Immutep's FDA meeting outcome

Immutep Limited (ASX: $IMM) has received positive feedback 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) 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 TACTI-004 registrational trial will enroll approximately 750 patients to address the entire 1L NSCLC market eligible for anti-PD-1 therapy.

Executive Commentary

We are pleased with the FDA's feedback as this allows us to successfully conclude our regulatory preparation for the TACTI-004 registrational trial. This represents a key milestone in our late-stage development process for efti centred on potentially driving a new standard of care globally in the treatment of non-small cell lung cancer. We hope to achieve this through efti in combination with KEYTRUDA, which has led to strong efficacy data with a favourable safety profile in 1L NSCLC patients regardless of PD-L1 expression.

Summary of FDA meeting outcome

Immutep's successful meeting with the FDA regarding the TACTI-004 Phase III trial design marks a significant step forward in the company's late-stage development process for eftilagimod alfa (efti). The registrational trial, enrolling approximately 750 patients, aims to address the entire 1L NSCLC market eligible for anti-PD-1 therapy. The positive feedback received from the FDA, along with previous feedback from other regulatory bodies, signifies progress towards developing an effective treatment for non-squamous and squamous 1L NSCLC patients, regardless of PD-L1 expression. Immutep aims to potentially drive a new standard of care globally in the treatment of non-small cell lung cancer through efti in combination with KEYTRUDA, leveraging strong efficacy data and a favourable safety profile in 1L NSCLC patients. The company's dedication to leveraging its expertise in LAG-3 immunotherapy reflects its commitment to bringing innovative treatment options to patients and maximizing value for shareholders.