KOL Engagement + Insights Director @Celcuity •Advocate for patients + cancer research •Infinitely curious •Grateful Mom •Traveler •Lover of nature + animals.
We are very pleased to announce that Celcuity has submitted its supplemental NDA to the FDA for REVTORPYK™ (gedatolisib. You can find more details in the press release: https://t.co/2CMkh3Gmbs
$CELC
REVTORPYK™ (gedatolisib) in combination with fulvestrant, w/or/wo palbociclib, is recommended by the NCCN Clinical Practice Guidelines in Oncology as a preferred Category 1 second-line and/or subsequent-line therapy. Details in our press release: https://t.co/cIjr1i0Wq1 $CELC
#NEWS: The FDA has approved our targeted therapy for patients with HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer following progression on prior therapy. Learn more: https://t.co/5CRq2e4wiO
#FDAApproval#BreastCancer
$CELC
Gedatolisib is now @US_FDA ✅ based off VIKTORIA-1: PhIII, Gedato (PI3K/mTORi) + Fulv +/- Palbo vs. Fulv in HR+ after one line of ET in HR+
- mPFS: 9.3mos w/triplet vs. single agent Fulv (HR: 0.24)
- mPFS: 7.4mos w/doublet vs. single agent Fulv (HR: 0.33)
- AEs (IV/⏰ toxicity)
#OncTwitter #bcsm
Celcuity reported detailed results for the PIK3CA mutant cohort of the pivotal Phase 3 VIKTORIA-1 trial in patients with HR+/HER2- advanced breast cancer. Read our press release here: https://t.co/8c8yIR8p5R
VIKTORIA-1 PIK3CA-mutant cohort (LBA1008) dropped this morning at #ASCO26.
Gedatolisib roughly doubled PFS vs alpelisib + fulvestrant after CDK4/6i progression:
• Geda doublet: 11.3 mo
• Geda triplet: 11.1 mo
• Alpelisib + fulv: 5.6 mo
ORR 48.9% (triplet) / 35.7% (doublet)
IMO Three things worth sitting with:
1️⃣ This beat an active comparator: Piqray, not fulvestrant alone. That’s a harder bar than the WT cohort cleared, and it makes the win more meaningful.
2️⃣ The doublet matched the triplet on PFS (11.3 vs 11.1). Palbociclib deepened responses (ORR 48.9 vs 35.7) but didn’t extend PFS in this readout. Might be beneficial to start with the triplet to increase the likelihood of a response and then transition to a maintenance doublet
3️⃣ The quiet headline is tolerability: hyperglycemia reported lower than anything in this class to date. That’s been the Achilles’ heel of PAM inhibition since SOLAR-1.
This is the first PAM inhibitor positioned to deliver regardless of PIK3CA status. BIG WIN 👏🏼👏🏼👏🏼
#bcsm
Late last week, Celcuity announced positive topline VIKTORIA-1 data in the PIK3CA-mutant cohort, with gedatolisib plus fulvestrant and palbociclib showing a clinically meaningful PFS improvement versus alpelisib plus fulvestrant. The update adds even more weight to this discussion as the post CDK4/6 HR+/HER2- breast cancer landscape continues to evolve.
Dr. @elmayermd & Dr. @mchayleh, discuss what clinicians need to watch as triplets, doublets, sequencing, toxicity, and biomarker driven strategies move closer to practice.
More updates coming post ASCO on From Podium to Practice highlighting Viktoria-1 & much more!
Full Discussion:
https://t.co/MJni1f4OBV
Today, we announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with HR+/HER2- PIK3CA mutant advanced breast cancer. https://t.co/9iBrTNsRQm
We are proud to announce publication in the Journal of Clinical Oncology of results from the Phase 3 VIKTORIA-1 clinical trial. Read more here: https://t.co/5tT0Bm67OU $CELC #gedatolisib
Less than 2 months to #ASCO25! Join us to🗣️the current SoC➕how the data from #ASCO25 will change/reinforce our practice!
InPerson: May 31st, 2025
Location📍Marriott Marquis
Time: 6:30-9:00PM
Register https://t.co/w6VfiEEw4g
#AdvInOnc25#bcsm#OncTwitter#gism#lcsm#gusm
BREAKWATER Ph3 showing an incredible improvement in ORR by 21% and doubling of the duration of response with the addition of FOLFOX to enco+cetux in BRAFV600E MT CRC. 👏🏻🙌🏻 Congrats to my forever mentor @skopetz for changing the standard of care in 1L CRC!!#ASCOGI25@FightCRC