GENEVA - Roche's investigational drug inavolisib has delivered promising results in a critical Phase III study, potentially marking a significant advancement in the treatment of hormone receptor-positive breast cancer. The INAVO120 study, which focused on patients with endocrine-resistant, locally advanced or metastatic PIK3CA-mutated forms of the disease, found that inavolisib combined with palbociclib and fulvestrant significantly improved progression-free survival (PFS) compared to existing treatments.
The trial specifically targeted the mutated PI3Kα protein through the dysregulated PI3K pathway that contributes to tumor growth and resistance to hormonal therapies. The combination therapy outperformed fulvestrant alone for endocrine-resistant tumors, indicating a clinically meaningful PFS benefit when used as a first-line treatment.
Levi Garraway, associated with Genentech, emphasized the importance of this development by stating that it "represents a significant advancement in treatment" for patients with advanced HR-positive, HER2-negative breast cancer harboring PIK3CA mutations.
The success of the INAVO120 study on primary endpoints offers new hope for better management of this particular breast cancer subtype. With ongoing follow-up, researchers aim to confirm the observed positive trends in overall survival.
Genentech, part of the Roche Group, is continuing its clinical program with additional studies, including INAVO121 and INAVO122. These studies are part of a broader effort to validate this therapeutic approach further and expedite patient access to what could become a new standard of care for those affected by this challenging form of breast cancer.
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