AstraZeneca (AZ) and Daiichi Sankyo have announced positive results from a late-stage study of their investigational TROP2-targeting antibody drug conjugate, datopotamab deruxtecan, in certain lung cancer patients.
The phase 3 TROPION-Lung01 trial has been evaluating the drug versus docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had received at least one prior therapy.
The study met one of its dual primary endpoints, with datopotamab deruxtecan demonstrating a statistically significant improvement in progression-free survival compared with standard chemotherapy.
The data for the second dual primary endpoint of overall survival was immature at the time of analysis, the companies said, but added that an “early trend” was observed in favour of datopotamab deruxtecan.
An estimated 2.2 million people worldwide are diagnosed with lung cancer each year, with NSCLC accounting for up to 85% of all lung cancer cases. TROP2 is a protein highly expressed in a large majority of lung cancers.
While immunotherapy and targeted therapies have improved outcomes in the first-line metastatic setting, most patients eventually experience disease progression and receive chemotherapy.
Susan Galbraith, executive vice president, oncology research and development, AZ, said: “With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy.
“These first phase 3 trial results from the datopotamab deruxtecan clinical programme provide compelling evidence for the potential role this TROP2-directed antibody drug conjugate can play in treating patients with lung cancer.”
Ken Takeshita, global head, oncology research and development, Daiichi Sankyo, added: “We are encouraged by the statistically significant results of the dual primary endpoint of progression-free survival seen with datopotamab deruxtecan and look forward to the final overall survival analysis. We plan to share this data with regulatory authorities to discuss next steps.”
The results come just a month after AZ shared positive data from a phase 3 study of its Tagrisso (osimertinib) as an additional treatment for patients with early-stage epidermal growth factor receptor-mutated (EGFRm) NSCLC who had undergone surgery to remove their primary tumour.
The drug was associated with a 51% reduction in risk of death compared to placebo in both the primary analysis population (patients with stages 2 to 3a EGFRm NSCLC) and in the overall trial population (stages 1b to 3a).