• Pivotal TACTI-004 (KEYNOTE-F91) Phase III trial for efti in first line non-small cell lung cancer continues to build momentum
• Positive feedback from FDA on future late-stage clinical development of efti in first line head and neck cancer patients with PD-L1 expression below 1 (CPS <1)
• New investigator-initiated Phase II trial evaluating neoadjuvant efti in early-stage HR+/HER2-negative breast cancer patients

Immutep Limited, a late-stage immunotherapy company, provides an update on its activities for the quarter ended 30 September 2025 (Q1 FY26). The company's pivotal TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's anti-PD-1 therapy KEYTRUDA and chemotherapy as first-line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC) continues to build momentum, with over 100 clinical sites open for enrollment and 24 countries that have received regulatory approval. The trial has enrolled and randomised over 170 patients, reaching an important milestone. Immutep also received positive and constructive feedback from the FDA regarding future late-stage clinical development of efti in first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1). Additionally, the company announced the launch of an investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients. Immutep is well-funded with a strong cash, cash equivalent, and term deposit balance of approximately A$109.85 million as of 30 September 2025, providing an expected cash reach to the end of CY2026.

Immutep is well-funded with a strong cash, cash equivalent, and term deposit balance of approximately A$109.85 million as of 30 September 2025, providing an expected cash reach to the end of CY2026.