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 v1.1Should we treat TP53-mutated high-risk myeloid neoplasms in older patients?
Badar T, E.l. Kettani M, Shah K, Jamy O, Shallis R, Diebold K, Coltoff A, Goldberg A, Patel A, Bewersdorf J, Foucar C, Abaza Y, Palmisiano N, DuVall A, Kota V, Zeidan A, Atallah E, Litzow M. Should we treat TP53-mutated high-risk myeloid neoplasms in older patients? Journal Of Clinical Oncology 2025, 43: 6538-6538. DOI: 10.1200/jco.2025.43.16_suppl.6538.Peer-Reviewed Original ResearchMedian overall survivalHigh-risk myeloid neoplasmsAllo-HCTDuration of responseTP53-MTHypomethylating agentsVariant allele frequencyOlder ptsMyeloid neoplasmsECOG-PSHR-MDSEastern Cooperative Oncology Group performance statusMedian duration of responseTP53 variant allele frequencyAllogeneic stem cell transplantationECOG-PS 0De novo AMLLong-term remissionStem cell transplantationLow-intensity therapyMulticenter observational studyProportion of ptsDisease-directed therapyMulti-center studyMPN-BPDeterminants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry
Cortellini A, Brunetti L, Di Fazio G, Garbo E, Pinato D, Naidoo J, Katz A, Loza M, Neal J, Genova C, Gettinger S, Kim S, Jayakrishnan R, Zarif T, Russano M, Pecci F, Di Federico A, Awad M, Alessi J, Montrone M, Owen D, Signorelli D, Fidler M, Li M, Camerini A, De Giglio A, Young L, Vincenzi B, Metro G, Passiglia F, Yendamuri S, Guida A, Ghidini M, Awosika N, Napolitano A, Fulgenzi C, Grisanti S, Grossi F, D’Incecco A, Josephides E, Van Hemelrijck M, Russo A, Gelibter A, Spinelli G, Verrico M, Tomasik B, Giusti R, Newsom-Davis T, Bria E, Sebastian M, Rost M, Forster M, Mukherjee U, Landi L, Mazzoni F, Aujayeb A, Dupont M, Curioni-Fontecedro A, Chiari R, Pantano F, Morabito A, Leonetti A, Friedlaender A, Addeo A, Zoratto F, De Tursi M, Cantini L, Roca E, Mountzios G, Della Gravara L, Kalvapudi S, Inno A, Bironzo P, Di Marco Barros R, O’Reilly D, Bell J, Karapanagiotou E, Monnet I, Baena J, Macerelli M, Majem M, Agustoni F, Cortinovis D, Tonini G, Minuti G, Bennati C, Mezquita L, Gorría T, Servetto A, Beninato T, Russo G, Rogado J, Moliner L, Biello F, Nana F, Dingemans A, Aerts J, Ferrara R, Torri V, Abu Hejleh T, Takada K, Naqash A, Garassino M, Peters S, Wakelee H, Nassar A, Ricciuti B. Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: results from the Pembro-real 5Y global registry. Journal For ImmunoTherapy Of Cancer 2025, 13: e010674. PMID: 39904562, PMCID: PMC11795382, DOI: 10.1136/jitc-2024-010674.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerProgrammed cell death ligand 1Eastern Cooperative Oncology Group performance statusData cut-offLong-term efficacyIndividual patient-level dataMedian OSPembrolizumab monotherapySurvival rateProgressive diseaseDiscontinued treatment due to progressive diseaseTreated with first-line pembrolizumabClinical trialsPredictors of 5-year survivalFirst-line pembrolizumab monotherapyCell death ligand 1Pre-existing autoimmune diseaseFirst-line pembrolizumabKEYNOTE-024 trialPD-L1 TPSPermanently discontinue treatmentDeath-ligand 1Efficacy of pembrolizumabMedian follow-upTransarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim J, Zhao H, Li C, Madoff D, Ghobrial R, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry A, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel A, Finn R, Llovet J, investigators L. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. The Lancet 2025, 405: 203-215. PMID: 39798578, DOI: 10.1016/s0140-6736(24)02575-3.Peer-Reviewed Original ResearchConceptsEastern Cooperative Oncology GroupNon-metastatic hepatocellular carcinomaProgression-free survivalTreatment-related adverse eventsPembrolizumab groupPhase 3 studyTransarterial chemoembolisationPlacebo groupHepatocellular carcinomaIntention-to-treatOverall survivalDouble-blindPerformance statusAdverse eventsFollow-upEastern Cooperative Oncology Group performance statusChild-Pugh class A diseaseMedian progression-free survivalSolid Tumors version 1.1Blinded independent central reviewA-fetoprotein levelAlbumin-bilirubin gradeResponse Evaluation CriteriaAs-treated populationMedian follow-up
2024
Isatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702)
Parker T, Rosenthal A, Sanchorawala V, Landau H, Campagnaro E, Kapoor P, Neparidze N, Girnius S, Hagen P, Scott E, Hoering A, Durie B, Orlowski R. Isatuximab in Relapsed AL Amyloidosis: Results of a Prospective Phase II Trial (SWOG S1702). Blood 2024, 144: 3378-3378. DOI: 10.1182/blood-2024-208341.Peer-Reviewed Original ResearchMedian time to responseRelapsed AL amyloidosisTime to responseAL amyloidosisPartial responseHematologic responseComplete responseCardiac involvementOverall survivalRenal involvementOrgan involvementEastern Cooperative Oncology Group performance statusRate of hematologic responseAutologous stem cell transplantationProspective phase II trialLight chain (AL) amyloidosisDistribution of organ involvementProgression free survivalHematologic complete responseHematologic response rateStem cell transplantationPhase II trialAnti-CD38 antibodiesSystemic AL amyloidosisRate of patientsPhase 1 Study of ARV-393, a PROTAC BCL6 Degrader, in Advanced Non-Hodgkin Lymphoma
Caimi P, Huntington S, Landrette S, Gough S, Dai V, Jackson B, Yu T, Chavez J, Tannenbaum-Dvir S, Matasar M. Phase 1 Study of ARV-393, a PROTAC BCL6 Degrader, in Advanced Non-Hodgkin Lymphoma. Blood 2024, 144: 6505. DOI: 10.1182/blood-2024-208356.Peer-Reviewed Original ResearchNon-Hodgkin's lymphomaB-cell non-Hodgkin lymphomaDiffuse large B-cell lymphomaStem cell transplantationPhase 1 studyCell transplantationAdvanced B-cell non-Hodgkin's lymphomaB cellsMature B-cell non-Hodgkin lymphomaXenograft models of non-Hodgkin lymphomaBCL6 expressionEastern Cooperative Oncology Group performance statusModel of non-Hodgkin lymphomaAdvanced non-Hodgkin's lymphomaAllogeneic stem cell transplantationAngioimmunoblastic T-cell lymphomaAutologous stem cell transplantationLarge B-cell lymphomaNon-Hodgkin's lymphoma casesCell line-derived xenograft modelT follicular helper cellsPatient-derived xenograft modelsStandard of care therapyHigh risk of transformationCentral nervous system involvementReal-World Efficacy and Patient-Reported Quality of Life Outcomes with Daratumumab Regimens in Multiple Myeloma
Browning S, Li F, Theprungsirikul P, Parker T, Bar N, Giri S, Anderson T, Stevens E, Gorshein E, Sabbath K, Wei C, Ali S, Witt D, Persico J, Talsania A, Rahmat L, Kidwai W, Legare R, LaSala J, Austin M, Neparidze N. Real-World Efficacy and Patient-Reported Quality of Life Outcomes with Daratumumab Regimens in Multiple Myeloma. Blood 2024, 144: 7831. DOI: 10.1182/blood-2024-204150.Peer-Reviewed Original ResearchRelapsed/refractory multiple myelomaInternational Myeloma Working GroupAdverse eventsGlobal health statusFunctional scalesMultiple symptom scalesPartial responseProteasome inhibitorsMultiple myelomaHealth statusEastern Cooperative Oncology Group performance statusClinical trialsMonoclonal antibody targeting CD38Median progression free survivalRelapsed/refractory multiple myeloma patientsIntroduction of novel therapiesHealth-related quality of lifeClinical response assessmentDaratumumab-based regimensProgression free survivalInfusion-related reactionsLines of therapyPatient-reported quality of life outcomesMean fatigue scoreHealth-related qualityPembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial
Dzienis M, Cundom J, Fuentes C, Spreafico A, Nordlinger M, Pastor A, Alesi E, Neki A, Fung A, Lima I, Oppelt P, da Cunha G, Burtness B, Franke F, Tseng J, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. Journal Of Clinical Oncology 2024, 42: 2989-2999. PMID: 39038265, PMCID: PMC11361359, DOI: 10.1200/jco.23.02625.Peer-Reviewed Original ResearchBlinded independent central reviewRecurrent/metastatic head and neck squamous cell carcinomaHead and neck squamous cell carcinomaNeck squamous cell carcinomaR/M HNSCCSquamous cell carcinomaRECIST v1.1Cell carcinomaSingle-armStandard-of-care first-line treatmentSafety of first-line pembrolizumabEastern Cooperative Oncology Group performance statusDay 1Treatment-related adverse eventsAlternative chemotherapy combinationsFirst-line pembrolizumabPD-L1 statusMedian follow-upFirst-line therapyIndependent central reviewFirst-line treatmentPhase IV trialChemotherapy combinationsComplete responsePD-L1Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial
Fehm T, Cottone F, Dunton K, André F, Krop I, Park Y, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego M, Yerushalmi R, Duhoux F, Takano T, Lu W, Egorov A, Kim S. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. The Lancet Oncology 2024, 25: 614-625. PMID: 38697155, DOI: 10.1016/s1470-2045(24)00128-1.Peer-Reviewed Original ResearchConceptsTreatment of physician's choiceMetastatic breast cancerTreatment of physician's choice groupPatient-reported outcomesPhysician's choice groupTrastuzumab deruxtecan groupTrastuzumab deruxtecanPhase 3 trialHER2-positiveBreast cancerGlobal health statusPhysician's choiceEORTC QLQ-C30 global health statusPatient-reported outcome variablesOpen-labelQLQ-C30 global health statusTrastuzumab emtansineDefinitive deteriorationMedian time to definitive deteriorationHER2-positive metastatic breast cancerEastern Cooperative Oncology Group performance statusTreatment durationBlinded independent central reviewQuality of lifeProgression-free survival
2023
A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
DiNardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Frankel S, Weiss D, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. Blood 2023, 142: 1548. DOI: 10.1182/blood-2023-186036.Peer-Reviewed Original ResearchR AMLAcute myeloid leukemiaRefractory acute myeloid leukemiaCell line-derived xenograftsDose-escalation studyMyelodysplastic syndromeCentral nervous systemDose levelsEscalation studyFirst doseTreatment armsMyeloid leukemiaEastern Cooperative Oncology Group performance statusRelapsed/Refractory Acute Myeloid LeukemiaPatient-derived xenograft AML modelHigh-risk myelodysplastic syndromeHigh unmet medical needAnimal models representativeMultiple prior linesPhase 2 doseSingle-patient cohortsTreatment arm ATreatment arm B.Antitumor activitySingle-dose pharmacokineticsOutcomes of Patients Receiving Intensive Therapy for Acute Myeloid Leukemia Relapsed after/Refractory to Frontline Less-Intensive Therapy
Achar R, McCormick B, Dworkin E, Geramita E, Im A, Patel A, Badar T, Shallis R. Outcomes of Patients Receiving Intensive Therapy for Acute Myeloid Leukemia Relapsed after/Refractory to Frontline Less-Intensive Therapy. Blood 2023, 142: 5859. DOI: 10.1182/blood-2023-179336.Peer-Reviewed Original ResearchOverall response rateAcute myeloid leukemiaMedian overall survivalMajority of ptsIntensive induction therapyIntensive therapyOverall survivalComplete remissionFrontline therapyR therapyInduction chemotherapyInduction therapyCPX-351Eastern Cooperative Oncology Group performance statusExact testResponse rateMorphologic leukemia-free stateR AMLRelapsed/refractory (R/R) diseaseHematopoietic stem cell transplantationCox proportional hazards modelContinuous variablesAdverse-risk diseaseIncomplete count recoveryIntensive induction chemotherapyReal-World Utilization of Daratumumab in Front-Line Treatment of Newly Diagnosed Multiple Myeloma: A Retrospective Observational Study
Theprungsirikul P, Liu Y, Neparidze N. Real-World Utilization of Daratumumab in Front-Line Treatment of Newly Diagnosed Multiple Myeloma: A Retrospective Observational Study. Blood 2023, 142: 7364. DOI: 10.1182/blood-2023-186985.Peer-Reviewed Original ResearchFront-line treatmentBone marrow plasma cellsCommunity practice settingsR-ISS stageECOG performance statusRetrospective observational studyPerformance statusTransplant eligibilityPractice settingsCytogenetic abnormalitiesBone lesionsInsurance typeObservational studyTreatment responseEastern Cooperative Oncology Group performance statusInternational Myeloma Working Group criteriaYale New Haven Health SystemInternational Staging System stageRefractory multiple myeloma patientsUnfavorable-risk cytogeneticsGood partial responseFront-line therapyCD38 monoclonal antibodyMultiple myeloma patientsBetter treatment responseSafety and Preliminary Efficacy of DFV890 in Adult Patients with Myeloid Diseases: A Phase 1b Study
Garcia-Manero G, Ooi M, Lao Z, Gill H, Abaza Y, Stahl M, Haque T, DeZern A, Greenberg P, Pelletier M, Singh A, Carreon D, Beaulieu V, Woo J. Safety and Preliminary Efficacy of DFV890 in Adult Patients with Myeloid Diseases: A Phase 1b Study. Blood 2023, 142: 3250. DOI: 10.1182/blood-2023-174642.Peer-Reviewed Original ResearchChronic myelomonocytic leukemiaCMML-specific prognostic scoring systemErythropoiesis-stimulating agentsDose-expansion partPrognostic Scoring SystemMyelodysplastic syndromeHypomethylating agentsLR-MDSEastern Cooperative Oncology Group performance statusIntermediate risk myelodysplastic syndromePredictive markers of efficacyDose of study treatmentInternational Prognostic Scoring SystemIL-18Colony-stimulating growth factorScoring systemAllogeneic hematopoietic transplantationBone marrow aspirate/biopsyPhase 1b studyProgression-free survivalTime to progressionPotential curative optionRisk myelodysplastic syndromesDuration of responseBone marrow assessmentPembrolizumab Plus Chemotherapy Followed by Pembrolizumab in Patients With Early Triple-Negative Breast Cancer
Takahashi M, Cortés J, Dent R, Pusztai L, McArthur H, Kümmel S, Denkert C, Park Y, Im S, Ahn J, Mukai H, Huang C, Chen S, Kim M, Jia L, Li X, Tryfonidis K, Karantza V, Iwata H, Schmid P. Pembrolizumab Plus Chemotherapy Followed by Pembrolizumab in Patients With Early Triple-Negative Breast Cancer. JAMA Network Open 2023, 6: e2342107. PMID: 37966841, PMCID: PMC10652156, DOI: 10.1001/jamanetworkopen.2023.42107.Peer-Reviewed Original ResearchConceptsEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalPathologic complete responseChemotherapy groupNeoadjuvant chemotherapyBreast cancerNeoadjuvant pembrolizumabDefinitive surgeryComplete responseMAIN OUTCOMEEastern Cooperative Oncology Group performance statusCell death ligand 1 (PD-L1) statusDeath ligand 1 (PD-L1) statusTreatment-related adverse eventsNonmetastatic triple-negative breast cancerCycles of pembrolizumabPembrolizumab Plus ChemotherapyTumor PD-L1Unacceptable toxic effectsPD-L1 statusOverall survival analysisAdjuvant pembrolizumabEFS eventsEFS ratesEffects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)
Shitara K, George B, Taieb J, Sundar R, Fakih M, Makris L, Benhadji K, Ghidini M. Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS). Journal Of Cancer Research And Clinical Oncology 2023, 149: 9361-9374. PMID: 37213030, PMCID: PMC10374776, DOI: 10.1007/s00432-023-04813-z.Peer-Reviewed Original ResearchConceptsProgression-free survivalGastric/gastroesophageal junction cancerJunction cancerSurvival benefitSafety profileEastern Cooperative Oncology Group performance statusRandomized phase III trialAssociated with survival benefitMedian overall survivalPhase III trialsPost hoc exploratory analysisLater-lineTrifluridine/tipiracil treatmentHematologic toxicityPrior therapyMedian overallOverall survivalIII trialsPlacebo armPerformance statusResultsBaseline characteristicsMedian timeRamucirumabTherapy patternsClinical trialsTrastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial
André F, Hee Park Y, Kim S, Takano T, Im S, Borges G, Lima J, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux F, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. The Lancet 2023, 401: 1773-1785. PMID: 37086745, DOI: 10.1016/s0140-6736(23)00725-0.Peer-Reviewed Original ResearchConceptsHER2-positive metastatic breast cancerMetastatic breast cancerPhysician's choice groupTreatment-emergent adverse eventsBlinded independent central reviewPhase 3 trialProgression-free survivalTrastuzumab deruxtecanIndependent central reviewBreast cancerPhysician's choiceAdverse eventsCentral reviewTrastuzumab emtansineEastern Cooperative Oncology Group performance statusCommon treatment-emergent adverse eventsHigher treatment-emergent adverse eventsMedian progression-free survivalPositive metastatic breast cancerFavorable benefit-risk profilePalmar-plantar erythrodysaesthesiaInterstitial lung diseaseBenefit-risk profileAntibody-drug conjugatesChoice groupAdjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial
Tolaney S, Tarantino P, Graham N, Tayob N, Parè L, Villacampa G, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo J, Weiss J, Wagle N, Partridge A, Waks A, Hudis C, Krop I, Burstein H, Prat A, Winer E. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. The Lancet Oncology 2023, 24: 273-285. PMID: 36858723, DOI: 10.1016/s1470-2045(23)00051-7.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerInvasive disease-free survivalDisease-free survivalRecurrence-free intervalAdjuvant paclitaxelBreast cancerEastern Cooperative Oncology Group performance statusInvasive disease-free survival eventsDisease-free survival eventsHormone receptor-positive diseaseNew contralateral breast cancerBreast cancer-specific survivalProtocol-defined treatmentCancer-specific survivalReceptor-positive diseasePhase 2 studyContralateral breast cancerLong-term outcomesAPT trialCause deathEligible patientsIntravenous paclitaxelTrastuzumab weeklyDistant recurrenceIpsilateral recurrenceTrial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations.
Tolcher A, Park W, Wang J, Spira A, Janne P, Lee H, Gill S, LoRusso P, Herzberg B, Goldman J, Morgensztern D, Berlin J, Kasi A, Fujii H, Pelster M. Trial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations. Journal Of Clinical Oncology 2023, 41: tps764-tps764. DOI: 10.1200/jco.2023.41.4_suppl.tps764.Peer-Reviewed Original ResearchKRAS G12DAdverse eventsLung cancerKRAS G12D mutationCancer cellsEastern Cooperative Oncology Group performance statusSolid tumorsNon-small cell lung cancerMetastatic solid tumor malignanciesSolid Tumors version 1.1Dose-escalation cohortsDose-expansion studyPhase 2 doseDisease control rateObjective response rateSerious adverse eventsAdvanced solid tumorsResponse Evaluation CriteriaDose-limiting toxicityPancreatic ductal cancerPhase 1 studyCell lung cancerDuration of responseSolid tumor malignanciesG12D mutationCisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial
Rodler E, Sharma P, Barlow W, Gralow J, Puhalla S, Anders C, Goldstein L, Tripathy D, Brown-Glaberman U, Huynh T, Szyarto C, Godwin A, Pathak H, Swisher E, Radke M, Timms K, Lew D, Miao J, Pusztai L, Hayes D, Hortobagyi G. Cisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncology 2023, 24: 162-174. PMID: 36623515, PMCID: PMC9924094, DOI: 10.1016/s1470-2045(22)00739-2.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerMedian progression-free survivalProgression-free survivalMetastatic breast cancerMetastatic triple-negative breast cancerGermline BRCA1/2Phase 2 trialVeliparib groupPlacebo groupPlatinum-based chemotherapyBreast cancerHomologous recombination deficiencyAdverse eventsPARP inhibitorsEligible patientsMetastatic diseaseEastern Cooperative Oncology Group performance statusBRCA mutation-associated breast cancerInvestigator-assessed progression-free survivalTreatment-related adverse eventsRecurrent triple-negative breast cancerAcademic clinical sitesAddition of veliparibCommon grade 3Lines of chemotherapy
2022
Efficacy of next line of therapy after treatment with lenvatinib (LEN) in combination with pembrolizumab (pembro) versus treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Exploratory analysis of Study 309/KEYNOTE-775.
Makker V, Colombo N, Santin A, Miller D, Fujiwara K, Pignata S, Ray-Coquard I, Kim Y, Guerra E, Huang J, Barresi G, McKenzie J, Lorusso D. Efficacy of next line of therapy after treatment with lenvatinib (LEN) in combination with pembrolizumab (pembro) versus treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Exploratory analysis of Study 309/KEYNOTE-775. Journal Of Clinical Oncology 2022, 40: 5587-5587. DOI: 10.1200/jco.2022.40.16_suppl.5587.Peer-Reviewed Original ResearchAdvanced endometrial cancerComers populationTPC armEastern Cooperative Oncology Group performance statusPrior platinum-based chemotherapy regimenPlatinum-based chemotherapy regimenObjective response rateOverall survival benefitPrespecified exploratory analysisSystemic anticancer therapyPlatinum-based treatmentMedian PFS2PMMR tumorsChemotherapy regimenPelvic radiationData cutoffPerformance statusEndometrial cancerInvestigator assessmentSurvival benefitStudy treatmentMMR statusLenvatinibPembroPhysician's choice
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