2019
Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study
Adams S, Loi S, Toppmeyer D, Cescon DW, De Laurentiis M, Nanda R, Winer EP, Mukai H, Tamura K, Armstrong A, Liu MC, Iwata H, Ryvo L, Wimberger P, Rugo HS, Tan AR, Jia L, Ding Y, Karantza V, Schmid P. Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 405-411. PMID: 30475947, DOI: 10.1093/annonc/mdy518.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPositive metastatic triple-negative breast cancerTreatment-related adverse eventsTriple-negative breast cancerDisease control rateObjective response rateFirst-line therapyProgression-free survivalAdverse eventsPD-L1Stable diseasePembrolizumab monotherapyOverall survivalCohort BControl rateBreast cancerResponse ratePD-L1 combined positive scoreCentral nervous system metastasesGrade 4 adverse eventsMedian progression-free survivalStandard first-line treatmentEnd pointGrade 3 severityManageable safety profilePembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study
Adams S, Schmid P, Rugo HS, Winer EP, Loirat D, Awada A, Cescon DW, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O’Shaughnessy J, Loi S, Paluch-Shimon S, Tan AR, Card D, Zhao J, Karantza V, Cortés J. Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 397-404. PMID: 30475950, DOI: 10.1093/annonc/mdy517.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerDisease control ratePD-L1Positive populationPembrolizumab monotherapyMetastatic diseaseControl rateBreast cancerTreatment-related adverse eventsEnd pointManageable safety profileObjective response ratePrimary end pointSecondary end pointsProgression-free survivalSubset of patientsDurable antitumor activityDuration of responseLine of treatmentEligible patientsMedian OSMedian PFSAdverse eventsMedian duration
2018
A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer
Schöffski P, Cresta S, Mayer IA, Wildiers H, Damian S, Gendreau S, Rooney I, Morrissey KM, Spoerke JM, Ng VW, Singel SM, Winer E. A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer. Breast Cancer Research 2018, 20: 109. PMID: 30185228, PMCID: PMC6125885, DOI: 10.1186/s13058-018-1015-x.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityPhase Ib studyMetastatic breast cancerAdverse eventsBreast cancerIb studyResultsSixty-nine patientsAntitumor activityManageable safety profileAdvanced breast cancerSerious adverse eventsPreliminary antitumor activityDrug-drug interactionsEvaluation of safetySecondary endpointsPartial responseComplete responseDose escalationRandomized studySafety profilePatientsBevacizumabTrastuzumabPictilisibLetrozole
2017
Phase 2 study of pembrolizumab as first-line therapy for PD-L1–positive metastatic triple-negative breast cancer (mTNBC): Preliminary data from KEYNOTE-086 cohort B.
Adams S, Loi S, Toppmeyer D, Cescon D, De Laurentiis M, Nanda R, Winer E, Mukai H, Tamura K, Armstrong A, Liu M, Iwata H, Ryvo L, Wimberger P, Card D, Ding Y, Karantza V, Schmid P. Phase 2 study of pembrolizumab as first-line therapy for PD-L1–positive metastatic triple-negative breast cancer (mTNBC): Preliminary data from KEYNOTE-086 cohort B. Journal Of Clinical Oncology 2017, 35: 1088-1088. DOI: 10.1200/jco.2017.35.15_suppl.1088.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerPositive metastatic triple-negative breast cancerFirst-line therapyCombined positive scorePD-L1 combined positive scoreTreatment-related AEsPD-L1Cohort BStandard first-line treatmentEnd pointTriple-negative breast cancerECOG PS 0Antitumor activityManageable safety profilePrimary end pointSecondary end pointsFirst-line treatmentPhase 2 studySystemic anticancer therapyNew treatment optionsBest overall responseMedian DoRMedian PFSPFS ratesIntolerable toxicity