On July 3, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported details for an upcoming oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary session on July 11, 2024, featuring new clinical data in patients with negative PD-L1 expression (Cohort B) in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, and a webcast to discuss these clinical results (Press release, Immutep, JUL 3, 2024, View Source [SID1234644662]).
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ESMO Virtual Plenaries are monthly presentations of the latest, original scientific data, including "Phase II trials which demonstrate remarkable therapeutic benefit, scientific insight or progress in an area of unmet need". The oral presentation will announce the substantially improved overall response rate, as advised 27 June 2024, and additional data in patients with first line head and neck squamous cell carcinoma who have negative PD-L1 (Cohort B).
Details for the ESMO (Free ESMO Whitepaper) Plenary presentation
Title: Eftilagimod Alpha (Soluble LAG-3) & Pembrolizumab in First-Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma: Primary Results from Cohort B (CPS <1) of the TACTI-003 Study
Presenter: Dr. Robert Metcalf, The Christie NHS Foundation Trust, Manchester, U.K.
Format: Oral Presentation
Date/Time: 18:30-19:30 Central European Time (CEST), July 11, 2024
Webcast Details
Immutep will host a webcast to discuss the clinical data. A replay of the webcast will be available under the Events section of Immutep’s website after the event.
Date/Time: Friday, July 12, at 9am AEST (7pm ET July 11)
Register: Link to register for webcast
Questions: Investors are invited to submit questions in advance via [email protected]
About the TACTI-003 Trial
The TACTI-003 (KEYNOTE-PNC-34) trial is an ongoing Phase IIb study evaluating eftilagimod alfa (efti), Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with pembrolizumab as compared to pembrolizumab monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with pembrolizumab in patients with PD-L1 negative tumours.
The primary endpoint of the study is Overall Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival, Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027).
About Eftilagimod Alfa (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-g and CXCL10 that further boost the immune system’s ability to fight cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).