IMpassion130: Expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schneeweiss A, Rugo H, Winer E, Barrios C, Iwata H, Dieras V, Loi S, Maiya V, Bond J, Lei G, Chui S, Adams S, Emens L, Schmid P. IMpassion130: Expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1068-1068. DOI: 10.1200/jco.2019.37.15_suppl.1068.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTriple-negative breast cancerTolerable safety profileCauses of withdrawalMonotherapy trialsPFS benefitSerious AEsSystemic corticosteroidsMedian FUSecondary endpointsNab-paclitaxelAdverse eventsPD-L1Peripheral neuropathyMedian timeSafety profileLonger FUSafety signalsBreast cancerSafety dataCumulative toxicityData cutAESIP3 studiesGr 3First-line (1L) ribociclib (RIB) plus letrozole (LET) for postmenopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer (ABC): MONALEESA-2 long-term safety results.
O'Shaughnessy J, Campone M, Andre F, Nusch A, Grischke E, Villanueva C, Marschner N, Winer E, Paluch-Shimon S, Rodriguez-Lorenc K, Hilliard A, Le Gac F, Ridolfi A, Hortobagyi G. First-line (1L) ribociclib (RIB) plus letrozole (LET) for postmenopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer (ABC): MONALEESA-2 long-term safety results. Journal Of Clinical Oncology 2019, 37: 1078-1078. DOI: 10.1200/jco.2019.37.15_suppl.1078.Peer-Reviewed Original ResearchGrade adverse eventsAdverse eventsLET armMedian durationHER2- advanced breast cancerLong-term safety resultsLong-term safety dataFirst-line ribociclibMONALEESA-2 studyCommon adverse eventsMo of exposureMONALEESA-2Data cutoffGI disordersPostmenopausal womenSafety profileProlonged QTQT intervalBreast cancerSafety dataSafety resultsSudden deathDose reductionPlaceboCommon reason