BRIEF—Immutep cleared to continue TACTI-003 trial

Australian clinical-stage biotech Immutep today announced that the Independent Data Monitoring Committee (IDMC) for the randomized, 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 Merck & Co anti-PD-1 therapy Keytruda (pembrolizumab) as a first 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 greater than or equal to 1) are randomized 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone.

Subjects in cohort B (CPS less than 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.