2020
Final results from the KEYNOTE-100 trial of pembrolizumab in patients with advanced recurrent ovarian cancer.
Matulonis U, Shapira R, Santin A, Lisyanskaya A, Pignata S, Vergote I, Raspagliesi F, Sonke G, Birrer M, Sehouli J, Colombo N, González-Martín A, Oaknin A, Ottevanger P, Rudaitis V, Wu H, Keefe S, Stein K, Ledermann J. Final results from the KEYNOTE-100 trial of pembrolizumab in patients with advanced recurrent ovarian cancer. Journal Of Clinical Oncology 2020, 38: 6005-6005. DOI: 10.1200/jco.2020.38.15_suppl.6005.Peer-Reviewed Original ResearchRecurrent advanced ovarian cancerAdvanced ovarian cancerPD-L1 expressionECOG PS 0Prior chemotherapy linesCohort AChemotherapy linesMedian OSPS 0Ovarian cancerFront-line platinum-based therapyAdvanced recurrent ovarian cancerHigh PD-L1 expressionHigh-grade serous diseaseProtocol-specified final analysisTumor PD-L1 expressionTreatment-related AEsPrimary peritoneal cancerRecurrent ovarian cancerTreatment-free intervalTreatment-related deathsModest antitumor activityModest clinical activityNew safety signalsPrimary study endpointPhase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002)
Santin AD, Deng W, Frumovitz M, Buza N, Bellone S, Huh W, Khleif S, Lankes HA, Ratner ES, O'Cearbhaill RE, Jazaeri AA, Birrer M. Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002). Gynecologic Oncology 2020, 157: 161-166. PMID: 31924334, PMCID: PMC7127981, DOI: 10.1016/j.ygyno.2019.12.034.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsRecurrent cervical cancerPD-L1 expressionPlatinum-based chemotherapyCervical cancerStable diseaseGrade 3 treatment-related adverse eventsGrade 4 treatment-related adverse eventsGrade 5 treatment-related adverse eventsECOG PS 0Prior systemic therapyRecurrent cervical carcinomaResponse/toxicitySingle-agent nivolumabSystemic chemotherapy regimenTolerability of nivolumabImmune checkpoint inhibitorsPercent of patientsAcceptable safety profilePhase II trialKey eligibility criteriaPhase II evaluationECOG PSNivolumab 3RECIST 1.1
2019
Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study
Matulonis UA, Shapira-Frommer R, Santin AD, Lisyanskaya AS, Pignata S, Vergote I, Raspagliesi F, Sonke GS, Birrer M, Provencher DM, Sehouli J, Colombo N, González-Martín A, Oaknin A, Ottevanger PB, Rudaitis V, Katchar K, Wu H, Keefe S, Ruman J, Ledermann JA. Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study. Annals Of Oncology 2019, 30: 1080-1087. PMID: 31046082, DOI: 10.1093/annonc/mdz135.Peer-Reviewed Original ResearchConceptsRecurrent ovarian cancerObjective response rateDisease control rateProgression-free survivalTreatment-free intervalDuration of responseAdvanced recurrent ovarian cancerPD-L1 expressionPlatinum-free intervalCohort AOverall survivalPrior linesCohort BOvarian cancerHigh PD-L1 expressionLow objective response rateMedian DORSolid Tumors version 1.1End pointGynecologic cancer-related deathBlinded independent central reviewSafety of pembrolizumabSingle-agent pembrolizumabMedian overall survivalPhase II study
2018
LBA36 Association of PD-L1 expression and gene expression profiling with clinical response to pembrolizumab in patients with advanced recurrent ovarian cancer: Results from the phase II KEYNOTE-100 study
Ledermann J, Shapira-Frommer R, Santin A, Lisyanskaya A, Pignata S, Vergote I, Raspagliesi F, Sonke G, Birrer M, Provencher D, Sehouli J, Colombo N, González-Martín A, Oaknin A, Ottevanger P, Rudaitis V, Cristescu R, Kobie J, Ruman J, Matulonis U. LBA36 Association of PD-L1 expression and gene expression profiling with clinical response to pembrolizumab in patients with advanced recurrent ovarian cancer: Results from the phase II KEYNOTE-100 study. Annals Of Oncology 2018, 29: viii728. DOI: 10.1093/annonc/mdy424.043.Peer-Reviewed Original ResearchExceptional Response to Pembrolizumab in a Metastatic, Chemotherapy/Radiation-Resistant Ovarian Cancer Patient Harboring a PD-L1-Genetic Rearrangement
Bellone S, Buza N, Choi J, Zammataro L, Gay L, Elvin J, Rimm DL, Liu Y, Ratner E, Schwartz PE, Santin AD. Exceptional Response to Pembrolizumab in a Metastatic, Chemotherapy/Radiation-Resistant Ovarian Cancer Patient Harboring a PD-L1-Genetic Rearrangement. Clinical Cancer Research 2018, 24: 3282-3291. PMID: 29351920, PMCID: PMC6050068, DOI: 10.1158/1078-0432.ccr-17-1805.Peer-Reviewed Original ResearchMeSH KeywordsAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorBiopsyComputational BiologyDrug Resistance, NeoplasmExome SequencingFemaleGene RearrangementHLA AntigensHumansMolecular Targeted TherapyMutationOvarian NeoplasmsPositron Emission Tomography Computed TomographyProgrammed Cell Death 1 ReceptorReceptors, Cell SurfaceRetreatmentT-LymphocytesTreatment OutcomeConceptsImmune checkpoint inhibitor pembrolizumabCheckpoint inhibitor pembrolizumabComplete clinical responseClinical responsePD-L1Ovarian carcinomaAberrant PD-L1 expressionPD-L1 surface expressionAnti-PD1 inhibitorsPD-L1 expressionRemarkable clinical responsesHigh-grade ovarian carcinomaStandard treatment modalityAlternative therapeutic optionClear cell featuresNovel treatment optionsSignificant side effectsT-cell lymphocytesWhole exome sequencing techniqueClin Cancer ResMetastatic human tumorsRecurrent diseaseComplete responseHeavy infiltrationTherapeutic options