2020
Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119.
Winer E, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Schmid P, Testa L, Witzel I, Ohtani S, Lunceford J, Karantza V, Mejia J, Cristescu R, Aurora-Garg D, Jelinic P, Huang L, Cortes J. Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119. Journal Of Clinical Oncology 2020, 38: 1013-1013. DOI: 10.1200/jco.2020.38.15_suppl.1013.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTumor mutational burdenMut/MbClinical outcomesTriple-negative breast cancerChemo-treated patientsPrior systemic treatmentThird-line settingOverall study populationNumber of patientsTwo-sided p valuePD-L1 enrichmentReceiver operator characteristic analysisEstimates of efficacyOperator characteristic analysisP-valueFoundationOne CDxBaseline characteristicsMetastatic diseaseSystemic treatmentPotential positive associationTreatment armsClinical benefitCox regressionBreast cancerPrevalence and mutational determinants of high tumor mutation burden in breast cancer
Barroso-Sousa R, Jain E, Cohen O, Kim D, Buendia-Buendia J, Winer E, Lin N, Tolaney S, Wagle N. Prevalence and mutational determinants of high tumor mutation burden in breast cancer. Annals Of Oncology 2020, 31: 387-394. PMID: 32067680, DOI: 10.1016/j.annonc.2019.11.010.Peer-Reviewed Original ResearchConceptsHigh tumor mutation burdenTumor mutation burdenPD-1 inhibitorsBreast cancerMutation burdenMedian tumor mutation burdenDifferent mutational signaturesPembrolizumab-based therapyMetastatic breast cancerSubset of patientsMut/MbMismatch repair deficiencyGenomic profilesMutational patternsAPOBEC activityGene panel sequencingMultiple tumor typesWhole-exome sequencingDe-identified dataDurable responsesMetastatic tumorsPrimary tumorTumor subtypesPatientsTumor types
2019
Nimbus: A phase II study of nivolumab plus ipilimumab in metastatic hypermutated HER2-negative breast cancer.
Barroso-Sousa R, Trippa L, Lange P, Andrews C, McArthur H, Haley B, Rugo H, Emens L, Winer E, Mittendorf E, Tolaney S. Nimbus: A phase II study of nivolumab plus ipilimumab in metastatic hypermutated HER2-negative breast cancer. Journal Of Clinical Oncology 2019, 37: tps1115-tps1115. DOI: 10.1200/jco.2019.37.15_suppl.tps1115.Peer-Reviewed Original ResearchMetastatic breast cancerTumor mutational burdenHER2-negative breast cancerBreast cancerResponse rateObjective responseTrue response rateMetastatic HER2-negative breast cancerHER2-negative metastatic breast cancerFurther studiesCombination of nivolumabEfficacy of nivolumabPhase 2 studyPhase II studyProgression-free survivalOverall response rateMut/MbMutations/megabaseCancer gene panelRECIST 1.1II studyOverall survivalPrior linesPeripheral bloodDisease progression