Local biotech kicks off phase 3 trial for lung cancer combination therapy

ASX-listed biotech company Immutep has reached a major milestone, announcing that the first patient has been successfully dosed in its TACTI-004 phase III trial. The late-stage immunotherapy company is developing innovative treatments for cancer and autoimmune diseases.

TACTI-004 is set to evaluate eftilagimod alfa (efti), Immutep’s first-in-class MHC Class II agonist, in combination with MSD’s Keytruda (pembrolizumab) and chemotherapy. The trial targets advanced or metastatic non-small cell lung cancer (NSCLC), the most prevalent form of lung cancer, accounting for 80-85% of all diagnoses. With many cases detected at an advanced stage, the five-year survival rate remains below 30%.

Medical oncologist, Dr Ina Nordman, who treated the first patient at Calvary Mater Newcastle Hospital, stated “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.”

“Dosing the first patient in our pivotal Phase III trial ranks among the most significant milestones in the company’s history. If successful, the study will result in a clinically meaningful and statistically improved survival benefit and thus could potentially be practice changing,” said Immutep CEO Marc Voigt.

Immutep’s Chief Scientific Officer, Dr Frédéric Triebel, commented “Importantly, this novel approach has an excellent safety profile while delivering strong efficacy that compares favourably to standard-of-care therapies, including high rates of durable responses and compelling progression-free survival and overall survival.”

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