Media Release
- A total of 171 head and neck squamous cell carcinoma (HNSCC) patients enrolled in randomised, multicentre Phase IIb trial evaluating efti in combination with pembrolizumab
- Efti has FDA Fast Track designation for first-line treatment of HNSCC
The Phase IIb trial enrolled 171 patients at over 30 centres across
A total of 138 patients with recurrent or metastatic HNSCC whose tumours express PD-L1 (CPS ≥1) have been enrolled into the 1:1 randomized Cohort A of the trial evaluating the safety and efficacy of 30mg of efti in combination with 400mg of KEYTRUDA® given every six weeks compared to 400mg of KEYTRUDA® alone. Patients in Cohort A whose tumors express PD-L1 (CPS >1) are also stratified by CPS 1-19 and CPS >20, and the clinical results for these three CPS groups will be evaluated.
Additionally, 33 patients with recurrent or metastatic HNSCC were enrolled into Cohort B to determine the efficacy and safety of the same combination therapy in patients with PD-L1 negative tumours (CPS <1). These patients are not expected to respond to KEYTRUDA® monotherapy, with a typical Overall Response Rate of up to 5%, and therefore were not randomized.1 Due to a higher number of patients with negative PD-L1 expression (CPS <1) who were eligible for and allocated to Cohort B and the number of patients in screening at the time of achieving the trial's enrollment goal, the trial enrolled 171 patients.
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. The primary analysis according to the trial protocol will be performed after all subjects have completed at least three cycles of treatment (18 weeks in total) or discontinued the trial, and all relevant data for the primary endpoint has been collected, cleaned, and analysed. The Company expects to report data from the trial in H1 CY2024.
Dr.
Dr.
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000 deaths reported in 2018.2,3,4 It is an aggressive, genetically complex, and difficult to treat cancer.5 Furthermore, HNSCC is associated with high levels of psychological distress and compromised quality of life (QOL).6 As such, HNSCC patients need improved treatment options.
Eftilagimod alpha was granted Fast Track designation by the FDA in
KEYTRUDA® is a registered trademark of
About Eftilagimod Alpha (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-ƴ 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 1st line HNSCC and in 1st line NSCLC from the
About
+61 (0)406 759 268; cstrong@citadelmagnus.com
U.S. Investors/Media:
+1 (631) 318 4000; chris.basta@immutep.com
________________________________
1 Burtness, B. et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score.
2 Ferlay, J. et al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int.
3 Bray, F. et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer
4 Ferlay, J. et al.
5 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).
6 Johnson, D.E., Burtness, B., Leemans, C.R. et al. Head and neck squamous cell carcinoma. Nat Rev Dis Primers 6, 92 (2020).
Source:
2023 GlobeNewswire, Inc., source