Skip to main content
Premium Trial:

Request an Annual Quote

Daiichi Sankyo, AstraZeneca Begin Phase III Trial of TROP2 Inhibitor, Keytruda in NSCLC

NEW YORK – Daiichi Sankyo and AstraZeneca on Monday said they've started a Phase III trial evaluating the TROP2 inhibitor datopotamab deruxtecan plus Merck's Keytruda (pembrolizumab) in patients with advanced non-small cell lung cancer with PD-L1 expression in less than 50 percent of tumor cells and without actionable genomic alterations.

In the global TROPION-Lung07 trial, the companies are exploring the combination as a first-line therapy in previously untreated NSCLC patients. Researchers will randomize nearly 1,000 patients to receive one of three combination treatments: datopotamab deruxtecan plus Keytruda and chemotherapy; datopotamab deruxtecan plus Keytruda; and Keytruda plus platinum chemo. The primary endpoints are progression-free survival and overall survival.

"The combination of datopotamab deruxtecan, with a checkpoint inhibitor with or without chemotherapy, has shown increased activity and a manageable safety profile in early trials including TROPION-Lung02," AstraZeneca Chief Medical Officer Cristian Massacesi said in a statement. "With this initiation, TROPION-Lung07 becomes the third Phase III trial in our evaluation of these investigational combinations for the first-line treatment of patients with non-small cell lung cancer across PD-L1 segments and tumor histologies."

Daiichi Sankyo and AstraZeneca are also studying datopotamab deruxtecan in a Phase II trial involving NSCLC patients with actionable alterations in EGFR, ALK, ROS1, NTRK, BRAF, MET, or RET. In a Phase III trial, the firms are studying the drug in previously untreated patients with locally recurrent, inoperable, or metastatic triple-negative breast cancer who are ineligible for PD-1/PD-L1 immune checkpoint inhibitors.