On October 4, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported the Lung Cancer Master Protocol (Lung-MAP) public-private partnership—which includes the National Cancer Institute (NCI), the National Clinical Trials Network (NCTN) Cooperative Groups (SWOG, ECOG-ACRIN, Alliance, and NRG), Friends of Cancer Research, and the Foundation for the National Institutes of Health (FNIH)—reported that it will study the company’s IL-15 receptor superagonist complex, N-803 (Anktiva), in the Lung-MAP trial (Press release, ImmunityBio, OCT 4, 2021, View Source [SID1234590733]). Anktiva will be given in combination with Merck’s pembrolizumab (Keytruda) to participants with non-small cell lung cancer who have failed previous treatments. The combination therapy will be offered as a treatment to patients with tumors that do not have mutations targetable with a drug, which is the case for the majority of NSCLC patients.

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The Lung-MAP trial is open at more than 700 sites in the U.S. When fully enrolled, this trial group will include 478 patients.

"While some patients with lung tumors have targetable genetics, the majority do not, and for them there are fewer treatment options," said John Wrangle, M.D., one of the researchers at the Medical University of South Carolina who developed the study. "The Lung-MAP study aims to change that by combining different therapies such as Anktiva and Keytruda in an effort to discover highly effective and targeted therapies for these patients."

About the N-803 (Anktiva) Lung-MAP Trial
The trial protocol will enroll 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. Current standard of care for patients who progress on Keytruda is chemotherapy with significant toxicities associated. Data presented by Wrangle and colleagues at ASCO (Free ASCO Whitepaper) 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.

"Despite the tremendous progress we’ve made over the last few years, lung cancer continues to claim more than 130,000 lives annually, making it one of the deadliest cancers," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "Lung-MAP is a game-changing program because it tests the efficacy of multiple therapeutics and allows patients with targetable tumors to receive the best treatment based on their biomarkers and it gives patients without biomarkers access to treatments they would not normally be able to have without gene mutations."

Lung cancer is the second most common cancer in the United States. In 2021, in the United States alone it is estimated that 235,760 new cases of lung cancer will be diagnosed, and 131,880 deaths will be attributed to the disease.1 Non-small cell lung cancer accounts for 85 percent of all lung cancer diagnoses and there are very few successful treatment options for these patients once the cancer spreads beyond the lungs.2 To learn more about ImmunityBio’s Lung-MAP study, please visit View Source