*November 2024*
The first patients have been dosed in 3 phase 3 trials evaluating various combinations of datapotamab deruxtecan (Dato-DXd) for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC).1
TROPION-Lung10 (NCT06357533) is investigating Dato-DXd plus rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, or rilvegostomig alone vs pembrolizumab (Keytruda) in patients with treatment-naive, locally advanced or metastatic, nonsquamous NSCLC with high PD-L1 expression and without actionable gene alterations.
TROPION-Lung14 (NCT06350097) will look at Dato-DXd plus osimertinib (Tagrisso) vs osimertinib alone in patients with previously untreated, locally advanced or metastatic EGFR-mutated nonsquamous NSCLC.
In TROPION-Lung15 (NCT06417814), investigators will assess Dato-DXd with or without osimertinib vs platinum-based doublet chemotherapy for the treatment of patients with locally advanced or metastatic, nonsquamous NSCLC with an EGFR mutation and whose disease progressed on osimertinib.
“These three trials in either high PD-L1 expressing or EGFR-mutated nonsquamous non–small cell lung cancer are critical to helping us understand the potential role of datopotamab deruxtecan in treating patients across different lines and types of lung cancer,” said Mark Rutstein, MD, global head of oncology clinical development, Daiichi Sankyo, said in a press release. “Our growing TROPION clinical program, which now consists of seven phase 3 trials demonstrates our commitment to understanding the full potential of datopotamab deruxtecan in lung cancer.”
The FDA is considering the biologics license application of Dato-DXd in patients with previously treated advanced nonsquamous NSCLC supported by data from TROPION-Lung01 (NCT04656652), and a Prescription Drug User Fee Act target action date of December 20, 2024, is planned.2
