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Daiichi Sankyo, AstraZeneca, Merck Partner on Phase III Trial of TROP2, PD-1 Inhibitor Combo

NEW YORK – Daiichi Sankyo and AstraZeneca said on Monday they are collaborating with Merck on a clinical trial evaluating their TROP2 inhibitor datopotamab deruxtecan with Merck's checkpoint inhibitor pembrolizumab (Keytruda).

The Phase III trial will evaluate the combination of datopotamab deruxtecan and pembrolizumab versus pembrolizumab alone in treatment-naïve patients with PD-L1-high advanced or metastatic non-small cell lung cancer, who lack actionable genomic alterations. The global, randomized trial will involve up to 740 patients and track their progression-free and overall survival on treatment.

Daiichi Sankyo, AstraZeneca, and Merck previously conducted a Phase Ib trial of datopotamab deruxtecan and pembrolizumab with or without chemotherapy in patients with advanced or metastatic NSCLC.

"Entering into this second clinical trial collaboration is based on encouraging results in an ongoing Phase Ib study and advances development of datopotamab deruxtecan into a Phase III study in first-line metastatic non-small cell lung cancer," Gilles Gallant, global head of oncology development and oncology R&D at Daiichi Sankyo, said in a statement. "In this specific trial, we will evaluate whether combining our TROP2 directed ADC with an anti-PD-1 therapy improves outcomes in patients with previously untreated advanced non-small cell lung cancer with no actionable genomic alterations."

Daiichi Sankyo and AstraZeneca are also studying datopotamab deruxtecan in a Phase II trial in NSCLC patients with certain actionable alterations, including mutations in EGFR, ALK, ROS1, NTRK, BRAF, MET, or RET.