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Immutep - Positive topline results from ph2b in head & neck cancer

  • Efti in combination with KEYTRUDA® (pembrolizumab) in first line head and neck squamous cell carcinoma (1L HNSCC) led to overall response rates that exceed KEYTRUDA monotherapy across all levels of PD-L1 expression
  • In the randomised, controlled Cohort A, the combination shows the strongest performance in patients with high PD-L1 expression (CPS >20) with an overall response rate (ORR) of 31.0% as compared to 18.5% for KEYTRUDA monotherapy
  • In patients with negative PD-L1 expression (CPS <1, Cohort B), a patient population with no effective chemotherapy-free options, the response rate has substantially improved from the preliminary 26.9% ORR reported in April and topline results with additional data has been accepted for oral presentation at an ESMO Virtual Plenary session on 11th July
  • Additional clinical data from TACTI-003 will be presented at a medical conference in H2 CY2024
  • Based on the positive topline results, the Company will discuss the path forward in 1L HNSCC with regulatory agencies
  • Immutep to host webcast to discuss clinical data today at 9AM AEST (7PM ET, Wednesday 26 June)

SYDNEY, AUSTRALIA – June 27, 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, today announces topline results from the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC). The trial enrolled 171 patients with any PD-L1 expression (Combined Positive Score [CPS] ≥1) and negative PD-L1 expression (CPS <1) at over 30 centres across the United States, Europe, and Australia.

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