NCI to study Anktiva + Keytruda as a chemo-free NSCLC therapy in 700-site Lung-MAP clinical trial

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The Lung Cancer Master Protocol public-private partnership—which includes the NCI, the National Clinical Trials Network Cooperative Groups (SWOG, ECOG-ACRIN, Alliance, and NRG), Friends of Cancer Research, and the Foundation for the National Institutes of Health—will study the IL-15 receptor superagonist complex Anktiva (N-803) in the Lung-MAP clinical trial. 

Anktiva is sponsored by ImmunityBio, Inc.

Anktiva will be given in combination with Merck’s Keytruda (pembrolizumab) 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, as is the case for the majority of NSCLC patients.

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.

The trial protocol will enroll patients to a randomization schema of Anktiva + Keytruda versus investigator choice of standard-of-care chemotherapy (docetaxel, gemcitabine, pemetrexed, or docetaxel + ramucirumab). Two cohorts are being studied independently: primary checkpoint inhibitor resistant patients, and previous responders to checkpoint inhibitors who then subsequently progress.

This Lung-MAP study will look at how Anktiva 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 the study developers at ASCO 2021 showed the Anktiva/Keytruda combination as a chemotherapy-free alternative that has produced lower rates of adverse events than chemotherapy in the second-line setting.

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