Immutep Limited has announced the completion of patient enrollment in the INSIGHT-003 trial, a Phase I study evaluating eftilagimod alpha (efti) in combination with pembrolizumab (Keytruda) and doublet chemotherapy for first-line treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The multi-center trial, conducted across several sites in Germany under the leadership of the Frankfurt Institute of Clinical Cancer Research IKF, has reached its target of approximately 50 evaluable patients.
The INSIGHT-003 trial is an investigator-initiated study and represents the third arm (Stratum C) of the ongoing Phase I INSIGHT trial. It assesses the safety, tolerability, and initial efficacy of a triple combination therapy. This combination includes subcutaneous administration of efti alongside the standard-of-care combination of intravenous pembrolizumab (an anti-PD-1 therapy) and chemotherapy (carboplatin and pemetrexed).
Promising Early Overall Survival Data
Initial overall survival (OS) results from INSIGHT-003, reported on November 14, 2024, demonstrated a median 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 findings compare favorably to a registrational trial of anti-PD-1 therapy and doublet chemotherapy in non-squamous NSCLC, which reported a median OS of 22.0 months and a 24-month OS rate of 45.5%, regardless of PD-L1 expression.
INSIGHT-003 Trial Design
The INSIGHT-003 trial (NCT03252938) is designed to evaluate the feasibility rate of the treatment as the primary endpoint. Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), incidence and severity of adverse events, and immune response in whole blood and tumor tissue. The study enrolled patients aged 18 years or older with histologically confirmed locally advanced or metastatic solid tumors, an ECOG performance status of 0 or 1, adequate organ function, and a life expectancy of 3 months or more.
Future Expectations
Immutep anticipates further data updates from INSIGHT-003 in 2025 and beyond. These updates are expected to provide additional insights into the potential of efti in combination with pembrolizumab and chemotherapy to improve outcomes for patients with advanced NSCLC.
