Datroway’s Tropion-Lung01 do-over?

AstraZeneca, still awaiting the key catalyst of Datroway’s Avanzar study, recently took this TROP2-targeting ADC into a phase 3 trial in the tough setting of relapsed non-small cell lung cancer. The trial – Datroway’s 15th pivotal – is called Tropion-Lung17, and began last October, but has only just been revealed in a new clinicaltrials.gov listing. It’s notable for appearing to be a do-over of Datroway’s failed Tropion-Lung01 study, which led to the withdrawal of a US filing in 2024; a key difference here is that Tropion-Lung17 mandates TROP2 positivity on patients’ tumours, while Tropion-Lung01 made no requirement for TROP2 expression. It’s likely that the new trial assesses TROP2 positivity using Astra’s vaunted QCS (quantitative continuous scoring) assay, which measures antibody internalisation, and is also being used in Avanzar, a first-line NSCLC trial whose readout has been delayed to the first half of this year. Tropion-Lung17 shows Astra refusing to take its foot off the gas with Datroway; this is despite the problems of Tropion-Lung01, and the Daiichi Sankyo-originated molecule’s association with lung toxicity problems, which recently led to the Tropion-Lung15 study being put on EU halt.

Selected phase 3 trials of Datroway

Note: ILD=interstitial lung disease; Source: OncologyPipeline.