-- Final discussion with the FDA, successfully concluding the regulatory preparations for the TACTI-004 Phase III trial design to evaluate efti in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, and standard chemotherapy in first-line non-small cell lung cancer
-- TACTI-004 registrational trial will enrol ~750 patients regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapy
SYDNEY, AUSTRALIA – 22 July 2024 – 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 positive feedback has been received from the US Food and Drug Administration (“FDA”) regarding the planned TACTI-004 Phase III trial of eftilagimod alfa (“efti”) in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.
The FDA feedback from this Type C meeting, along with feedback previously received from the Paul-Ehrlich-Institut (“PEI”) and the Spanish Agency for Medicines and Health Products (“AEMPS”), concludes the preparatory regulatory interactions for the design of this registrational trial. This marks a significant step forward to develop an effective treatment for non-squamous and squamous 1L NSCLC patients who have high, low, or no PD-L1 expression and are eligible for anti-PD-1 therapy.
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