Immutep’s Efti Shows Excellent Survival Data from INSIGHT-003 Trial in Non-Small Cell Lung Cancer
Immutep (NASDAQ: IMMP) reports positive data from INSIGHT-003 Phase I trial evaluating eftilagimod alpha (efti) combined with KEYTRUDA and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer. Mature data shows median Overall Survival of 32.9 months, median Progression Free Survival of 12.7 months, and 24-month Overall Survival rate of 81.0%.
The trial demonstrated significant improvement in Overall Response Rate across all PD-L1 expression levels compared to historical controls, achieving 55.0% ORR and 87.5% Disease Control Rate. Safety profile remains favorable with no new safety signals.
Immutep (NASDAQ: IMMP) riporta dati positivi dallo studio clinico di fase I INSIGHT-003 che valuta l'eftilagimod alpha (efti) in combinazione con KEYTRUDA e chemioterapia per il trattamento di prima linea del cancro polmonare non a piccole cellule non squamoso in stadio metastatico. I dati maturi mostrano una sopravvivenza globale mediana di 32,9 mesi, una sopravvivenza libera da progressione mediana di 12,7 mesi, e un tasso di sopravvivenza globale a 24 mesi dell'81,0%.
Lo studio ha dimostrato un miglioramento significativo nel tasso di risposta globale in tutti i livelli di espressione di PD-L1 rispetto ai controlli storici, raggiungendo un ORR del 55,0% e un tasso di controllo della malattia dell'87,5%. Il profilo di sicurezza rimane favorevole senza nuovi segnali di sicurezza.
Immutep (NASDAQ: IMMP) informa sobre datos positivos del ensayo clínico de fase I INSIGHT-003 que evalúa el eftilagimod alpha (efti) combinado con KEYTRUDA y quimioterapia para el tratamiento de primera línea del cáncer de pulmón no microcítico no escamoso en etapa metastásica. Los datos maduros muestran una supervivencia global media de 32,9 meses, una supervivencia libre de progresión media de 12,7 meses y una tasa de supervivencia global a 24 meses del 81,0%.
El ensayo demostró una mejora significativa en la tasa de respuesta global en todos los niveles de expresión de PD-L1 en comparación con los controles históricos, logrando un ORR del 55,0% y una tasa de control de enfermedad del 87,5%. El perfil de seguridad sigue siendo favorable sin nuevas señales de seguridad.
Immutep (NASDAQ: IMMP)는 전이성 비편평 비소세포 폐암의 1차 치료를 위한 KEYTRUDA와 화학요법과 함께 eftilagimod alpha (efti)를 평가하는 INSIGHT-003 1상 시험에서 긍정적인 데이터를 보고했습니다. 성숙한 데이터는 중위 전체 생존 기간이 32.9개월, 중위 진행 무병 생존 기간이 12.7개월, 24개월 전체 생존율이 81.0%임을 보여줍니다.
이 시험은 역사적 대비군에 비해 모든 PD-L1 발현 수준에서 전체 반응률의 유의미한 개선을 나타내며, 55.0%의 ORR 그리고 87.5%의 질병 관리율을 달성했습니다. 안전성 프로파일은 새로운 안전 신호 없이 여전히 유리합니다.
Immutep (NASDAQ: IMMP) rapporte des données positives de l'essai clinique de phase I INSIGHT-003 qui évalue l'eftilagimod alpha (efti) en combinaison avec KEYTRUDA et une chimiothérapie pour le traitement de première ligne du cancer du poumon non à petites cellules non squameux métastatique. Les données mûres montrent une survie globale médiane de 32,9 mois, une survie sans progression médiane de 12,7 mois, et un taux de survie global à 24 mois de 81,0%.
L'essai a démontré une amélioration significative du taux de réponse global à tous les niveaux d'expression de PD-L1 par rapport aux témoins historiques, atteignant un TRR de 55,0% et un taux de contrôle de la maladie de 87,5%. Le profil de sécurité reste favorable, sans nouveaux signaux de sécurité.
Immutep (NASDAQ: IMMP) berichtet über positive Daten aus der INSIGHT-003 Phase-I-Studie, die eftilagimod alpha (efti) in Kombination mit KEYTRUDA und Chemotherapie als Erstlinientherapie bei metastasiertem nicht-squamösem nicht-kleinzelligem Lungenkrebs evaluiert. Reife Daten zeigen eine mittlere Gesamtüberlebenszeit von 32,9 Monaten, eine mittlere Freiheit von Progression von 12,7 Monaten und eine 24-Monats-Überlebensrate von 81,0%.
Die Studie zeigte eine signifikante Verbesserung der Gesamtansprechrate über alle PD-L1-Expressionsniveaus hinweg im Vergleich zu historischen Kontrollen, mit einer ORR von 55,0% und einer Krankheitskontrollrate von 87,5%. Das Sicherheitsprofil bleibt günstig und zeigt keine neuen Sicherheitszeichen.
- Median Overall Survival of 32.9 months significantly exceeds historical control of 22.0 months
- Strong 24-month Overall Survival rate of 81.0% vs historical 45.5%
- Higher Overall Response Rate across all PD-L1 expression levels (75.0% vs 62.1% in high PD-L1)
- Favorable safety profile maintained with no new safety signals
- None.
Insights
The INSIGHT-003 trial data demonstrates remarkable efficacy for efti in combination with KEYTRUDA and chemotherapy for first-line NSCLC treatment. The median Overall Survival of
Particularly noteworthy is the strong performance in PD-L1 low/negative patients, who typically respond poorly to immunotherapy. The Overall Response Rate of
This data represents a significant commercial opportunity in the lucrative first-line NSCLC market. The superior efficacy compared to current standard-of-care (pembrolizumab + chemotherapy) positions efti as a potential game-changer, especially given its strong performance in PD-L1 low/negative patients who represent approximately
The advancement toward Phase III TACTI-004 trial with these compelling results could accelerate the path to market. Given NSCLC's large market size and the clear unmet need in PD-L1 low/negative patients, successful commercialization could translate to substantial revenue potential.
Media Release
- Mature data in patients with a minimum follow-up of 22 months (N=21) shows excellent results, well above historical controls and exceeding expectations:
- Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of
81.0%
- Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of
- Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate compared to historical controls
- Safety continues to be favourable with no new safety signals
- INSIGHT-003, which is nearing completion of enrolment, evaluates efti with the most widely used immunotherapy-chemo combination today in a similar population to upcoming TACTI-004 Phase III trial
SYDNEY, AUSTRALIA, Nov. 14, 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 positive data from the investigator-initiated INSIGHT-003 Phase I trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA® (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC) patients.
Prof. Dr. Salah-Eddin Al-Batran of the Frankfurt Institute of Clinical Cancer Research (IKF) and project lead stated, “The strength of these mature survival results coupled with a favourable safety profile in first-line treatment of patients with non-squamous NSCLC, the vast majority of whom have negative or low PD-L1 expression, is very encouraging. This promising data in INSIGHT-003 suggests a complementary effect from the addition of efti, a unique MHC Class II agonist, to the standard-of-care combination of pembrolizumab and chemotherapy which has revolutionised the treatment landscape in lung cancer. The IKF will also support and is looking forward to participating in the upcoming TACTI-004 study, which has PFS and OS as dual primary endpoints.”
Key Results - Data cutoff - 15 October 2024
The survival data from the triple combination therapy in patients irrespective of PD-L1 expression with a minimum follow-up of 22 months (N=21) at data cut-off shows:
| INSIGHT-003 Results | ||
| Median Overall Survival (OS) | 32.9 months | |
| Median Progression-Free Survival (PFS) | 12.7 months | |
| 24-month Overall Survival (OS) | ||
These results compare favourably to the 22.0-month median OS, 9.0-month median PFS, and 24-month OS rate of
Marc Voigt, CEO of Immutep, stated, “The overall survival and progression-free survival data from this mature cohort of patients in INSIGHT-003 with nearly a 2-year minimum follow-up exceeds our expectations. We are encouraged to see efti build upon the historical clinical outcomes from the most widely used immunotherapy-chemo combination today. Additionally, the early evaluations in the expansion cohort of 19 patients, who all have low or negative PD-L1 expression, are tracking well and we look forward to additional data updates from the INSIGHT-003 trial in 2025 and beyond. Our focus on potentially driving a new standard of care globally in first line treatment of NSCLC is boosted by these results and we are well advanced in our preparations to initiate the TACTI-004 Phase III trial.”
Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate (ORR) according to RECIST 1.1 across all levels of PD-L1 expression compared to historical control2:
75.0% ORR versus62.1% ORR in patients with high PD-L1 expression (TPS >50% )58.8% ORR versus49.2% ORR in patients with low PD-L1 expression (TPS 1-49% )47.4% ORR versus32.3% ORR in patients with negative PD-L1 expression (TPS <1% )
In this all-comer PD-L1 trial, the
In these patients with low and negative PD-L1 expression (36 of 40 patients), the triple combination achieved a
Safety
Safety continues to be favourable for efti in combination with pembrolizumab and chemotherapy, with no new safety signals.
Next Steps
INSIGHT-003, a multi-centre study led by the Frankfurt Institute of Clinical Cancer Research IKF, is nearing completion of patient enrolment. Additional data updates from this trial are expected in 2025 and beyond.
About INSIGHT-003
INSIGHT-003 is an investigator-initiated, multi-centre study led by the Frankfurt Institute of Clinical Cancer Research (IKF). 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 doublet chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.
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
1, 2. 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.
FAQ
What are the key survival results from Immutep's INSIGHT-003 trial for NSCLC?
What is the Overall Response Rate (ORR) in IMMP's INSIGHT-003 trial?
How does IMMP's efti combination therapy compare to historical controls in NSCLC?
