ImmunityBio announced in August 2024 that a clinical trial to study ANKTIVA and the investigational AdHER2DC vaccine in individuals with HER2-expressing endometrial cancer has opened. The trial is sponsored by the US National Cancer Institute (NCI) and seeks to assess the safety and preliminary clinical efficacy of the AdHER2DC vaccine in combination with ANKVITA, pembrolizumab, and lenvatinib before a larger study. Endometrial cancer is the most common gynaecological cancer in the US, affecting more than 65,000 women every year. The 5-year overall survival rate in patients with metastasis is “around 20%”, and treatment options after the second-line treatment are “limited”.
ANKTIVA and AdHER2DC
ANKTIVA is ImmunityBio’s IL-15 superagonist immune enhancer; it was approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumours in April 2024. The AdHER2DC vaccine targets the HER2 protein, which is elevated in 30% of patients with endometrial cancer and in more than 50% of “high-risk subtypes”. The autologous vaccine uses participants’ blood cells that are drawn through apheresis.
The vaccine, a dendritic cell vaccine that is “transduced with an adenoviral vector expressing extracellular domain and transmembrane domain of HER2”, proved to be “well tolerated” and demonstrated “preliminary clinical benefit” in 21 evaluable patients. In this trial, all participants will receive the vaccine and the FDA-approved drugs (pembrolizumab and lenvatinib), and some will receive ANKTIVA.
The study
The Phase I/II study is an open-label, two-arm study; the first phase will determine the recommended dose of each intervention in participants with HER2 positive endometrial cancer. The Phase II section will assess the efficacy of the combination in qualified participants. The study will enrol 60 subjects and is scheduled to complete in 2026. Dr Patrick Soon-Shiong, Executive Chair and Global Scientific and Medical Officer at ImmunityBio, is “pleased to partner with the NCI” on the “important” study.
“We are hopeful that the AdHER2DC investigational vaccine plus ANKTIVA will ‘rescue’ the checkpoint inhibitor pembrolizumab and kinase inhibitor lenvatinib and lead to an improved response compared with the current standard of care in this high-risk population.”
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