ANKTIVA® in Combination with the AdHER2DC Cancer Vaccine to be Evaluated as a Therapy to Control Endometrial Cancer

ImmunityBio, Inc., today announced the opening of the National Cancer Institute-sponsored Phase 1/2 QUILT 502 clinical trial, which will study ANKTIVA® together with the investigational AdHER2DC vaccine in individuals with HER2-expressing endometrial cancer.

It marks the latest trial involving ANKTIVA, the company’s IL-15 superagonist immune enhancer. The aim of the trial is to evaluate ANKTIVA as an agent to replace the short-term activity of checkpoint inhibitor immunotherapies with long-term effectiveness. 

Endometrial cancer is the most common gynecological cancer in the U.S. and affects more than 65,000 women each year, with incidence peaking around 50-60 years of age. The 5-year overall survival rate in patients with metastasis is around 20 percent; treatment options after the second-line treatment are limited.

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 single agent AdHER2DC demonstrated a safety profile and immunogenicity in a phase 1 clinical trial.

The U.S. FDA recently approved ANKTIVA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors.

“We are pleased to partner with the NCI on this important cancer control study involving ANKTIVA, which has demonstrated in clinical trials that activation of memory T cells may help deliver long-duration responses well beyond that of checkpoint inhibitors alone,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on August 6, 2024.

“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.”

Phase 1 of the open-label, two-arm Phase 1/2 study will determine the recommended dose of pembrolizumab, lenvatinib, ANKTIVA, and AdHER2DC in participants with HER2-positive endometrial cancer.

The Phase 2 portion of the study will assess the efficacy of the combination of pembrolizumab, lenvatinib, ANKTIVA, and the AdHER2DC vaccine in qualified participants as determined by the proportion of participants without disease progression at six months. The study will enroll 60 subjects and is expected to be completed in 2026.

ImmunityBio says these studies, along with the recent approval of ANKTIVA for bladder cancer, signal the advent of the era of cytokines as the next generation of immunotherapies.