85.5% DCR with the REVTORPYK triplet vs 39% with fulvestrant1
DCR (CR+PR+SD) was an exploratory analysis. SD can reflect the natural history of disease rather than a direct therapeutic effect. DCR may not be directly correlated to efficacy outcomes and no conclusions of statistical significance can be drawn.2,3
Subgroup analyses were exploratory, descriptive, and no formal statistical testing was conducted.
PFS subgroup analysis was post hoc, not prespecified, and not powered for statistical significance. Exploratory analyses are not controlled for multiplicity and results should be interpreted descriptively.
Median durations of prior CDK4/6i exposure were 21.7 and 20.0 months in the REVTORPYK triplet and fulvestrant groups, respectively.4
NOTE: Data are immature and results are not adjusted for crossover. Follow-up is ongoing.
Adapted from Hurvitz SA et al. J Clin Oncol. 2026;44(12):1108-1119.
77% DCR with the REVTORPYK doublet vs 39% with fulvestrant1
DCR (CR+PR+SD) was an exploratory analysis. SD can reflect the natural history of disease rather than a direct therapeutic effect. DCR may not be directly correlated to efficacy outcomes and no conclusions of statistical significance can be drawn.2,3
Subgroup analyses were exploratory, descriptive, and no formal statistical testing was conducted.
PFS subgroup analysis was post hoc, not prespecified, and not powered for statistical significance. Exploratory analyses are not controlled for multiplicity and results should be interpreted descriptively.
Median durations of prior CDK4/6i exposure were 18.1 and 20.0 months in the REVTORPYK doublet and fulvestrant groups, respectively.4
NOTE: Data are immature and results are not adjusted for crossover. Follow-up is ongoing.
Adapted from Hurvitz SA et al. J Clin Oncol. 2026;44(12):1108-1119.
NR=not reached.
NR=not reached.
IMPORTANT SAFETY INFORMATION
Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.
Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.
Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.
Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.
Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
ADVERSE REACTIONS
REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils.
REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.
REVTORPYK is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
REVTORPYK is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Please see the full Prescribing Information for REVTORPYK.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Celcuity at 877-4-CELCUITY (877-423-5284).
References: 1. Hurvitz SA, Layman RM, Curigliano G, et al. Gedatolisib plus fulvestrant, with & without palbociclib, vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer: first results from VIKTORIA-1. Presented at: ESMO Congress; October 17-21, 2025; Berlin, Germany. 2. Delgado A, Guddati AK. Clinical endpoints in oncology—a primer. Am J Cancer Res. 2021;11(4):1121-1131. 3. U.S. Food & Drug Administration (FDA). Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry. 2018. Updated May 7, 2020. Accessed July 12, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-endpoints-approval-cancer-drugs-and-biologics 4. Hurvitz SA, Layman RM, Curigliano G, et al. VIKTORIA-1 trial of gedatolisib plus fulvestrant with or without palbociclib in hormone receptor-positive/HER2-/PIK3CA wild-type advanced breast cancer. J Clin Oncol. 2026;44(12):1108-1119. 5. Pistilli B, Layman RM, Curigliano G, et al. Gedatolisib, a multitarget PI3K/AKT/mTOR inhibitor, plus fulvestrant with or without palbociclib for second-line treatment of patients with HR+/HER2-/PIK3CA-WT advanced breast cancer: updated results from the randomized, phase 3 VIKTORIA-1 trial. Presented at: San Antonio Breast Cancer Symposium; December 9-12, 2025; San Antonio, TX. 6. Revtorpyk. Prescribing information. Celcuity Inc; 2026.