Immutep Limited (ASX: IMM) received positive feedback from the Paul-Ehrlich-Institut (PEI) regarding its TACTI-004 Phase III trial. PEI, a German regulatory authority affiliated with the Committee for Medicinal Products for Human Use (CHMP), expressed support for the trial, marking a significant step in advancing potential treatments for first-line NSCLC using eftilagimod alpha (efti). PEI supports Immutep's transition into a registrational trial for first-line NSCLC, exploring efti in combination with anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination with chemotherapy.
Acknowledging efti's favourable safety profile with anti-PD-1 therapy, PEI discussed trial design elements, including control arm selection and defining the patient population based on PD-L1 expression. Ongoing interactions with the U.S. FDA, European regulators, and potential partners are in progress, with Immutep planning to unveil the final TACTI-004 trial design in Q1 of CY2024.
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Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
