ImmunityBio Announces First Participants Have Been Enrolled in Lung-MAP Trial Studying Anktiva to Activate NK and T Cells in Non-Small Cell Lung Cancer

ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced today that the first participants have been enrolled in a study that is part of an 800-site master protocol trial for non-small cell lung cancer (NSCLC). The Lung Cancer Master Protocol trial (Lung-MAP) includes a study of Anktiva (N-803) plus Keytruda (pembrolizumab) versus investigator choice of standard-of-care chemotherapy in patients with non-small cell lung cancer (NSCLC) whose cancer has progressed after prior checkpoint-inhibitor-containing regimens. The study, which opened in March and currently includes nearly 200 sites across the U.S., will involve 478 patients when fully enrolled.

“The Lung-MAP master protocol is an important and innovative national multicenter trial and we’re grateful to be working with this national network to validate our hypothesis that both NK and T cells are needed to establish durable responses in patients with lung cancer,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “This large trial will provide valuable information on the role Anktiva could potentially play in bolstering the effectiveness of checkpoint inhibitors such as Keytruda. Since Anktiva acts by activating and proliferating both NK and memory T cells, the combination with a checkpoint inhibitor that takes the brakes off T cells could result in improved durable outcomes. This combination therapy will be offered as a treatment option to patients with tumors that do not have druggable mutations, which is the case for the majority of NSCLC patients.”

About the Anktiva (N-803) Lung-MAP Trial

The trial protocol is enrolling patients to a randomization schema of N-803 + pembrolizumab versus investigator choice of standard-of-care chemotherapy (docetaxel, gemcitabine, pemetrexed, or docetaxel + ramucirumab). The two cohorts are being studied independently: 1. Primary checkpoint inhibitor resistant patients, 2. Previous responders to checkpoint inhibitors who then subsequently progress.

The current standard-of-care for NSCLC without targetable mutations is pembrolizumab (Keytruda). This Lung-MAP study will look at how N-803 could potentially bolster the effectiveness of Keytruda for patients with non-targetable cancer cell mutations. The current standard of care for patients who progress on Keytruda is chemotherapy, which has significant toxicities associated with its use. Data presented by Wrangle and colleagues at ASCO 2021 showed the N-803/Keytruda combination as a chemotherapy-free alternative that has produced lower rates of adverse events than chemotherapy in the second-line setting https://ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.2596.