AstraZeneca (AZN) said early Tuesday that Tagrisso plus Orpathys in a phase 3 trial showed a "statistically significant and highly clinically meaningful improvement" in progression-free survival versus tagrisso alone in a trial of newly diagnosed lung cancer patients.
The SANOVO Phase 3 trial included 326 patients in China who had not previously been treated for advanced lung cancer with specific genetic changes, according to AstraZeneca.
The benefit was seen in both the high MET and intention-to-treat trial populations, the company said. The combination also showed what the company described as very encouraging clinical benefit in overall survival, which is a secondary endpoint, although the trial will continue to follow patients.
The safety profile for Tagrisso plus Orpathys was consistent with the known profiles of each medicine, and no new safety findings emerged.
The results from the trial reinforce tagrisso as the backbone therapy across epidermal growth factor receptor-mutated lung cancer, the company said.