The medication was approved in combination with hormone therapy, with or without a CDK4/6 inhibitor.
Key Takeaways
- The FDA has approved gedatolisib for certain people with HR-positive/HER2-negative breast cancer.
- Patients taking gedatolisib must also be on a specific hormone therapy and may also receive a CDK4/6 inhibitor.
- Progression-free survival with the combination of all three medications was more than 9 months, compared to 2 months for hormone therapy alone.
The U.S. Food and Drug Administration (FDA) has approved the targeted medication gedatolisib (Revtorpyk®) for people with HR-positive/HER2-negative locally advanced or metastatic breast cancer.
Gedatolisib’s efficacy was demonstrated in the Phase 3 VIKTORIA-1 study.
The approval stipulates that the drug must be used in combination with fulvestrant, with or without a CDK4/6 inhibitor, palbociclib. Eligible patients must not have a PIK3CA mutation and must have progressed on or after treatment with at least one hormone therapy for metastatic breast cancer.
Gedatolisib is a PI3K/AKT/mTOR (PAM) inhibitor. The PI3K/AKT/mTOR (PAM) pathway is a key cellular signaling route that drives tumor growth and is a major contributor to resistance. It becomes an important target when first-line CDK4/6 inhibitors stop working. There are limited options for HR-positive/HER2-negative advanced breast cancer after CDK4/6 inhibitors stop working, and current PAM pathway drugs may have side effects that cause patients to want to disrupt treatment. Gedatolisib’s comprehensive pathway blockade and improved tolerability could meaningfully shift the standard of care for these patients.
Median progression-free survival (PFS) was 9.3 months with gedatolisib plus fulvestrant and palbociclib and 7.4 months for gedatolisib and fulvestrant, compared to 2 months with fulvestrant alone. Overall response rates were 32%, 28%, and 1%, respectively.
Potential adverse events from gedatolisib include mouth sores (stomatitis), skin reactions, and elevated blood sugar (hyperglycemia).
Thanks to research and the results from the phase 3 VIKTORIA-1 trial, patients with HR-positive/HER2-negative metastatic breast cancer have another treatment option, particularly when first-line CDK4/6 inhibitors stop working. Since this is a large and growing patient population, expanding the armamentarium of drugs to treat them is critical for improving outcomes.
