a 60.8% overall response rate and 90.2% disease control rate across all patients - substantially outperforming historical controls.
What's particularly striking is the efficacy in typically hard-to-treat patient populations. About 92% of enrolled patients had PD-L1 expression below 50%, including 43% with PD-L1 below 1%. These patients with low PD-L1 expression traditionally respond poorly to immunotherapy. Yet this combination showed a 59.6% response rate in PD-L1 <50% patients compared to historical 40.8%.
The most remarkable improvement was seen in PD-L1 negative (<1%) patients, where the triple therapy achieved 54.5% ORR versus historical 32.3% - a 68.7% relative improvement. This suggests efti effectively sensitizes these traditionally immunotherapy-resistant tumors.
The favorable safety profile further strengthens the clinical potential. These results validate the design of the pivotal TACTI-004 Phase III trial using the same combination and strongly suggest efti could establish a new standard of care, particularly for the majority of NSCLC patients with low PD-L1 expression who currently have limited treatment options.
Novel combination achieves 60.8% response rate and 90.2% disease control rate in first-line non-small cell lung cancer (1L NSCLC)
Notably, ~92% of all evaluable patients have PD-L1 TPS <50%, including 43% with PD-L1 below 1 (TPS <1%), who represent an area of high unmet need
Data demonstrates significant improvement in response rates compared to historical controls, and safety continues to be favourable
Multi-centre INSIGHT-003 is evaluating the same immunotherapy/chemotherapy combination used in the pivotal TACTI-004 Phase III in 1L NSCLC
Additional data from INSIGHT-003 is planned for presentation at a medical conference later this year
SYDNEY, AUSTRALIA, May 15, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).
Marc Voigt, CEO of Immutep, stated, “Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy. In multi-national settings, efti has generated consistent and remarkable improvements in response rates. In particular, the interim ORR data in patients with PD-L1 expression below 50% in the ongoing INSIGHT-003 trial, who represent over two-thirds of the 1L NSCLC patient population, is very encouraging.”
Majority of Patients have PD-L1 TPS <50% Notably, ~92% of all evaluable patients (N=51) in the INSIGHT-003 study have PD-L1 TPS <50%. This includes 49% of patients with PD-L1 Tumour Proportion Score (TPS) of 1-49% and 43% of patients with PD-L1 TPS <1%, as shown in the table below.
Strong Response Rates Across All PD-L1 Expression Levels Data from all evaluable patients demonstrates significant improvement of Overall Response Rate (ORR) according to RECIST 1.1 across all levels of PD-L1 expression compared to historical control from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC1:
75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS >50%)
64.0% ORR versus 49.2% ORR in patients with low PD-L1 expression (TPS 1-49%)
54.5% ORR versus 32.3% ORR in patients with negative PD-L1 expression (TPS <1%)
The 60.8% response rate regardless of PD-L1 expression (TPS 0-100%) represents a substantial improvement compared to historical control of 48.0%.1 The relative outperformance is particularly strong given the registrational trial has four times as many patients with high PD-L1 expression (~32% of patients versus ~8% in INSIGHT-003), who have the highest response rates.
Importantly, in patients with TPS <50% (N=47), who have a high unmet need and represent over two-thirds of the 1L NSCLC patient populaton, the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8%.1
INSIGHT-003 Overall Response Rate & Disease Control Rate, according to RECIST1.1
PD-L1 Expression Levels
TPS 0-100% (N=51)
TPS <1% (N=22)
TPS 1-49% (N=25)
TPS <50% (N=47)
TPS ≥50% (N=4)
ORR %
60.8
54.5
64.0
59.6
75.0
DCR %
90.2
86.4
92.0
89.4
100
Safety Safety continues to be favourable for the triple combination in 1L NSCLC with no new safety signals.
Next Steps Additional data updates from this trial are expected to be presented at a medical conference in 2025 and beyond.
About INSIGHT-003 INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF and several other German centres. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in front-line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.
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 late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s 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.
1. Shirish Gadgeel et al., Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer. JCO 38, 1505-1517(2020). DOI:10.1200/JCO.19.03136
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
U.S. Media: Chris Basta, VP, Investor Relations and Corporate Communications +1 (631) 318 4000; chris.basta@immutep.com
FAQ
What are the response rates achieved by IMMP's efti combination therapy in first-line NSCLC?
The combination therapy achieved a 60.8% overall response rate and 90.2% disease control rate across all PD-L1 expression levels in first-line NSCLC patients.
How does IMMP's treatment perform in patients with low PD-L1 expression?
In patients with PD-L1 TPS <50%, the treatment achieved a 59.6% response rate compared to historical control of 40.8%, showing significant improvement in this hard-to-treat population.
What is the safety profile of Immutep's efti combination therapy?
The safety profile continues to be favorable for the triple combination therapy in first-line NSCLC with no new safety signals reported.
How many patients were included in IMMP's INSIGHT-003 trial?
The trial included 51 evaluable patients, with approximately 92% having PD-L1 TPS <50%, including 43% with PD-L1 below 1%.
When will additional data from IMMP's INSIGHT-003 trial be presented?
Additional data updates from the trial are expected to be presented at a medical conference later in 2025.
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