Gilead Sciences has a lot of its oncology ambitions riding on Trodelvy’s success beyond its existing approvals. While investors have been waiting with bated breath for results from a breast cancer trial to gauge the drug’s potential, Gilead’s new announcement isn’t giving them too much confidence in CEO Daniel O’Day’s big cancer plans.
In heavily pretreated patients with HR-positive, HER2-negative metastatic breast cancer, Trodelvy topped chemotherapy at staving off disease progression or death in the phase 3 TROPiCS-02 study, Gilead unveiled Monday.
The clinical trial hit its primary endpoint, with a “statistically significant” improvement in progression-free survival (PFS), Gilead said. But on whether the benefit is “clinically meaningful,” which investors are keeping a closer eye on, Gilead came short of offering a straightforward answer.
“There is a broad range of views on what is ‘clinically meaningful’ in this population,” Gilead said in a securities filing. “We are evaluating the data and will explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients.”
Gilead’s descriptions are raising “considerable uncertainty about” whether the results are actually clinically meaningful for patients, RBC Capital Markets analyst Brian Abrahams wrote in a Monday note.