Matthew Kurian, Executive Committee Member at KYSCO, shared on LinkedIn:
“Gedatolisib may soon expand into PIK3CA-mutant HR+/HER2− metastatic breast cancer.
Celcuity has submitted an sNDA based on the PIK3CA-mutant cohort of VIKTORIA-1.
The results vs alpelisib + fulvestrant were impressive:
- Gedatolisib + fulvestrant + palbociclib: PFS 11.1 vs 5.6 months | HR 0.50
- Gedatolisib + fulvestrant: PFS 11.3 vs 5.6 months | HR 0.51
One takeaway seems pretty clear: palbociclib doesn’t appear to be adding much here. The doublet performed essentially the same as the triplet.
I also think many may trip up on the regulatory distinction:
- Gedatolisib is currently FDA approved in PIK3CA wild-type disease.
- This new application is for PIK3CA-mutant disease.
If approved, the more interesting question becomes: How do we choose among gedatolisib, capivasertib + fulvestrant, and inavolisib-based therapy? Importantly, these are not interchangeable populations or trial settings, particularly inavolisib.
Interestingly, in my discussions with colleagues, I’ve observed community oncologists adopting gedatolisib more readily than academic oncologists so far-which honestly surprised me.
The PI3K/AKT/mTOR space is getting crowded. The next challenge isn’t going to be whether we have options-it’s figuring out which option, for which patient, and when.”
You can also read:
Gedatolisib Enters ER+ Breast Cancer Care, But the Real Question Is How to Use It