Immutep's INSIGHT-003 Trial Reaches Enrollment Target in First-Line NSCLC

Key Insights

• The INSIGHT-003 trial, evaluating eftilagimod alpha in combination with anti-PD-1 therapy and chemotherapy, has reached its enrollment target of 20 patients with 1L NSCLC.
• Initial results from the triple combination therapy showed a 72.7% objective response rate and a 90.9% disease control rate in 1L NSCLC patients.
• The study is evaluating the safety, tolerability, and initial efficacy of the triple combination in patients with previously untreated non-small cell lung cancer.

Immutep Limited has announced that its investigator-initiated INSIGHT-003 trial has reached its enrollment target of 20 patients with first-line non-small cell lung cancer (1L NSCLC). The INSIGHT-003 trial is the first to evaluate Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), as part of a triple combination therapy with standard-of-care anti-PD-1 therapy and chemotherapy.

The trial, conducted at the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt, is evaluating the safety, tolerability, and initial efficacy of efti administered subcutaneously in conjunction with pembrolizumab (anti-PD-1 therapy) and chemotherapy (carboplatin and pemetrexed) delivered intravenously.

Promising Initial Efficacy

Initial results presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022 demonstrated promising early signals of therapeutic activity. The triple combination therapy was well-tolerated, with an Objective Response Rate (ORR) of 72.7% (8/11) and a Disease Control Rate (DCR) of 90.9% (10/11). Notably, in the subgroup of patients with a PD-L1 Tumor Proportion Score (TPS) of <50%, the ORR was 66.7% and the DCR was 88.9%. This is particularly encouraging, as patients with lower PD-L1 expression are typically less responsive to anti-PD-1 therapy.

Efti's Potential in NSCLC

Dr. Frederic Triebel, CSO & CMO of Immutep, stated, "The promising initial efficacy and favourable safety results reported in November 2022 from this first triple combination approach instils more confidence in the flexibility of our novel immunotherapy, efti, to be combined with various therapeutics and safely drive superior patient outcomes. We are pleased to have reached our enrolment target and look forward to reporting as the results mature further. Additional data from INSIGHT-003 will help further inform our next steps in 1st line NSCLC."

Study Design

INSIGHT-003 is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial, with Prof. Dr. Salah-Eddin Al-Batran as the lead investigator. The trial aims to assess the feasibility of combining eftilagimod alpha with standard-of-care therapy in advanced NSCLC.