Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced positive developments across its clinical programs, including positive FDA feedback for its planned Phase III trial of eftilagimod alfa (efti) in first-line non-small cell lung cancer (NSCLC) and promising Phase IIb results in head and neck cancer. The company also dosed the first participant in a Phase I trial of IMP761, a novel LAG-3 agonist antibody for autoimmune diseases.
Efti Development Program for Cancer
TACTI-004 (KEYNOTE-PNC91) – 1L NSCLC Phase III Clinical Collaboration with MSD
Immutep received positive feedback from the US Food and Drug Administration (FDA) regarding its planned TACTI-004 Phase III trial of 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. This regulatory milestone follows positive guidance from the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products. The study will enroll approximately 750 patients, addressing the entire 1L NSCLC market eligible for anti-PD-1 therapy.
TACTI-003 (KEYNOTE-C34) – Phase IIb Clinical Trial in 1L HNSCC
The TACTI-003 trial is evaluating efti in combination with KEYTRUDA® as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC). Updated results from Cohort B, presented at an ESMO Virtual Plenary session, showed a 35.5% objective response rate (ORR) in patients with PD-L1 negative tumors (CPS <1). This ORR is among the highest recorded for a treatment approach not containing chemotherapy in this patient population. The combination also achieved a 9.7% complete response rate, compared favorably to historical controls of 0% with anti-PD-1 monotherapy. Data from Cohort A, presented at the ESMO Congress 2024, indicated that in patients with PD-L1 positive tumors (CPS ≥1), efti in combination with KEYTRUDA® outperformed KEYTRUDA® monotherapy, particularly in those with CPS ≥20 (31.0% ORR vs. 18.5% ORR). The combination also demonstrated a high durability of response (17.5 months) and a favorable safety profile. A statistically significant increase in absolute lymphocyte count was observed in the efti with KEYTRUDA® arm, suggesting an effective efti-induced immune response.
AIPAC-003 – Integrated Phase II/III Trial in MBC
Patient enrollment in the randomized Phase II portion of the AIPAC-003 trial was completed in October. This phase enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who had progressed after endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients were randomized 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose of efti.
IMP761 Development Program for Autoimmune Disease
Immutep has dosed the first participant in the first-in-human Phase I trial of IMP761, a first-in-class agonist LAG-3 antibody designed to restore balance to the immune system by enhancing the "brake" function of LAG-3. Safety data from this study is expected by the end of 2024, with pharmacokinetics and pharmacodynamics data in the first half of 2025.
Corporate and Financial Update
Immutep was added to the S&P/ASX 300 index, recognizing the company's growth and enhancing its market visibility. The company reported a strong cash position of A$172.3 million as of September 30, 2024, providing an expected cash reach to the end of CY2026.
