Our BRA-Bladder 🇧🇷 (just out in JCO Global Oncology): huge gap between guidelines and reality in localized bladder cancer across middle-income settings. Pts aren’t failing guidelines — systems are failing patients. Access > innovation in many settings.
https://t.co/XnVFX4wrmu
7–1–1 ODAC vote for capivasertib in PTEN-deficient mHSPC.
Modest rPFS (HR 0.81), OS negative/immature, ↑ toxicity.
Are we lowering the bar for biomarker-driven approvals?
This feels like biology > clinical benefit.
Let’s see how the FDA spins the label.
ODAC voted 7-1-1 today in favor of capivasertib + abiraterone for PTEN-deficient mHSPC.
The vote came despite a negative immature OS readout, which is the real story.
CAPItello-281 (n=1012): 🎯 PTEN-deficient mHSPC, biomarker-selected
📈 rPFS 33.2 vs 25.7 mo, HR 0.81, P=0.034
❓ OS HR 0.90, P=0.40 (immature, 26.4% maturity) ⚠️ Serious AEs 42.5% vs 26.0%
Worth watching how the FDA responds and how they label the indication, including which companion PTEN assay is required.
Adoption in clinic will hinge on testing access and proactive AE management as much as the label itself.
📄 https://t.co/jynqMt5EGT
#ProstateCancer #mHSPC #GUonc #ODAC #FOAMonc
Always a privilege to watch Dr. @montypal present — especially in a year with so many remarkable developments at #ASCOGU26
Proud to have learned from him up close during my time at @cityofhope, and hoping now to generate high-quality data with my skilled Brazilian colleagues.
Finally IO/IO emerging as an option for fav risk disease! Selection is key and an unmet need (biomarkers), but not considering this strategy deprive some fav risk pts of having long term benefits.
As ADCs come into play and precision medicine evolves, it becomes more important to improve patient selection for therapies in aUC. Great study on the expression of TROP2 and NECTIN-4, by @Markuseckstein3 and colleagues. Maybe ADCs are not for everyone.
https://t.co/iWNXtMS0lg
Very nice discussion today around papillary renal cell carcinoma with the @cityofhope dream team represented by the amazing @montypal. Congrats @glaucia_asc for the presentation 🇧🇷🇺🇸
Excellent mRCC discussion today with dear friends at @LACOG_group meeting (GU Review). Great to have @BourlonMaite 🇲🇽 on board sharing her thoughts as well!
“Why It Takes Forever to Get a Doctor's Appointment | Time”. What a great summary of the endless storm we face daily. By @ilanayurkiewicz https://t.co/S4glGXk6fY