2025
Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study.
Medina T, Chesney J, Kluger H, Hamid O, Whitman E, Cusnir M, Thomas S, Wermke M, Domingo-Musibay E, Phan G, Kirkwood J, Larkin J, Weber J, Finckenstein F, Chou J, Gastman B, Sulur G, Wu R, Fiaz R, Sarnaik A. Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study. Journal Of Clinical Oncology 2025, 43: 9515-9515. DOI: 10.1200/jco.2025.43.16_suppl.9515.Peer-Reviewed Original ResearchDuration of responseAnti-PD-1/PD-L1 therapyAdvanced melanomaFollow-upOverall survivalEastern Cooperative Oncology Group performance statusAnti-PD-1/PD-L1Autologous T-cell immunotherapyMedian duration of responseTreatment-emergent adverse eventsDoses of interleukin-2Treatment of adult patientsImmune checkpoint inhibitorsT-cell immunotherapyTumor-infiltrating lymphocytesDurability of responseLong-term safety concernsOpen-label studyStudy follow-upGroup of ptsMedian OSRefractory melanomaCheckpoint inhibitorsOS ratesRECIST v1.1
2024
Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS)
Komrokji R, Diez-Campelo M, Chee L, Cluzeau T, DeZern A, Fenaux P, Garcia-Manero G, Giagounidis A, Platzbecker U, Della Porta M, Santini V, Sekeres M, Zeidan A, Buckstein R, Ross M, Jiang Y, Bobba S, Hankin M, Materna C, Graham C, Thamake S, Rovaldi C, Grayson D, Salstrom J. Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS). Blood 2024, 144: 3228.1-3228.1. DOI: 10.1182/blood-2024-200797.Peer-Reviewed Original ResearchDurability of responseMyelodysplastic neoplasmsFollow-up periodTransfusion burdenProportion of participantsAdverse eventsTransfusion independenceIneffective hematopoiesisDouble-blindPlacebo-controlled phase 3 studyAchievement of transfusion independenceMultiple stages of hematopoiesisSafety follow-up periodDouble-blind treatment periodLong-term follow-up periodSeverity of adverse eventsLong-term follow-upErythroid maturation agentLow transfusion burdenSustained hematologic improvementTreatment of transfusion-dependent anemiaPlacebo-controlled studyTransfusion-dependent anemiaPhase 3 studyProgression to AMLEFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC FOR PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER: 36-MONTH FOLLOW-UP FROM A PHASE 3 TRIAL
Boorjian S, Narayan V, Master V, Konety B, Shore N, Kamat A, Dinney C, Bivalacqua T, Kates M, Montgomery J, Lerner S, Crispen P, Steinberg G, Agarwal P, Schuckman A, Svatek R, Lane B, Karsh L, Bjurlin M, Brown G, Lotan Y, Inman B, Williams M, Cookson M, Chang S, Kim E, Sankin A, O'Donnell M, Jakobsen J, Juul K. EFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC FOR PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER: 36-MONTH FOLLOW-UP FROM A PHASE 3 TRIAL. Urologic Oncology Seminars And Original Investigations 2024, 42: s70. DOI: 10.1016/j.urolonc.2024.01.201.Peer-Reviewed Original ResearchBCG-unresponsive NMIBCNon-muscle invasive bladder cancerPhase 3 studyFollow-up resultsNadofaragene firadenovecCarcinoma in situPapillary diseaseTreatment optionsFollow-upProgression to muscle-invasive diseaseDiscontinuation due to adverse eventsOpen-label phase 3 studyVector-based gene therapyTreatment of adult patientsBenefit-to-risk ratioDuration of follow-upCystectomy-free survivalHigh-grade recurrenceMuscle-invasive diseaseDurability of responseDuration of CRInvasive bladder cancerMonths of treatmentNovel treatment optionsBCG-unresponsive
2023
A Phase I Study of Asciminib (ABL001) in Combination with Dasatinib and Prednisone for BCR-ABL1-Positive ALL and Blast Phase CML in Adults
Luskin M, Murakami M, Keating J, Winer E, Garcia J, Stahl M, Wadleigh M, Flamand Y, Neuberg D, Galinsky I, Leonard R, Hagopian E, Weizer C, McLanahan C, Stone R, Wang E, Stock W, DeAngelo D. A Phase I Study of Asciminib (ABL001) in Combination with Dasatinib and Prednisone for BCR-ABL1-Positive ALL and Blast Phase CML in Adults. Blood 2023, 142: 965. DOI: 10.1182/blood-2023-174246.Peer-Reviewed Original ResearchAcute lymphoblastic leukemiaDose-limiting toxicityMaximum tolerated doseStem cell transplantationPhase I studyCML-LBCDose escalationAllogeneic stem cell transplantationBCR-ABL1-positive acute lymphoblastic leukemiaCell line xenograft modelsPatient-derived xenograft modelsBlast phase CMLEscalating daily dosesPhase 2 doseLymphoid blast crisisBiomarkers of responseDurability of responseChronic myeloid leukemiaABL1 inhibitorsDose expansionEscalating dosesBlast crisisDeep remissionExpansion cohortTolerated doseFirst-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
Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆
Balar A, Castellano D, Grivas P, Vaughn D, Powles T, Vuky J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Necchi A, Petrylak D, Plimack E, Xu J, Imai K, Moreno B, Bellmunt J, de Wit R, O’Donnell P. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆. Annals Of Oncology 2022, 34: 289-299. PMID: 36494006, DOI: 10.1016/j.annonc.2022.11.012.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaBlinded independent central reviewCisplatin-ineligible patientsObjective response rateRECIST version 1.1Years of followUrothelial carcinomaKEYNOTE-045KEYNOTE-052Primary endpointMost treatment-related adverse eventsResponse rateSurvival rateConfirmed objective response rateTreatment-related adverse eventsProgression-free survival ratesFurther safety concernsPlatinum-containing chemotherapyFirst-line therapyImmune checkpoint inhibitorsNew safety signalsProgression-free survivalDurability of responseFirst-line pembrolizumabOverall survival rateOne-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial
Strober B, Stein Gold L, Bissonnette R, Armstrong A, Kircik L, Tyring S, Piscitelli S, Brown P, Rubenstein D, Tallman A, Lebwohl M. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial. Journal Of The American Academy Of Dermatology 2022, 87: 800-806. PMID: 35772599, DOI: 10.1016/j.jaad.2022.06.1171.Peer-Reviewed Original ResearchConceptsOpen-label treatmentRemittive effectsPlaque psoriasisUpper respiratory tract infectionPhysician Global Assessment scoreComplete disease clearanceOne-year safetyFrequent adverse eventsSevere plaque psoriasisNew safety signalsPhase 3 trialRespiratory tract infectionsDurability of responseForms of psoriasisGlobal assessment scoreLong-term safetyEligible patientsTapinarof creamDisease clearanceAdverse eventsTract infectionsMean durationSafety signalsContact dermatitisCream 1AB0227 TREATMENT SEQUENCING PATTERNS AND COMPARATIVE EFFICACY IN PATIENTS WITH RHEUMATOID ARTHRITIS FROM A REAL-WORLD SETTING
Ai L, Higashi M, Lee K, Liu Z, Jin L, Raja K, Mai Y, Jun T, Oh W, Beckmann A, Schadt E, Schadt Z, Wallsten R, Calay E, Kasarskis A, Pan Q, Schadt E, Wang X. AB0227 TREATMENT SEQUENCING PATTERNS AND COMPARATIVE EFFICACY IN PATIENTS WITH RHEUMATOID ARTHRITIS FROM A REAL-WORLD SETTING. Annals Of The Rheumatic Diseases 2022, 81: 1241. DOI: 10.1136/annrheumdis-2022-eular.4655.Peer-Reviewed Original ResearchDisease-modifying antirheumatic drugsTime to next treatmentConventional synthetic DMARDsDurability of responseRheumatoid arthritisElectronic health recordsAntirheumatic drugsImproved duration of responseConventional synthetic disease-modifying antirheumatic drugsBiologic disease-modifying antirheumatic drugsSynthetic disease-modifying antirheumatic drugsPredictors of disease progressionSecond-line settingSecond-line therapyDuration of responseLines of therapyEuropean League Against RheumatismTime-to-event analysisMethods Electronic health recordsManagement of rheumatoid arthritisCsDMARD combinationSecond-lineAnti-TNFTNFi therapyImprove patient outcomes
2021
Venetoclax for the treatment of elderly or chemotherapy-ineligible patients with acute myeloid leukemia: a step in the right direction or a game changer?
Agarwal S, Kowalski A, Schiffer M, Zhao J, Bewersdorf JP, Zeidan AM. Venetoclax for the treatment of elderly or chemotherapy-ineligible patients with acute myeloid leukemia: a step in the right direction or a game changer? Expert Review Of Hematology 2021, 14: 199-210. PMID: 33459064, DOI: 10.1080/17474086.2021.1876559.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaIntensive chemotherapyAML patientsTherapeutic optionsMyeloid leukemiaComposite complete remission rateOral BCL-2 inhibitorChemotherapy-ineligible patientsNovel triplet combinationLow-dose cytarabineComplete remission rateDurability of responseAttractive therapeutic optionPubMed/MEDLINERemission rateElderly patientsTreatment landscapeAML treatmentPoor prognosisAggressive malignancyCombination therapyBcl-2 inhibitorsMechanisms of resistanceClinical dataToxicity profile
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 years
2017
Durability of the Rituximab Response in Acetylcholine Receptor Autoantibody–Positive Myasthenia Gravis
Robeson KR, Kumar A, Keung B, DiCapua DB, Grodinsky E, Patwa HS, Stathopoulos PA, Goldstein JM, O’Connor K, Nowak RJ. Durability of the Rituximab Response in Acetylcholine Receptor Autoantibody–Positive Myasthenia Gravis. JAMA Neurology 2017, 74: 60-66. PMID: 27893014, DOI: 10.1001/jamaneurol.2016.4190.Peer-Reviewed Original ResearchConceptsDurability of responseMyasthenia gravisRituximab treatmentAnti-AChR antibody levelsB cell-targeted therapiesLong-term clinical responseRetrospective case series studyTreatment of MGEvidence-based practice parametersLast rituximab treatmentRefractory myasthenia gravisSerum cytokine levelsComplete stable remissionSubset of patientsCase series studyMyasthenia Gravis FoundationMG clinicPharmacologic remissionRituximab cyclesSustained remissionAutoantibody levelsInflammatory markersRituximab therapyClinical improvementClinical response
2012
Targeted approaches to the treatment of pulmonary hypertension
Fares WH, Trow TK. Targeted approaches to the treatment of pulmonary hypertension. Therapeutic Advances In Respiratory Disease 2012, 6: 147-159. PMID: 22438264, DOI: 10.1177/1753465812441849.Peer-Reviewed Original ResearchConceptsPulmonary arterial hypertensionArterial hypertensionHigh-dose calcium channel blockersChest Physicians criteriaMultiple therapeutic optionsDurability of responseCalcium channel blockersTransplant evaluationPulmonary hypertensionOral therapyClose followPhysician's criteriaTherapeutic optionsChannel blockersEarly initiationAmerican CollegeHigh riskPatientsIncurable diseaseHypertensionEarly useStatus benefitsTreatmentDiseaseProgression
2011
Limb Preservation With Isolated Limb Infusion for Locally Advanced Nonmelanoma Cutaneous and Soft-Tissue Malignant Neoplasms
Turaga K, Beasley G, Kane J, Delman K, Grobmyer S, Gonzalez R, Letson G, Cheong D, Tyler D, Zager J. Limb Preservation With Isolated Limb Infusion for Locally Advanced Nonmelanoma Cutaneous and Soft-Tissue Malignant Neoplasms. JAMA Surgery 2011, 146: 870-875. PMID: 21768436, PMCID: PMC4515974, DOI: 10.1001/archsurg.2011.139.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticAntineoplastic Agents, AlkylatingBiomarkers, TumorCarcinoma, Merkel CellCarcinoma, Squamous CellChemotherapy, Cancer, Regional PerfusionCreatine KinaseDactinomycinDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFollow-Up StudiesHumansLength of StayLimb SalvageMaleMelphalanMiddle AgedRetrospective StudiesSarcomaSkin NeoplasmsSoft Tissue NeoplasmsTreatment OutcomeYoung AdultConceptsSoft tissue malignant neoplasmIn-field response rateSerum creatinine phosphokinase levelsIsolated limb infusionCreatinine phosphokinase levelsSoft tissue sarcomasMalignant neoplasmsLimb preservationCell carcinomaResponse rateEfficacy of isolated limb infusionLocally advanced soft tissue sarcomasAdvanced soft tissue sarcomaShort-term response rateGrade IV toxicityResection of diseaseDurability of responseMedian Follow-UpMerkel cell carcinomaRegional disease controlMedian length of staySquamous cell carcinomaCutaneous malignant neoplasmsLimb preservation ratesSignificant treatment challenge
2004
TLR9 Agonist Immunomodulator Treatment of Cutaneous T-Cell Lymphoma (CTCL) with CPG7909.
Kim Y, Girardi M, Duvic M, Kuzel T, Rook A, Link B, Pinter-Brown L, Comerci C, McAuley S, Schmalbach T. TLR9 Agonist Immunomodulator Treatment of Cutaneous T-Cell Lymphoma (CTCL) with CPG7909. Blood 2004, 104: 743. DOI: 10.1182/blood.v104.11.743.743.Peer-Reviewed Original ResearchCutaneous T-cell lymphomaCPG 7909Progressive diseaseClinical responseStable diseasePartial responseComplete responseAdvanced cutaneous T-cell lymphomaModerate flu-like symptomsGlobal assessmentLocal injection site reactionsCTC grade 1More systemic therapiesObjective clinical responsesPhysician global assessmentDurability of responseFlu-like symptomsInjection site reactionsNK cell functionPhase II portionWeeks of treatmentResults of patientsT-cell lymphomaGamma-glutamyl transferaseImmunomodulator treatment
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