Immutep Reports Positive FDA Feedback and Clinical Advancements in Q1 FY25
核心洞察
Immutep received positive FDA feedback for its TACTI-004 Phase III trial in first-line non-small cell lung cancer (搜索), marking a crucial step in regulatory preparations.
The TACTI-003 Phase IIb trial demonstrated a 35.5% objective response rate in PD-L1 negative head and neck cancer (搜索) patients treated with efti and KEYTRUDA.
Immutep initiated a Phase I trial of IMP761 for autoimmune diseases (搜索), with the first participant successfully dosed, signaling progress in novel LAG-3 (搜索) therapies.
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced significant progress in its Q1 FY25, highlighted by positive FDA feedback for its TACTI-004 Phase III trial in first-line non-small cell lung cancer (搜索) (1L NSCLC) and promising results from the TACTI-003 Phase IIb trial in head and neck cancer (搜索). The company also dosed the first participant in a Phase I trial of IMP761 for autoimmune diseases (搜索). These advancements underscore Immutep's commitment to developing novel LAG-3 (搜索) immunotherapies.
TACTI-004: Advancing NSCLC Treatment
The FDA's positive feedback on the TACTI-004 trial design, which combines eftilagimod alfa (efti) with KEYTRUDA® (pembrolizumab) and platinum doublet chemotherapy, marks a crucial step forward. This Phase III trial aims to enroll approximately 750 patients with 1L NSCLC, irrespective of PD-L1 expression. The trial design has been refined based on guidance from regulatory bodies including the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products.
TACTI-003: Promising Results in Head and Neck Cancer
Updated results from Cohort B of the TACTI-003 Phase IIb trial, presented at an ESMO Virtual Plenary session, revealed a 35.5% objective response rate (ORR) in patients with PD-L1 negative recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC) treated with efti in combination with KEYTRUDA®. Notably, the combination therapy achieved a 9.7% complete response rate, which compares favorably to the 0% historical control rate observed with anti-PD-1 monotherapy in similar patients. Data from Cohort A showed that in patients with PD-L1 positive tumours (CPS ≥1), efti in combination with KEYTRUDA outperformance was largest in CPS ≥20 with 31.0% ORR versus 18.5% ORR for KEYTRUDA monotherapy. The median duration of response was 17.5 months in patients with CPS ≥1. A statistically significant increase in absolute lymphocyte count was observed in the efti with KEYTRUDA arm, indicating an effective efti-induced immune response.
IMP761: A Novel Approach to Autoimmune Disease
Immutep has initiated a Phase I trial of IMP761, a first-in-class agonist LAG-3 (搜索) antibody, designed to treat autoimmune diseases (搜索). The first participant was successfully dosed after receiving regulatory clearance in the Netherlands. IMP761 aims to restore immune balance by enhancing the “brake” function of LAG-3, silencing dysregulated self-antigen-specific memory T cells. Safety data from this study is expected by the end of 2024, with pharmacokinetics and pharmacodynamics data anticipated in the first half of CY2025.
Financial Stability and Market Growth
As of September 30, 2024, Immutep reported a strong cash position of A$172.3 million, comprising A$120.3 million in cash and an A$52.0 million bank term deposit. This financial stability is projected to sustain the company through the end of CY2026. Immutep was also added to the S&P ASX300 Index, recognizing its growth and enhancing its market visibility.
Immutep's Q1 FY25 activities reflect significant progress in its clinical programs and financial health, positioning the company for continued growth and innovation in the fields of cancer and autoimmune disease immunotherapy.