- Immutep (ASX:IMM) welcomes constructive feedback from German regulatory authority for its planned TACTI-004 phase three trial of efti for first-line treatment of metastatic NSCLC
- The PEI voiced its support for the movement of the study into a registrational trial
- The authority acknowledged the good safety profile of efti in combination with anti-PD-1 therapy
- The final trial design for TACTI-004 is anticipated for Q1 CY24
- IMM shares last traded at 35.5 cents
Immutep (ASX:IMM) has welcomed constructive feedback from German regulatory authority, Paul-Ehrlichlnstitut (PEI), for its planned TACTI-004 phase three trial of efti for first-line treatment of metastatic non-small cell lung cancer (NSCLC).
The PEI voiced its support for the movement of the study into a registrational trial, evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy.
The authority acknowledged the good safety profile of efti in combination with anti-PD-1 therapy and other discussions including the design of the trial were discussed.
“We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months,” Immutep CEO Marc Voigt said.
“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.”
Immutep is facilitating interactions with the US Food and Drug Administration (FDA), local European regulators and other stakeholders.
The final trial design for TACTI-004 is anticipated for the first quarter of the 2024 calendar year.
IMM shares last traded at 35.5 cents.