Posted: 22 December 2023
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 constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (NSCLC).
The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. Also, the PEI acknowledged the good safety profile of efti in combination with anti-PD-1 therapy.
Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and the potential patient population as defined by level of PD-L1 expression. Additional interactions with the U.S. Food and Drug Administration (FDA), other local European regulators, as well as with other stakeholders and potential partners are ongoing. Immutep plans to announce its final trial design for TACTI-004 in Q1 of CY2024.
Immutep CEO, Marc Voigt, commented: “We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months. Immutep is uniquely positioned to address multiple patient populations within non-small cell lung cancer as defined by their level of PD-L1 expression, including high, low, and negative expressors, with either efti combined with anti-PD-1 therapy or a triple combination approach including chemotherapy. Our confidence in efti’s ability in this important indication stems from the mature data in the large TACTI-002 Phase II trial, and the emerging data from the triple combination INSIGHT-003 study.”
