Immutep (ASX:IMM) has announced that the first patient has been successfully dosed in its pivotal TACTI-004 Phase 3 trial.
The trial will evaluate Immutep’s eftilagimod alfa, a first-in-class MHC Class II agonist, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC).
Dr Ina Nordman, who treated the first patient at Calvary Mater Newcastle Hospital in Australia, said, “We are very excited to participate in this important Phase III trial. Despite advancements in the treatment landscape for non-small cell lung cancer, there remains a high unmet need for new approaches that can safely extend patients’ lives. The anti-cancer immune response driven by efti’s unique mechanism of action as an MHC Class II agonist in combination with KEYTRUDA has led to strong efficacy across all PD-L1 levels with favourable safety in multiple lung cancer trials. We hope to see this study confirm the promise of this novel combination to provide patients with a powerful new treatment option.”
Immutep CEO Marc Voigt added, “Dosing the first patient in our pivotal Phase III trial ranks among the most significant milestones in the Company’s history. We are excited about the potential of the TACTI-004 study to deliver a new standard-of-care therapy for patients with metastatic or advanced non-small cell lung cancer that includes efti in combination with KEYTRUDA. If successful, the study will result in a clinically meaningful and statistically improved survival benefit and thus could potentially be practice-changing.”