Exhibit 99.1
ASX/Media Release
Immutep Achieves 50% Enrollment Milestone in Randomised Phase IIb TACTI-003 Trial for First Line Head & Neck Cancer
SYDNEY, AUSTRALIA – 4 January 2023 – 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 that it has enrolled and randomised over 50% of the planned 154 patients in the TACTI-003 Phase IIb trial. TACTI-003 is evaluating Immutep’s first-in-class soluble LAG-3 protein eftilagimod alpha (“efti”), in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as 1st line treatment of recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC).
Marc Voigt, CEO of Immutep stated: “We are pleased to reach this important milestone and extend our sincere appreciation to our investigators, clinical team, partners, and most importantly patients, that have participated in this study. As clinical evidence showing the compelling benefits of combining efti with immune checkpoint therapies such as pembrolizumab continues to grow, we are increasingly excited about efti’s potential to safely deliver superior clinical outcomes and meaningfully expand the population of cancer patients that respond to treatment.”
The 1:1 randomised, controlled multinational TACTI-003 trial is currently accruing patients at over 25 centers in the United States, Australia, and Europe, and is expected to be fully recruited by mid-2023. Based largely on the promising data in 2nd line HNSCC from the Phase II TACTI-002 trial (KEYNOTE-798), including encouraging overall response rates regardless of PD-L1 expression and five complete responses (CR), eftilagimod alpha was granted Fast Track designation by the FDA in April 2021 for treatment of 1L HNSCC.
As recently announced, the Independent Data Monitoring Committee (IDMC) for the TACTI-003 trial reviewed initial safety data and recommended continuing the trial with no modifications. The IDMC also reviewed initial efficacy data, although this was not the primary focus of the analysis.
HNSCC is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000 deaths reported in 2018.1,2,3 HNSCC is an aggressive, genetically complex, and difficult to treat cancer.4 Furthermore, HNSCC is associated with high levels of psychological distress and compromised quality of life (QOL).5 As such, HNSCC patients are in need of improved treatment options.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
| 1 | Ferlay, J. et al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int. J. Cancer 144, 1941–1953 (2019). |
| 2 | Bray, F. et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 68, 394–424 (2018). |
| 3 | Ferlay, J. et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer (accessed 18 September 2020). IARC https://gco.iarc.fr/today (2018). |
| 4 | Alsahafi, E., Begg, K., Amelio, I. et al. Clinical update on head and neck cancer: molecular biology and ongoing challenges. Cell Death Dis 10, 540 (2019). |
| 5 | Johnson, D.E., Burtness, B., Leemans, C.R. et al. Head and neck squamous cell carcinoma. Nat Rev Dis Primers 6, 92 (2020). |
