2019
IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schmid P, Adams S, Rugo H, Schneeweiss A, Barrios C, Iwata H, Dieras V, Henschel V, Molinero L, Chui S, Husain A, Winer E, Loi S, Emens L. IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab- paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1003-1003. DOI: 10.1200/jco.2019.37.15_suppl.1003.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerOverall survivalPD-L1OS analysisTriple-negative breast cancerECOG PS 0Median overall survivalPrimary PFS analysisPD-L1 testingPhase III studyCo-primary endpointsEligible ptsOS benefitData cutoffIII studyNab-paclitaxelPS 0AtezoBreast cancerPFS analysisPlaceboNP armTumor tissueSafety updateOS data
2017
Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A.
Adams S, Schmid P, Rugo H, Winer E, Loirat D, Awada A, Cescon D, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O'Shaughnessy J, Loi S, Paluch-Shimon S, Card D, Zhao J, Karantza V, Cortes J. Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A. Journal Of Clinical Oncology 2017, 35: 1008-1008. DOI: 10.1200/jco.2017.35.15_suppl.1008.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTreatment-related AEsPD-L1 expressionPD-L1Manageable safetyTriple-negative breast cancerECOG PS 0Subset of ptsDisease control ratePhase 2 studyPoor prognostic factorEfficacy/safetyBest overall responseCohort A.Evaluable ptsKEYNOTE-012Median DoRMedian PFSPrior chemotherapyData cutoffPembrolizumab monotherapyDurable responsesMetastatic diseasePrior linesPS 0
2014
A randomized phase 2 trial comparing efficacy of the combination of the PARP inhibitor olaparib and the antiangiogenic cediranib against olaparib alone in recurrent platinum-sensitive ovarian cancer.
Liu J, Barry W, Birrer M, Lee J, Buckanovich R, Fleming G, Rimel B, Buss M, Nattam S, Hurteau J, Luo W, Quy P, Obermayer E, Whalen C, Lee H, Winer E, Kohn E, Ivy S, Matulonis U. A randomized phase 2 trial comparing efficacy of the combination of the PARP inhibitor olaparib and the antiangiogenic cediranib against olaparib alone in recurrent platinum-sensitive ovarian cancer. Journal Of Clinical Oncology 2014, 32: lba5500-lba5500. DOI: 10.1200/jco.2014.32.18_suppl.lba5500.Peer-Reviewed Original ResearchProgression-free survivalPartial responseComplete responseHazard ratioOvarian cancerRecurrent platinum-sensitive ovarian cancerMedian progression-free survivalPrior anti-angiogenic therapyPARP inhibitorsPlatinum-sensitive ovarian cancerRandomized phase 2 trialOpen-label studyRecurrent ovarian cancerPhase 2 trialPhase 1 studyExploratory subgroup analysisAnti-angiogenic therapyCombination of cediranibPARP inhibitor olaparibMeasurable diseaseRECIST 1.1Radiographic progressionPFS eventsPS 0Oral combination
2011
P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen.
Tolaney S, Burris H, Gartner E, Mayer I, Saura C, Maurer M, DeCillis A, Ruiz-Soto R, Lager J, Winer E, Krop I. P1-17-02: A Phase 1/2 Study of SAR245408 (S08) in Combination with Trastuzumab (T) or Paclitaxel (P) and T in Patients with HER2+ Metastatic Breast Cancer (MBC) Who Progressed on a Previous T-Based Regimen. Cancer Research 2011, 71: p1-17-02-p1-17-02. DOI: 10.1158/0008-5472.sabcs11-p1-17-02.Peer-Reviewed Original ResearchPhase 1/2 studyMetastatic breast cancerOverall response rateArm 1Arm 2Epigastric painMulticenter phase 1/2 studyPan-PI3K inhibitorECOG PS 0Preliminary PK dataDose-escalation designAge 55 yrPhase 2 portionDifferent dose levelsPhase 1PI3K pathwayDisease refractoryFemale ptsMost HER2Recurrent HER2MBC patientsMetastatic diseaseAdverse eventsPeripheral neuropathyPS 0