Immutep Limited (ASX: IMM; NASDAQ: IMMP) has expanded the INSIGHT-003 trial to include four sites across Germany, including the University Clinic of Ruhr Universität Bochum and the Lung Clinic Cologne-Merheim. This expansion aims to accelerate enrollment in the investigator-initiated study evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy KEYTRUDA® and doublet chemotherapy for the initial treatment of non-squamous non-small cell lung cancer (NSCLC).

The early clinical data from the first-in-man triple combination study demonstrated promising results, leading to an increase in the number of participants to 50. The trial, initiated in mid-2023, has enrolled 29 patients so far. With the inclusion of the new sites, recruitment is anticipated to conclude in the first half of the calendar year 2024.

As presented at the ESMO Congress 2023, the triple combination in INSIGHT-003 exhibited a noteworthy 70.6% overall response rate and a median progression-free survival of 10.9 months in patients with a PD-L1 Tumor Proportion Score (TPS) of <50%, a group typically less responsive to anti-PD-1 therapy. These outcomes compare favorably to data from a registrational trial of anti-PD-1 and doublet chemotherapy in the same patient population, which reported a response rate of 40.8%.

Additionally, the triple combination has demonstrated good tolerability, and the inclusion of efti does not seem to increase the toxicity of KEYTRUDA® and carboplatin/pemetrexed. This further builds upon the favorable safety profile of efti established in various clinical trials to date.

INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF, operating as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial. Lead investigator Prof. Dr. Salah-Eddin Al-Batran is evaluating the triple combination therapy in front-line non-small cell lung cancer patients. The therapy consists of subcutaneously administered efti in conjunction with the approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and intravenously delivered doublet chemotherapy (carboplatin and pemetrexed). The trial's primary objectives include assessing the safety, tolerability, and initial efficacy of this combination.

 

Source: immutep.com

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