2023
Preclinical, randomized phase 1, and compassionate use evaluation of REGN4461, a leptin receptor agonist antibody for leptin deficiency
Altarejos J, Pangilinan J, Podgrabinska S, Akinci B, Foss-Freitas M, Neidert A, Ray Y, Zheng W, Kim S, Kamat V, Huang M, Min S, Mastaitis J, Dominguez-Gutierrez G, Kim J, Stevis P, Huang T, Zambrowicz B, Olson W, Godin S, Bradley E, Gewitz A, Baker M, Hench R, Davenport M, Chenevert T, DiPaola F, Yancopoulos G, Murphy A, Herman G, Musser B, Dansky H, Harp J, Gromada J, Sleeman M, Oral E, Olenchock B. Preclinical, randomized phase 1, and compassionate use evaluation of REGN4461, a leptin receptor agonist antibody for leptin deficiency. Science Translational Medicine 2023, 15: eadd4897. PMID: 37992152, DOI: 10.1126/scitranslmed.add4897.Peer-Reviewed Original ResearchConceptsLeptin concentrationsBody weightHepatic steatosisAdipose-derived hormone leptinClass 3 obesityCompassionate use treatmentHigher baseline leptinLeptin knockout miceAcceptable safety profileLower leptin concentrationsPresence of leptinHuman monoclonal antibodyLeptin receptor signalingTreatment of individualsPhase 1Baseline leptinLepr signalingLeptin deficiencyMetabolic sequelaeLiver diseaseClinical benefitSafety profileInsulin resistanceBlood glucoseInsulin sensitivityDeucravacitinib: A Novel TYK2 Inhibitor for the Treatment of Moderate-to-Severe Psoriasis
Kingston P, Blauvelt A, Strober B, Armstrong A. Deucravacitinib: A Novel TYK2 Inhibitor for the Treatment of Moderate-to-Severe Psoriasis. Journal Of Psoriasis And Psoriatic Arthritis 2023, 8: 156-165. PMID: 38188537, PMCID: PMC10768812, DOI: 10.1177/24755303231201336.Peer-Reviewed Original ResearchSevere plaque psoriasisTreatment of psoriasisPlaque psoriasisMechanism of actionLong-term extension studyNovel oral medicationsOral PDE4 inhibitorPalms/solesAcceptable safety profileHigh-risk patientsTreatment of adultsWeeks of treatmentTreatment of ModeratePivotal clinical studiesType I interferonPASI 75Tuberculosis evaluationSevere psoriasisIL-23Oral medicationsIL-12Blood testsSafety profilePsoriasis pathogenesisTriglyceride levelsA phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1).
Winer I, Patnaik A, Barve M, Kummar S, Schenk E, LoRusso P, Yeku O, Fu S, Jahchan N, Myers M, Liang L, Deegan D, Jackson L, Li Y, Reyno L, Chamberlain M. A phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1). Journal Of Clinical Oncology 2023, 41: 2523-2523. DOI: 10.1200/jco.2023.41.16_suppl.2523.Peer-Reviewed Original ResearchSingle agentDose levelsNon-small cell lung cancerAdvanced refractory solid tumorsDose-escalation study designImmune-related adverse eventsTriple-negative breast cancerImmune checkpoint inhibitorsAcceptable safety profileDose-escalation studyRefractory solid tumorsCell lung cancerArchival tumor tissueEnrollment of subjectsImmune-related reactionsDose proportionalECOG PSRECIST 1.1Stable diseaseTREM1 expressionCheckpoint inhibitorsAdverse eventsPartial responseRadiographic responseGynecologic cancerFirst-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results.
Aggarwal R, Zhang J, Zhu X, Monk P, Jones R, Linch M, Costin D, De Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, Hafeez A, O'Neill V, Tagawa S. First-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results. Journal Of Clinical Oncology 2023, 41: 176-176. DOI: 10.1200/jco.2023.41.6_suppl.176.Peer-Reviewed Original ResearchEvaluable patientsMedian durationDay 1Castration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityImmune-related AEPrime immune cellsAcceptable safety profilePhase 2 studyDurability of responsePlatinum-based chemotherapyImmune effector cellsStandard of careAnti-tumor activityComposite respondersRECIST respondersBID dosingCheckpoint inhibitorsMCRPC patientsPrimary endpointRECIST 1.1Acceptable tolerabilityAdverse eventsCytotoxic chemotherapy
2022
Clinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer.
Tsuji J, Li T, Grinshpun A, Coorens T, Russo D, Anderson L, Rees R, Nardone A, Patterson C, Lennon NJ, Cibulskis C, Leshchiner I, Tayob N, Tolaney SM, Tung N, McDonnell DP, Krop IE, Winer EP, Stewart C, Getz G, Jeselsohn R. Clinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer. Clinical Cancer Research 2022, 28: 5066-5078. PMID: 36215125, PMCID: PMC9722539, DOI: 10.1158/1078-0432.ccr-22-2305.Peer-Reviewed Original ResearchConceptsProgression-free survivalPhase Ib/II studyCombination of palbociclibBreast cancerWhole-exome sequencingESR1 mutationsII studyClinical efficacySafety profileHormone receptor-positive/HER2-negative advanced breast cancerAdvanced hormone receptor-positive breast cancerHER2-negative advanced breast cancerHormone receptor-positive breast cancerThird-generation selective estrogen receptor modulatorMedian progression-free survivalEndocrine-resistant breast cancerReceptor-positive breast cancerShorter progression-free survivalSelective estrogen receptor modulatorsClinical benefit rateAcceptable safety profileAdvanced breast cancerEstrogen receptor modulatorsSelective ER degraderDNA whole-exome sequencingA phase 1b study of glasdegib + azacitidine in patients with untreated acute myeloid leukemia and higher-risk myelodysplastic syndromes
Sekeres MA, Schuster M, Joris M, Krauter J, Maertens J, Breems D, Gyan E, Kovacsovics T, Verma A, Vyas P, Wang ES, Ching K, O’Brien T, Gallo Stampino C, Ma WW, Kudla A, Chan G, Zeidan AM. A phase 1b study of glasdegib + azacitidine in patients with untreated acute myeloid leukemia and higher-risk myelodysplastic syndromes. Annals Of Hematology 2022, 101: 1689-1701. PMID: 35488900, DOI: 10.1007/s00277-022-04853-4.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaHigh-risk myelodysplastic syndromePhase 1b studyChronic myelomonocytic leukemiaMyelodysplastic syndromeExpansion cohortSafety profileMDS cohortMyeloid leukemiaTreatment-emergent adverse eventsUntreated acute myeloid leukemiaNon-hematologic gradeMedian overall survivalAcceptable safety profileOverall response rateDrug-drug interactionsSafety cohortIntensive chemotherapyAdverse eventsOverall survivalClinical benefitQT prolongationAML cohortMyelomonocytic leukemiaGlasdegibBXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of adenocarcinoma phenotype—Phase 2a results.
Zhang J, Aggarwal R, Tagawa S, Linch M, Petrylak D, Costin D, De Bono J, Jones R, Karsh L, Zhu X, Borderies P, Deshpande R, O'Neill V, Monk P. BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of adenocarcinoma phenotype—Phase 2a results. Journal Of Clinical Oncology 2022, 40: 125-125. DOI: 10.1200/jco.2022.40.6_suppl.125.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerAnti-tumor activityEvaluable patientsTaxane chemotherapyPrior linesAndrogen receptorProstate cancerAdenocarcinoma cohortCastration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityBone-only diseaseComposite response rateImmune-related AEPhase 1b/2 studyPrime immune cellsSystemic innate immunityDisease control rateAcceptable safety profileMost prostate cancersAndrogen deprivation treatmentImmune effector cellsCTC conversionMeasurable diseaseRECIST 1.1BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small-cell neuroendocrine carcinoma (SCNC) phenotype—Phase 2a interim results.
Tagawa S, Zhang J, Monk P, Zhu X, Jones R, Linch M, Costin D, De Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, O'Neill V, Aggarwal R. BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small-cell neuroendocrine carcinoma (SCNC) phenotype—Phase 2a interim results. Journal Of Clinical Oncology 2022, 40: 126-126. DOI: 10.1200/jco.2022.40.6_suppl.126.Peer-Reviewed Original ResearchSmall cell neuroendocrine carcinomaMetastatic castration-resistant prostate cancerEvaluable patientsAnti-tumor activityPrior linesCastration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityBone-only diseaseComposite response rateImmune-related AEPhase 1b/2 studyPrime immune cellsSystemic innate immunityAcceptable safety profileImmune effector cellsStandard of careInterim resultsStage 1Prior chemotherapyRECIST 1.1Unconfirmed PRBID dosingCheckpoint inhibitorsMCRPC patients
2021
SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation
Kaplan D, Mehta R, Garcia-Tsao G, Albrecht J, Aytaman A, Baffy G, Bajaj J, Hernaez R, Hunt K, Ioannou G, Johnson K, Kanwal F, Lee T, Monto A, Pandya P, Schaubel D, Taddei T. SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation. Contemporary Clinical Trials 2021, 104: 106367. PMID: 33771685, PMCID: PMC8422958, DOI: 10.1016/j.cct.2021.106367.Peer-Reviewed Original ResearchConceptsHepatic decompensationPortal hypertensionEvents of decompensationHepatic decompensation eventsLiver-related deathSignificant portal hypertensionAcceptable safety profileProspective human studiesRole of statinsChronic liver diseaseClasses of medicationsPatient-reported outcomesDevelopment of decompensationEffect of simvastatinVA Medical CenterCompensated cirrhosisDecompensation eventsStatin therapyVariceal hemorrhageCirrhotic patientsStandard therapyVascular reactivityExert pleiotropic effectsLiver diseaseRetrospective study
2020
Burosumab for the Treatment of Tumor‐Induced Osteomalacia
de Beur S, Miller PD, Weber TJ, Peacock M, Insogna K, Kumar R, Rauch F, Luca D, Cimms T, Roberts MS, San Martin J, Carpenter TO. Burosumab for the Treatment of Tumor‐Induced Osteomalacia. Journal Of Bone And Mineral Research 2020, 36: 627-635. PMID: 33338281, PMCID: PMC8247961, DOI: 10.1002/jbmr.4233.Peer-Reviewed Original ResearchConceptsTumor-induced osteomalaciaCutaneous skeletal hypophosphatemia syndromeSerious adverse eventsAdverse eventsWeek 144Week 48Serum phosphorusTreatment-related adverse eventsFibroblast growth factor 23Surface/bone surfaceAcceptable safety profileOsteoid surface/bone surfacePhase 2 studyGrowth factor 23Phosphaturic mesenchymal tumorTransiliac bone biopsiesHuman monoclonal antibodyMineralization lag timePhosphate metabolismQuality of lifeDose titrationFactor 23Safety profileMesenchymal tumorsSkeletal health359 AMG 757, a half-life extended bispecific T-cell engager (BiTE®) immune therapy against DLL3 in SCLC: phase 1 interim results
Borghaei H, Boyer M, Johnson M, Govindan R, Rodrigues L, Blackhall F, Boosman R, Champiat S, Hummel H, Lai W, Udagawa H, Chiang A, Dowlati A, Hann C, Salgia R, Vokes E, Minocha M, Hashemi-Sadraei N, Shetty A, Smit M, Yang H, Owonikoko T. 359 AMG 757, a half-life extended bispecific T-cell engager (BiTE®) immune therapy against DLL3 in SCLC: phase 1 interim results. Journal For ImmunoTherapy Of Cancer 2020, 8: a384-a384. DOI: 10.1136/jitc-2020-sitc2020.0359.Peer-Reviewed Original ResearchDelta-like ligand 3Small cell lung cancerCytokine release syndromeAdverse eventsImmune therapyPD-1/PD-L1 treatmentDose levelsRefractory small cell lung cancerOngoing phase 1 studiesTreatment-emergent adverse eventsTumor cellsCommon adverse eventsMedian prior linesMedian treatment durationPD-L1 treatmentPlatinum-based regimenAcceptable safety profileDose-proportional increaseFurther dose escalationPhase 1 studyCell lung cancerDuration of responseEthics BoardAnti-tumor activityECOG PSClinical benefit of luspatercept in patients (pts) with lower-risk MDS (LR-MDS) and high transfusion burden in the phase III MEDALIST study.
Zeidan A, Garcia-Manero G, Dezern A, Fenaux P, Greenberg P, Savona M, Jurcic J, Verma A, Mufti G, Buckstein R, Santini V, Laadem A, Zhang J, Rampersad A, Sinsimer D, Louis C, Linde P, List A, Sekeres M. Clinical benefit of luspatercept in patients (pts) with lower-risk MDS (LR-MDS) and high transfusion burden in the phase III MEDALIST study. Journal Of Clinical Oncology 2020, 38: 7554-7554. DOI: 10.1200/jco.2020.38.15_suppl.7554.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsLow-risk MDSRBC transfusion burdenTransfusion burdenRing sideroblastsRBC-TITransfusion eventsClinical benefitWeek 1Significant clinical unmet needPT populationHigh transfusion burdenRBC transfusion independenceRegular RBC transfusionsAcceptable safety profilePhase 3 studyClinical unmet needErythropoiesis-stimulating agentsSerious AEsMedian durationAdverse eventsMedian timeRBC transfusionSafety profileTreatment optionsFirst-in-human phase I study of ARV-110, an androgen receptor (AR) PROTAC degrader in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following enzalutamide (ENZ) and/or abiraterone (ABI).
Petrylak D, Gao X, Vogelzang N, Garfield M, Taylor I, Dougan Moore M, Peck R, Burris H. First-in-human phase I study of ARV-110, an androgen receptor (AR) PROTAC degrader in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following enzalutamide (ENZ) and/or abiraterone (ABI). Journal Of Clinical Oncology 2020, 38: 3500-3500. DOI: 10.1200/jco.2020.38.15_suppl.3500.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerAST/ALTAdverse eventsPSA responseAnti-tumor activityPrior therapyAST/ALT elevationElevated AST/ALTCastrate-resistant prostate cancerProstate cancer xenograft modelPreclinical anti-tumor activityPhase 2 doseRECIST partial responseAcceptable safety profileAcute renal failureHuman phase ICancer xenograft modelPrior chemotherapyALT elevationData cutoffRenal failurePartial responseDose escalationRadium-223Enz resistancePhase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors
Strickler JH, LoRusso P, Salgia R, Kang YK, Yen C, Lin CC, Ansell P, Motwani M, Wong S, Yue H, Wang L, Reilly E, Afar D, Naumovski L, Ramanathan RK. Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2020, 19: 1210-1217. PMID: 32127466, DOI: 10.1158/1535-7163.mct-19-0529.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsStable diseaseDose escalationCommon treatment-related adverse eventsAnti-c-Met antibodyTreatment-related adverse eventsDose-expansion phaseI Dose-EscalationAcceptable safety profileResponse Evaluation CriteriaDose-limiting toxicitySubset of patientsLinear pharmacokinetic profilePeak plasma concentrationAcute infusion reactionsHuman phase IDose cohortsDose expansionRECIST criteriaAdverse eventsEscalation cohortsInfusion reactionsObjective responsePartial responseA First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors
Varga A, Soria JC, Hollebecque A, LoRusso P, Bendell J, Huang SA, Wagle MC, Okrah K, Liu L, Murray E, Sanabria-Bohorquez SM, Tagen M, Dokainish H, Mueller L, Burris H. A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors. Clinical Cancer Research 2020, 26: 1229-1236. PMID: 31848189, DOI: 10.1158/1078-0432.ccr-19-2574.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedDose-Response Relationship, DrugFatigueFemaleHumansMaleMAP Kinase Signaling SystemMaximum Tolerated DoseMiddle AgedMitogen-Activated Protein Kinase 1Mitogen-Activated Protein Kinase 3NauseaNeoplasmsPatient SafetyProtein Kinase InhibitorsPyridonesPyrimidinesTissue DistributionVomitingConceptsBRAF-mutant colorectal cancerColorectal cancerAdverse eventsFDG-PETCommon drug-related adverse eventsSolid tumorsDrug-related adverse eventsPhase IPartial metabolic responseAcceptable safety profileAdvanced solid tumorsDose-proportional increaseGrade 3 rashMetastatic solid tumorsSerial tumor biopsiesSingle-agent activityBest overall responseHuman phase IMAPK pathway inhibitionMultiple tumor typesStable diseaseEscalation studyPartial responseOral inhibitorPharmacodynamic effectsPembrolizumab for Early Triple-Negative Breast Cancer
Schmid P, Cortes J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J. Pembrolizumab for Early Triple-Negative Breast Cancer. New England Journal Of Medicine 2020, 382: 810-821. PMID: 32101663, DOI: 10.1056/nejmoa1910549.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCyclophosphamideDoxorubicinEpirubicinFemaleHumansIntention to Treat AnalysisKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyNeoplasm StagingPaclitaxelTriple Negative Breast NeoplasmsConceptsEarly triple-negative breast cancerTriple-negative breast cancerPathological complete responseCycles of pembrolizumabPercentage of patientsDefinitive surgeryComplete responseBreast cancerNeoadjuvant chemotherapyTreatment-related adverse eventsUntreated stage IIPrimary end pointAcceptable safety profileEvent-free survivalPhase 3 trialSecond primary tumorsFirst interim analysisAdjuvant pembrolizumabTreat populationDistant recurrenceNeoadjuvant therapyPromising antitumor activityAdverse eventsSafety profilePrimary tumorFORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression.
Quinn D, Petrylak D, Bellmunt J, Necchi A, Gurney H, Lee J, Van Der Heijden M, Rosenbaum E, Penel N, Pang S, Li J, Garcia del Muro X, Joly F, Papai Z, Ellinghaus P, Lu C, Nakajima K, Ishida T, Nishiyama H, Sternberg C. FORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression. Journal Of Clinical Oncology 2020, 38: 489-489. DOI: 10.1200/jco.2020.38.6_suppl.489.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaUrothelial carcinomaPhase II/III studyMedian progression-free survivalTreatment-emergent adverse eventsMuscle-invasive urothelial carcinomaPhase II/IIIDisease control rateOpen-label studyProgression-free survivalStage IV diseaseAcceptable safety profileUrinary tract infectionDNA alterationsStage IIIBIII studyPrior immunotherapyStandard chemotherapyTract infectionsAdverse eventsMedian agePlatinum chemotherapySafety profileControl rateSubgroup analysisPhase 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
A Phase Ia/Ib Study Exploring the Synthetic Lethality of the Orally Administered Novel BTK Inhibitor, Dtrmwxhs-12 (DTRM-12), in Combination with Everolimus and Pomalidomide in Patients with Relapsed/Refractory CLL, DLBCL or Other B-Cell Lymphomas
Mato A, Schuster S, Foss F, Isufi I, Ding W, Brander D, Sitlinger A, Tun H, Moustafa M, Kennard K, King C, Koehler A, Aitken C, He W, Kearney A, Gui M, Anderson B, Rosenthal A, Roeker L, Huntington S. A Phase Ia/Ib Study Exploring the Synthetic Lethality of the Orally Administered Novel BTK Inhibitor, Dtrmwxhs-12 (DTRM-12), in Combination with Everolimus and Pomalidomide in Patients with Relapsed/Refractory CLL, DLBCL or Other B-Cell Lymphomas. Blood 2019, 134: 810. DOI: 10.1182/blood-2019-126192.Peer-Reviewed Original ResearchChronic lymphocytic leukemiaB-cell lymphomaHodgkin's lymphomaRichter transformationCombination therapyCell lymphomaPrimary endpointRelapsed/Refractory Chronic Lymphocytic LeukemiaDose reduction/interruptionDose-limiting toxicity periodLow-dose combination therapyMedian age 70 yearsR CLLRefractory chronic lymphocytic leukemiaHigh unmet medical needPhase IMedian prior therapiesReduction/interruptionTriplet combination therapyUS multicenter studyAcceptable safety profileProgression-free survivalDaily oral administrationDurability of responseAge 70 years350P Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173)
Wesolowski R, Brufsky A, Chambers M, Bhattacharya S, Lustberg M, VanDeusen J, Sardesai S, Williams N, Noonan A, Phelps M, Grever M, Stephens J, Carson W, Ramaswamy B. 350P Phase Ib study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173). Annals Of Oncology 2019, 30: v126. DOI: 10.1093/annonc/mdz242.045.Peer-Reviewed Original ResearchTriple-negative breast cancerOverall response rateNegative breast cancerBreast cancerDay 1Cancer Therapy Evaluation ProgramCycle 1Clinical benefit rateCommon grade 3Dose level 1Dose-expansion studyHigher adverse eventsPhase Ib studySchedule of paclitaxelAcceptable safety profileProgression-free survivalHeat shock protein 90 inhibitorShock protein 90 inhibitorsNational Cancer InstituteEvaluable ptsPaclitaxel hypersensitivityStudy regimenAdverse eventsMethods PatientsSafety profile
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