Immutep Reaches Enrolment Target for INSIGHT-003 Trial in 1st Line NSCLC

Posted: 7 February 2023

Immutep Limited, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, today announces the investigator-initiated INSIGHT-003 trial has reached its enrolment target of 20 patients with 1L NSCLC. INSIGHT-003 is the first trial evaluating 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.

Immutep’s CSO & CMO Dr Frederic Triebel said, “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.”

In a poster presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022, initial results in 1L NSCLC patients show the triple combination therapy is well-tolerated and provides promising early signals of therapeutic activity with an Objective Response Rate (ORR) of 72.7% (8/11) and a Disease Control (DCR) of 90.9% (10/11). Nine patients had a PD-L1 Tumour Proportion Score (TPS) of <50% and this group reported an encouraging ORR of 66.7% and DCR of 88.9%. Patients with a PD-L1 of <50% represent approximately two-thirds of the 1L NSCLC patient population and are less responsive to anti-PD-1 therapy compared to patients with a PD-L1 TPS of ≥50%.

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