Press release
New England Journal of Medicine Publishes Phase 3 ASCENT-04/KEYNOTE-D19 Results Supporting Trodelvy® Plus Keytruda® as a Potential New Standard of Care in First-line PD-L1+ Metastatic Triple-negative Breast Cancer
– Combination Reduced the Risk of Death or Disease Progression by 35% Versus Standard of Care in Frontline PD-L1+ Metastatic TNBC Setting – FOSTER CITY,
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– Combination Reduced the Risk of Death or Disease Progression by 35% Versus Standard of Care in Frontline PD-L1+ Metastatic TNBC Setting –\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine (NEJM) published the full results from the positive Phase 3 ASCENT-04/KEYNOTE-D19 study evaluating the combination of Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) in first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). ASCENT-04 successfully met its primary endpoint of progression-free survival (PFS) with a 35% (HR: 0.65; p1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.\n\n\nIn the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.\n\n\nDRUG INTERACTIONS\n\n\nUGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.\n\n\nUGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.\n\n\nPlease see full Prescribing Information, including BOXED WARNING.\n\n\nAbout Gilead and Kite Oncology\n\n\nGilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology...