Posted: 15 January 2025
Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer andautoimmune disease, today announces that patient enrolment has been completed in the investigatorinitiated INSIGHT-003 trial. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the antiPD-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 81.0%1. These results compare favourably to the 22.0-month median OS and 24-month OS rate of 45.5% from a registrational trial of anti-PD-1 and doublet chemotherapy in nonsquamous 1L NSCLC regardless of PD-L1 expression.
Additional data updates from INSIGHT-003 are expected in 2025 and beyond. For more information on the trial, please visit clinicaltrials.gov (NCT03252938).
