AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo have announced the first patient has been dosed in the TROPION-Lung17 Phase 3 trial, a landmark study that marks the first time an antibody-drug conjugate (ADC) is being evaluated using a prospective, AI-powered biomarker in lung cancer.
The trial compares DATROWAY® (datopotamab deruxtecan) against traditional docetaxel chemotherapy in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
The study specifically targets patients whose tumors are "TROP2 NMR positive," a new classification identified by AstraZeneca’s Quantitative Continuous Scoring (QCS) computational pathology platform.
Unlike traditional biomarkers that simply measure the presence of a protein, the TROP2 NMR (Normalized Membrane Ratio) biomarker uses artificial intelligence to measure the ratio of TROP2 protein on the cell surface versus inside the cell.
Retrospective data from earlier trials, including TROPION-Lung01, suggested that patients with this specific TROP2 distribution pattern experienced significantly better outcomes when treated with DATROWAY.
The TROPION-Lung17 study represents a major push toward precision medicine for second-line NSCLC, a setting where docetaxel has remained the static standard of care for decades.
By using an investigational AI-powered companion diagnostic—which previously received FDA Breakthrough Device Designation—the partners hope to prove that DATROWAY can offer a superior, targeted alternative for the roughly 60–70% of nonsquamous NSCLC patients who may be biomarker-positive.
DATROWAY is currently being evaluated in a massive clinical program consisting of nine Phase 3 trials in NSCLC alone, including combinations with immunotherapy (AVANZAR) and targeted therapies like Tagrisso® (osimertinib).