Immutep Announces Independent Data Monitoring Committee

Media Release

SYDNEY, AUSTRALIA, Oct. 26, 2022 (GLOBE NEWSWIRE) — Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the Independent Data Monitoring Committee (IDMC) for the randomised, controlled Phase IIb TACTI-003 trial has reviewed initial safety data and recommended continuing the trial with no modifications.

TACTI-003 is evaluating eftilagimod alpha (“efti” or “IMP321”), in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as a 1st line therapy in approximately 154 patients with head and neck squamous cell carcinoma (HNSCC).

The IDMC safety analysis included 47 patients enrolled in either cohort A or cohort B of the TACTI-003 trial. Subjects in cohort A (CPS ≥1) are randomized 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone. Subjects in cohort B (CPS <1) receive a combination of efti and pembrolizumab. The IDMC also reviewed initial efficacy data, although this was not the primary focus of the analysis.

Immutep’s CSO and CMO Dr. Frédéric Triebel said, “We are very pleased with the IDMC’s recommendation. While early, this represents positive affirmation of the decision to move TACTI-003 into the 1st line setting for head and neck squamous cell carcinoma patients following the robust results and durable responses that efti in combination with pembrolizumab achieved in the 2nd line setting. Notably, the encouraging antitumour activity previously attained spanned the entire spectrum of PD-L1 expression, which is important as the majority of patients have lower PD-L1 levels and are in need of new approaches to fight cancer.”

Currently, 53/154 patients (approximately 34%) have been recruited into the TACTI-003 trial, and recruitment is accelerating as further sites have been activated in…