2025
Tirabrutinib for the treatment of relapsed or refractory primary central nervous system lymphoma: Efficacy and safety from the phase II PROSPECT study.
Nayak L, Grommes C, Kallam A, Peereboom D, Ambady P, Mendez J, Aregawi D, Sumrall A, Omuro A, Iwamoto F, Dietrich J, Umemura Y, Munker R, Chukwueke U, Schaff L, Prados S, Takazawa A, Aoi A, Batchelor T. Tirabrutinib for the treatment of relapsed or refractory primary central nervous system lymphoma: Efficacy and safety from the phase II PROSPECT study. Journal Of Clinical Oncology 2025, 43: 2019-2019. DOI: 10.1200/jco.2025.43.16_suppl.2019.Peer-Reviewed Original ResearchPrimary central nervous system lymphomaTreatment-emergent adverse eventsTreatment-related adverse eventsDuration of responseProgression-free survivalTime to responseMedian duration of responseCentral nervous system lymphomaNervous system lymphomaTyrosine kinase inhibitorsSystem lymphomaOverall survivalResponse rateNeutrophil countProspective studyAdverse eventsTreatment optionsRefractory primary central nervous system lymphomaSecond-generation Bruton's tyrosine kinase inhibitorAggressive form of non-Hodgkin lymphomaOpen-label phase II studyDisease progressionMedian progression-free survivalPhase II prospective studyMedian time to response
2024
TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Loriot Y, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Loriot Y. TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy. Journal Of Clinical Oncology 2024, 42: 3410-3420. PMID: 39186707, PMCID: PMC11458109, DOI: 10.1200/jco.23.01720.Peer-Reviewed Original ResearchConceptsMetastatic urothelial cancerClinical benefit rateProgression-free survivalDuration of responseCisplatin-ineligible patientsCheckpoint inhibitor therapyPhase II studyCheckpoint inhibitorsSacituzumab govitecanCohort 2Central reviewOpen-label phase II studyPlatinum (Pt)-based chemotherapyMedian duration of responseMedian progression-free survivalTreatment-emergent adverse eventsMedian overall survivalSN-38 payloadUrothelial cancer progressionSecondary end pointsAntibody-drug conjugatesCisplatin-ineligibleInhibitor therapyOverall survivalII studySacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer.
Loriot Y, Balar A, Petrylak D, Kalebasty A, Grivas P, Fléchon A, Jain R, Swami U, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zavodovskaya M, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Sacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer. Clinical Cancer Research 2024, 30: 3179-3188. PMID: 39086310, DOI: 10.1158/1078-0432.ccr-23-3924.Peer-Reviewed Original ResearchConceptsTrop-2 expressionTrop-2Positive tumor cellsUrothelial cancerMetastatic UCSacituzumab govitecanTumor cellsTumor samplesOpen-label phase II studyTrophoblast cell surface antigen 2Human trophoblast cell-surface antigen 2Advanced urothelial cancerSN-38 payloadPhase II studyC1-3Archival tumor samplesExpression levelsCohorts 1 to 3Surface antigen 2Antibody drug conjugatesOS benefitII studyExamined tumorsH-scoreMembrane expressionSacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Fléchon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. Journal Of Clinical Oncology 2024, 42: 1415-1425. PMID: 38261969, PMCID: PMC11095901, DOI: 10.1200/jco.22.02835.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based chemotherapyClinical benefit rateProgression-free survivalDuration of responseSacituzumab govitecanCheckpoint inhibitorsCohort 3Central reviewUrothelial cancerFirst-line platinum-based chemotherapyOpen-label phase II studyDay 1Median duration of responseMedian progression-free survivalTreatment-related adverse eventsMedian overall survivalMedian Follow-UpPhase II studySecondary end pointsAntibody-drug conjugatesMetastatic settingOverall survivalStandard therapyII study
2018
Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer
Dickler MN, Saura C, Richards DA, Krop IE, Cervantes A, Bedard PL, Patel MR, Pusztai L, Oliveira M, Cardenas AK, Cui N, Wilson TR, Stout TJ, Wei MC, Hsu JY, Baselga J. Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Cancer. Clinical Cancer Research 2018, 24: 4380-4387. PMID: 29793946, PMCID: PMC6139036, DOI: 10.1158/1078-0432.ccr-18-0613.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsFemaleFulvestrantHumansImidazolesMiddle AgedMutationOxazepinesReceptor, ErbB-2Receptors, EstrogenConceptsAdverse eventsClinical activityBreast cancerMutation statusOpen-label phase II studyHR-positive breast cancerHigher objective response rateConfirmatory phase III trialNCI CTCAE v4.0Median treatment durationObjective response ratePhase II studySerious adverse eventsNew safety signalsPhase III trialsPositive breast cancerClin Cancer ResIntramuscular fulvestrantMeasurable diseaseRECIST v1.1II studyIII trialsPostmenopausal womenUnacceptable toxicityTumor response
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