Patient Enrolment Completed for INSIGHT-003
Immutep (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company, announced the completion of patient enrolment for the INSIGHT-003 trial. This multi-centre Phase I trial evaluates the combination of eftilagimod alpha (efti), pembrolizumab (KEYTRUDA®), and doublet chemotherapy as a first-line treatment for advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).
The trial has enrolled approximately 50 evaluable patients across multiple sites in Germany, led by the Frankfurt Institute of Clinical Cancer Research IKF. Initial results, reported on 14 November 2024, showed a median Overall Survival (OS) of 32.9 months and a 24-month OS rate of 81.0% in patients with a minimum follow-up of 22 months (N=21). These results compare favourably to a registrational trial showing a median OS of 22.0 months and a 24-month OS rate of 45.5% for anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression.
Further data updates from the INSIGHT-003 trial are expected in 2025 and beyond. For more information on the trial, visit clinicaltrials.gov (NCT03252938).
Immutep (ASX: IMM; NASDAQ: IMMP), una compagnia biotecnologica in fase clinica, ha annunciato il completamento dell'arruolamento dei pazienti per il trial INSIGHT-003. Questo trial di fase I multicentrico valuta la combinazione di eftilagimod alfa (efti), pembrolizumab (KEYTRUDA®) e chemioterapia in doppio trattamento come terapia di prima linea per il cancro polmonare non a piccole cellule non squamoso avanzato o metastatico (1L NSCLC).
Il trial ha arruolato circa 50 pazienti valutabili in diversi centri in Germania, guidato dall'Istituto di Ricerca Clinica sul Cancro di Francoforte IKF. I risultati iniziali, riportati il 14 novembre 2024, hanno mostrato una sopravvivenza complessiva mediana (OS) di 32,9 mesi e un tasso di sopravvivenza a 24 mesi dell'81,0% in pazienti con un follow-up minimo di 22 mesi (N=21). Questi risultati sono favorevoli rispetto a uno studio registrativo che mostrava una sopravvivenza mediana di 22,0 mesi e un tasso di OS a 24 mesi del 45,5% per il trattamento anti-PD-1 e la chemioterapia in doppio nel NSCLC non squamoso 1L, indipendentemente dall'espressione di PD-L1.
Ulteriori aggiornamenti sui dati del trial INSIGHT-003 sono previsti per il 2025 e oltre. Per ulteriori informazioni sul trial, visita clinicaltrials.gov (NCT03252938).
Immutep (ASX: IMM; NASDAQ: IMMP), una empresa de biotecnología en etapa clínica, anunció la finalización del reclutamiento de pacientes para el ensayo INSIGHT-003. Este ensayo de fase I, multicéntrico, evalúa la combinación de eftilagimod alfa (efti), pembrolizumab (KEYTRUDA®) y quimioterapia en doble tratamiento como terapia de primera línea para el cáncer de pulmón de células no pequeñas no squamosas avanzado o metastásico (1L NSCLC).
El ensayo ha reclutado aproximadamente 50 pacientes evaluables en varios sitios en Alemania, liderado por el Instituto de Investigación Clínica del Cáncer de Francfort IKF. Los resultados iniciales, reportados el 14 de noviembre de 2024, mostraron una supervivencia general media (OS) de 32,9 meses y una tasa de OS a 24 meses del 81,0% en pacientes con un seguimiento mínimo de 22 meses (N=21). Estos resultados son favorables en comparación con un ensayo registral que mostró una OS media de 22,0 meses y una tasa de OS a 24 meses del 45,5% para el tratamiento anti-PD-1 y quimioterapia en doble en NSCLC no squamoso 1L, independientemente de la expresión de PD-L1.
Se esperan más actualizaciones de datos del ensayo INSIGHT-003 en 2025 y más allá. Para más información sobre el ensayo, visita clinicaltrials.gov (NCT03252938).
Immutep (ASX: IMM; NASDAQ: IMMP), 임상 단계의 생명공학 회사가 INSIGHT-003 임상 시험의 환자 등록 마감을 발표했습니다. 이 다기관 1상 시험은 비편평 비소세포 폐암(1L NSCLC)에 대한 1차 치료로, eftilagimod alpha(efti), pembrolizumab(KEYTRUDA®), 및 이중 화학요법의 조합을 평가합니다.
이 시험은 독일의 여러 기관에서 약 50명의 평가 가능한 환자를 등록했으며, 프랑크푸르트 임상 암 연구소 IKF가 이끌고 있습니다. 초기 결과는 2024년 11월 14일에 보고되었으며, 최소 22개월의 추적 관찰을 가진 환자(N=21)에서 중앙 전체 생존 기간(OS)이 32.9개월, 24개월 OS 비율이 81.0%로 나타났습니다. 이 결과는 PD-L1 발현과 관계없이 비편평 1L NSCLC에서 항 PD-1 및 이중 화학요법의 등록 시험에서 22.0개월의 중앙 OS 및 24개월 OS 비율이 45.5%인 결과와 비교했을 때 긍정적입니다.
INSIGHT-003 임상 시험에 대한 추가 데이터 업데이트는 2025년 및 그 이후에 제공될 예정입니다. 임상 시험에 대한 자세한 내용은 clinicaltrials.gov (NCT03252938)를 방문하세요.
Immutep (ASX: IMM; NASDAQ: IMMP), une entreprise biopharmaceutique en phase clinique, a annoncé l'achèvement du recrutement des patients pour l'essai INSIGHT-003. Cet essai de phase I multicentrique évalue la combinaison d’eftilagimod alpha (efti), de pembrolizumab (KEYTRUDA®) et de chimiothérapie en doublet comme traitement de première intention pour le cancer du poumon non à petites cellules non squameux avancé ou métastatique (1L NSCLC).
L'essai a inclus environ 50 patients évaluables sur plusieurs sites en Allemagne, dirigé par l'Institut de Recherche Clinique sur le Cancer de Francfort IKF. Les résultats initiaux, rapportés le 14 novembre 2024, ont montré une durée médiane de survie globale (OS) de 32,9 mois et un taux de survie à 24 mois de 81,0 % chez les patients avec un suivi minimum de 22 mois (N=21). Ces résultats sont favorables par rapport à un essai d'enregistrement montrant une OS médiane de 22,0 mois et un taux de survie à 24 mois de 45,5 % pour un traitement anti-PD-1 et de la chimiothérapie en double dans le NSCLC non squameux 1L, indépendamment de l'expression de PD-L1.
De nouvelles mises à jour des données de l'essai INSIGHT-003 sont attendues en 2025 et au-delà. Pour plus d'informations sur l'essai, visitez clinicaltrials.gov (NCT03252938).
Immutep (ASX: IMM; NASDAQ: IMMP), ein biotechnologisches Unternehmen in der klinischen Phase, gab den Abschluss der Patientenrekrutierung für die INSIGHT-003 Studie bekannt. Diese multizentrische Phase-I-Studie bewertet die Kombination aus eftilagimod alfa (efti), pembrolizumab (KEYTRUDA®) und Doppelchemotherapie als Erstlinienbehandlung für fortgeschrittenen oder metastasierenden nicht-squamous nicht-kleinzelligen Lungenkrebs (1L NSCLC).
In der Studie wurden etwa 50 evaluierbare Patienten an mehreren Standorten in Deutschland rekrutiert, geleitet vom Frankfurter Institut für klinische Krebsforschung IKF. Erste Ergebnisse, die am 14. November 2024 veröffentlicht wurden, zeigten eine mediane Gesamtüberlebenszeit (OS) von 32,9 Monaten und eine 24-Monats-OS-Rate von 81,0% bei Patienten mit einer Mindestnachbeobachtungszeit von 22 Monaten (N=21). Diese Ergebnisse sind vorteilhaft im Vergleich zu einer registrierungsrelevanten Studie, die eine mediane OS von 22,0 Monaten und eine 24-Monats-OS-Rate von 45,5% für Anti-PD-1 und Doppelchemotherapie bei nicht-squamous 1L NSCLC unabhängig von der PD-L1-Expression zeigt.
Weitere Datenaktualisierungen aus der INSIGHT-003-Studie werden für 2025 und darüber hinaus erwartet. Für weitere Informationen zu der Studie besuchen Sie clinicaltrials.gov (NCT03252938).
- Completion of patient enrolment for INSIGHT-003 trial.
- Initial median OS of 32.9 months and 24-month OS rate of 81.0%, outperforming a comparable trial.
- Approximately 50 evaluable patients enrolled across multiple sites in Germany.
- None.
Insights
- Multi-centre trial evaluating efti in combination with pembrolizumab and chemotherapy in patients with non-small cell lung cancer reaches enrolment target of approximately 50 evaluable patients
- Data updates from INSIGHT-003 are expected in 2025 and beyond
SYDNEY, AUSTRALIA, Jan. 06, 2025 (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 patient enrolment has been completed in the investigator-initiated INSIGHT-003 trial. 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).
The Phase I trial has reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF.
First Overall Survival results from INSIGHT-003 were reported on 14 November 2024, showing mature data in patients with a minimum follow-up of 22 months (N=21) achieved a median Overall Survival of 32.9 months and a 24-month Overall Survival rate of
Additional data updates from INSIGHT-003 are expected in 2025 and beyond. For more information on the trial, please visit clinicaltrials.gov (NCT03252938).
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 first 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 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.
1. Data cutoff - 15 October 2024
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.
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
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