2025
ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor–Mutated Advanced Non–Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib
Riess J, de Langen A, Ponce S, Goldberg S, Piotrowska Z, Goldman J, Le X, Cho B, Yoneshima Y, Ambrose H, Cavazzina R, Tang K, Lau J, Yu H. ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor–Mutated Advanced Non–Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib. JCO Precision Oncology 2025, 9: e2400818. PMID: 40466026, DOI: 10.1200/po-24-00818.Peer-Reviewed Original ResearchMeSH KeywordsAcrylamidesAdultAgedAged, 80 and overAniline CompoundsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDisease ProgressionErbB ReceptorsFemaleHumansIndolesLung NeoplasmsMaleMiddle AgedMutationPyrimidinesConceptsAdvanced non-small cell lung cancerNon-small cell lung cancerCell lung cancerLung cancerEpidermal growth factor receptor alterationsFirst-line osimertinibSafety of osimertinibProgression-free survivalDuration of responseNovel drug combinationsData cutoffPartial responseOsimertinib resistanceRisk-benefit analysisOverall survivalReceptor alterationsDiscontinued treatmentInvestigator assessmentClinical benefitNecitumumabSafety profileOsimertinibReport final resultsAdverse eventsDrug combinationsSmall Cell Lung Cancer
Kim S, Park H, Chiang A. Small Cell Lung Cancer. JAMA 2025, 333: 1906-1917. PMID: 40163214, DOI: 10.1001/jama.2025.0560.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapy, AdjuvantChemotherapy, AdjuvantCigarette SmokingHumansImmune Checkpoint InhibitorsImmunotherapyIncidenceLungLung NeoplasmsNeoplasm StagingPneumonectomyProgression-Free SurvivalRisk FactorsSmall Cell Lung CarcinomaConceptsSmall cell lung cancerFirst-line treatmentCell lung cancerES-SCLCLS-SCLCLung cancerPlatinum-etoposideMaintenance immunotherapyOverall survivalMedian overall survival of patientsCell death 1 ligand 1Programmed cell death 1 ligand 1Rate of tumor shrinkageHigh-grade neuroendocrine carcinomaThree-year overall survivalBispecific T-cell engagerDelta-like ligand 3Overall survival of patientsDevelopment of small cell lung cancerPlatinum-etoposide chemotherapyPrimary lung massMedian overall survivalSecond-line therapyT-cell engagersSmoking-related malignanciesPerioperative nivolumab and chemotherapy in locally advanced squamous cell carcinoma of the oesophagus: a randomized multicentre phase 2 study with circulating tumor DNA dynamics monitoring
Jiao H, Lin S, Gu J, Jiang D, Cui P, Huang Z, Fang Y, Wang H, Lin M, Tang H, Jiang T, Lin G, Zhang S, Yin H, Liang F, Wang J, Fan X, Qiu F, Yang Y, Li Z, Li B, Xiang J, Leng X, Han Y, Li C, Ai L, Hou Y, Wang G, Zhang Z, Cai S, Liu T, Yin J, Tan L. Perioperative nivolumab and chemotherapy in locally advanced squamous cell carcinoma of the oesophagus: a randomized multicentre phase 2 study with circulating tumor DNA dynamics monitoring. Molecular Cancer 2025, 24: 143. PMID: 40375301, PMCID: PMC12079821, DOI: 10.1186/s12943-025-02332-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCirculating Tumor DNACisplatinEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaFemaleHumansMaleMiddle AgedNivolumabPrognosisTreatment OutcomeConceptsCirculating tumor DNAOesophageal squamous cell carcinomaPathological complete responseResectable oesophageal squamous cell carcinomaPathologic complete response rateR0 resection ratePhase 2 studySquamous cell carcinomaNivolumab groupResection rateCell carcinomaLocally advanced squamous cell carcinomaTreating oesophageal squamous cell carcinomaTwo-year overall survival ratesCirculating tumor DNA dynamicsMulticenter phase 2 studyMulticentre phase 2 studyAdvanced squamous cell carcinomaCirculating tumor DNA levelsEvent-free survival rateMedian follow-up durationEffect of adjuvant therapyLong-term survival dataMonitoring minimal residual diseaseIntention-to-treat populationForecasting optimal treatments in relapsed/refractory mature T‐ and NK‐cell lymphomas: A global PETAL Consortium study
Sorial M, Han J, Koh M, Boussi L, Li S, Duan R, Lu J, Lei M, MacVicar C, Freydman J, Malespini J, Aniagboso K, McCabe S, Peng L, Singh S, Iwasaki M, Eche‐Ugwu I, Gabler J, Turizo M, Garg A, Disciullo A, Chopra K, Ford J, Lenart A, Nwodo E, Barnes J, Koh M, Miranda E, Chiattone C, Stuver R, Merrill M, Jacobsen E, Manni M, Civallero M, Skrypets T, Lymboussaki A, Federico M, Kim Y, Kim J, Cho J, Eipe T, Shet T, Epari S, Shetty A, Saha S, Jain H, Sengar M, Van Der Weyden C, Prince H, Hamouche R, Muradashvili T, Foss F, Gentilini M, Casadei B, Zinzani P, Okatani T, Yoshida N, Yoon S, Kim W, Panchoo G, Mohamed Z, Verburgh E, Alturas J, Al‐Mansour M, Cabrera M, Ku A, Bhagat G, Ma H, Sawas A, Kariya K, Bhanushali F, Meharwal A, Mistry D, Kosovsky M, Yeterian M, O'Connor O, Marchi E, Shen C, Shah D, Jain S. Forecasting optimal treatments in relapsed/refractory mature T‐ and NK‐cell lymphomas: A global PETAL Consortium study. British Journal Of Haematology 2025, 206: 1664-1677. PMID: 40310502, PMCID: PMC12167149, DOI: 10.1111/bjh.20063.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansLymphoma, Extranodal NK-T-CellLymphoma, T-CellMaleMiddle AgedRecurrenceRetrospective StudiesConceptsT-cell lymphomaCytotoxic chemotherapySmall molecule inhibitorsEpigenetic modifiersAngioimmunoblastic T-cell lymphomaPrimary refractory diseaseNK-cell lymphomasHigh-risk groupTransplant consolidationOverall survivalRefractory diseaseNK cellsPrognostic indexT cellsIdeal therapyMature TOptimal treatmentLymphomaGlobal cohortTreatment sequenceMolecule inhibitorsPatientsThird lineConsortium studyTreatmentNeoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163.
Saba N, Flamand Y, Lin D, Chung C, McDonald M, Flampouri S, Khan S, Snyderman C, Hanna E, El-Sayed I, Solares C, Le C, Ghaly M, Hwang P, Shin D, Axelrod R, Ikpeazu C, Adkins D, Duan F, Cohen M, Samuels M, Swiecicki P, Subramaniam R, Chakravarthy A, Burtness B. Neoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163. Clinical Cancer Research 2025, 31: 2339-2346. PMID: 40227186, PMCID: PMC12165817, DOI: 10.1158/1078-0432.ccr-24-4085.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCisplatinCombined Modality TherapyDocetaxelFemaleHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm StagingNose NeoplasmsOrgan Sparing TreatmentsParanasal Sinus NeoplasmsTreatment OutcomeConceptsSinus squamous cell carcinomaNeoadjuvant chemotherapySquamous cell carcinomaOverall survivalArm BOne-sided alphaArm ACell carcinomaRandomized studyArm A versus BSP ratesGrade 5 eventsCo-primary objectivesSingle-institution studyA versus BLog-rank testFisher's exact testPreservation rateExact testChemotherapyOrgan preservationSurgeryPatientsT3/T4aCarcinomaPembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up from the randomized phase III KEYNOTE-048 study
Tahara M, Greil R, Rischin D, Harrington K, Burtness B, de Castro G, Psyrri A, Braña I, Neupane P, Bratland Å, Fuereder T, Hughes B, Mesía R, Ngamphaiboon N, Rordorf T, Ishak W, Lin J, Gumuscu B, Lerman N, Soulières D. Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up from the randomized phase III KEYNOTE-048 study. European Journal Of Cancer 2025, 221: 115395. PMID: 40262400, DOI: 10.1016/j.ejca.2025.115395.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsCetuximabFemaleFollow-Up StudiesHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProgression-Free SurvivalSquamous Cell Carcinoma of Head and NeckConceptsProgression-free survivalHead and neck squamous cell carcinomaNeck squamous cell carcinomaPembrolizumab-chemotherapySquamous cell carcinomaR/M HNSCCOverall survivalFollow-upMedian OSPD-L1Cell carcinomaRecurrent/metastatic head and neck squamous cell carcinomaMetastatic head and neck squamous cell carcinomaProgrammed cell death ligand 1Median study follow-upCell death ligand 1Prolonged median OSFirst-line settingDeath-ligand 1Years of follow-upFollow-up resultsStudy follow-upStandard of careCetuximab chemotherapyPembrolizumab monotherapyA phase 1 study of durvalumab as monotherapy or combined with tremelimumab with or without azacitidine in patients with myelodysplastic syndrome
Garcia-Manero G, Gaddh M, Platzbecker U, Lindsley R, Larson S, Chevassut T, Fenaux P, Komrokji R, Lyons R, Al-Kali A, Jiang Y, Bothos J, Townsley D, Zeidan A. A phase 1 study of durvalumab as monotherapy or combined with tremelimumab with or without azacitidine in patients with myelodysplastic syndrome. Annals Of Hematology 2025, 104: 1577-1585. PMID: 40153010, PMCID: PMC12031784, DOI: 10.1007/s00277-024-06081-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineFemaleHumansMaleMiddle AgedMyelodysplastic SyndromesConceptsTreatment-emergent adverse eventsDose-limiting toxicityPhase 1 studyPD-L1Adverse eventsUpregulation of programmed death ligand 1Marrow complete responseDeath-ligand 1Hypomethylating agent treatmentPrimary safety endpointProgression to AMLEvaluation of clinical outcomesComplete responseHematologic improvementIWG criteriaMyelodysplastic syndromeOpen-labelSecondary endpointsSafety endpointsClinical outcomesLimited efficacyPatientsLigand 1Agent treatmentOverall responseA Phase I, First-in-Human, Dose-Escalation, Expansion Trial of Cytokine-Encoding Synthetic mRNA Mixture Alone or with Cemiplimab in Advanced Solid Tumors
Bechter O, Loquai C, Champiat S, Baurain J, Grob J, Utikal J, Rottey S, Berrocal A, Hassel J, Arance A, Sanmamed M, Boers-Sonderen M, Gastman B, Gebhardt C, Delafontaine B, Sahin U, Türeci Ö, Brueck P, Abbadessa G, Marpadga R, Lee H, Yang Y, Buday B, Di Genova G, Wang H, Xia B, Lee J, Lebbe C. A Phase I, First-in-Human, Dose-Escalation, Expansion Trial of Cytokine-Encoding Synthetic mRNA Mixture Alone or with Cemiplimab in Advanced Solid Tumors. Clinical Cancer Research 2025, 31: 2358-2369. PMID: 40152791, PMCID: PMC12163594, DOI: 10.1158/1078-0432.ccr-24-1983.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCytokinesFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansInterferon alpha-2Interleukin-12Interleukin-15MaleMaximum Tolerated DoseMiddle AgedNeoplasmsRNA, MessengerTreatment OutcomeConceptsAdvanced solid tumorsMaximum administered doseSolid tumorsCombination therapyEscalation phaseTreated with anti-PD-1 therapyTreated with anticancer therapyAnti-PD-1 therapyTreatment-related adverse eventsDose level 8Predefined dose levelsInjection-site painFirst-in-humanPlasma cytokine concentrationsDose escalationAntitumor responsePartial responseIntratumoral administrationExpansion trialIL-15IFN-gCemiplimabAdverse eventsCytokine concentrationsDose levelsImmune-related adverse events are associated with better event-free survival in a phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early-stage triple-negative breast cancer
Rios-Hoyo A, Dai J, Noel T, Blenman K, Park T, Pusztai L. Immune-related adverse events are associated with better event-free survival in a phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early-stage triple-negative breast cancer. ESMO Open 2025, 10: 104494. PMID: 40107153, PMCID: PMC11964624, DOI: 10.1016/j.esmoop.2025.104494.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm StagingPaclitaxelTriple Negative Breast NeoplasmsConceptsImmune-related adverse eventsTriple-negative breast cancerEvent-free survivalResidual cancer burdenDevelopment of immune-related adverse eventsOverall survivalAdverse eventsLandmark analysisAssociated with better event-free survivalBreast cancerEarly-stage triple-negative breast cancerFrequent immune-related adverse eventsMultiple immune-related adverse eventsEvent-free survival eventsRCB 0Immune checkpoint inhibitor therapyPhase I/II clinical trialsPathological complete responseSingle-arm clinical trialCheckpoint inhibitor therapyImmune checkpoint therapyMedian follow-upTime of surgeryYale Cancer CenterAdministered post-operativelyEpigenetic therapy sensitizes anti–PD-1 refractory head and neck cancers to immunotherapy rechallenge
Qin T, Mattox A, Campbell J, Park J, Shin K, Li S, Sadow P, Faquin W, Micevic G, Daniels A, Haddad R, Garris C, Pittet M, Mempel T, ONeill A, Sartor M, Pai S. Epigenetic therapy sensitizes anti–PD-1 refractory head and neck cancers to immunotherapy rechallenge. Journal Of Clinical Investigation 2025, 135: e181671. PMID: 40091844, PMCID: PMC11910227, DOI: 10.1172/jci181671.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineB7-H1 AntigenEpigenesis, GeneticFemaleHead and Neck NeoplasmsHumansImmune Checkpoint InhibitorsImmunotherapyMaleMiddle AgedProgrammed Cell Death 1 ReceptorSquamous Cell Carcinoma of Head and NeckTumor MicroenvironmentConceptsHead and neck squamous cell carcinomaTumor microenvironmentProlonged OSOverall survivalIFN-gCD8+ T cell infiltrationCD4+ T regulatory cellsOn-treatment tumor biopsiesNeck squamous cell carcinomaSystemic host immune responseBackgroundImmune checkpoint blockadeMetastatic (R/MMedian overall survivalPD-L1 expressionT cell infiltrationLocal tumor microenvironmentT regulatory cellsSquamous cell carcinomaBiologically effective dosePhase 1b clinical trialHost immune responseCheckpoint blockadeOS ratesPD-L1Tumor biopsiesStandard‐Dose Versus High‐Dose Cisplatin for Intermediate/Poor‐Risk Extracranial Malignant Germ Cell Tumors: Re‐Analysis of Pediatric Oncology Group 9049 and Children's Cancer Group 8882 Trial Using Updated MaGIC Risk Stratification
Prior D, Yang J, Nuño M, Shaikh F, Frazier A, Pashankar F. Standard‐Dose Versus High‐Dose Cisplatin for Intermediate/Poor‐Risk Extracranial Malignant Germ Cell Tumors: Re‐Analysis of Pediatric Oncology Group 9049 and Children's Cancer Group 8882 Trial Using Updated MaGIC Risk Stratification. Pediatric Blood & Cancer 2025, 72: e31665. PMID: 40098231, PMCID: PMC12018124, DOI: 10.1002/pbc.31665.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntineoplastic Combined Chemotherapy ProtocolsBleomycinChildChild, PreschoolCisplatinClinical Trials, Phase II as TopicEtoposideFemaleFollow-Up StudiesHumansMaleMediastinal NeoplasmsMulticenter Studies as TopicNeoplasms, Germ Cell and EmbryonalOvarian NeoplasmsPrognosisRetroperitoneal NeoplasmsRisk AssessmentSecondary Data AnalysisSurvival RateTesticular NeoplasmsConceptsGerm cell tumorsEvent-free survivalOverall survivalStandard of careRisk stratificationCell tumorsExtracranial malignant germ cell tumorsHigh-risk germ cell tumorsMalignant Germ Cell International ConsortiumRetroperitoneal germ cell tumorsOvarian germ cell tumorsMalignant germ cell tumorsHigh-dose cisplatinChildren's Cancer GroupYears of ageStatistically significant differenceMediastinal primaryGCT patientsIntergroup trialPoor riskHDPEBHigh-doseRandomized patientsAdolescent patientsPoor prognosisDeterminants of response and molecular dynamics in HER2+ER+ breast cancers from the NA-PHER2 trial receiving HER2-targeted and endocrine therapies
Callari M, Dugo M, Barreca M, Győrffy B, Galbardi B, Vigano L, Locatelli A, Dall’Ara C, Ferrarini M, Bisagni G, Colleoni M, Mansutti M, Zamagni C, Del Mastro L, Zambelli S, Frassoldati A, Biasi O, Pusztai L, Valagussa P, Viale G, Gianni L, Bianchini G. Determinants of response and molecular dynamics in HER2+ER+ breast cancers from the NA-PHER2 trial receiving HER2-targeted and endocrine therapies. Nature Communications 2025, 16: 2195. PMID: 40038334, PMCID: PMC11880565, DOI: 10.1038/s41467-025-57293-9.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsFemaleHumansKi-67 AntigenLymphocytes, Tumor-InfiltratingMiddle AgedMutationReceptor, ErbB-2Receptors, EstrogenTrastuzumabTreatment OutcomeConceptsTumor-infiltrating lymphocytesBreast cancerEndocrine therapyImmune infiltrationPrediction of pCRAnti-HER2 therapyLuminal A phenotypeHigher immune infiltrationFemale breast cancerHER2 blockadeDeterminants of responseTumor responseInfiltrating lymphocytesCDK4/6 inhibitionAnti-HER2HER2 targetingClinical endpointsER signalingKi67Response groupCancerTherapyTherapeutic targetMolecular changesTumorSafety and Antitumor Activity of a Novel aCD25 Treg Depleter RG6292 as a Single Agent and in Combination with Atezolizumab in Patients with Solid Tumors
Gambardella V, Ong M, Rodriguez-Ruiz M, Machiels J, Sanmamed M, Galvao V, Spreafico A, Renouf D, Luen S, Galot R, de Spéville B, Calvo E, Naing A, Curdt S, Kolben T, Rossmann E, Tanos T, Smart K, Amann M, Xie Y, Xu L, Alcaide E, Städler N, Justies N, Boetsch C, Karanikas V, Schnetzler G, Rohrberg K. Safety and Antitumor Activity of a Novel aCD25 Treg Depleter RG6292 as a Single Agent and in Combination with Atezolizumab in Patients with Solid Tumors. Cancer Research Communications 2025, 5: 422-432. PMID: 39983024, PMCID: PMC11891644, DOI: 10.1158/2767-9764.crc-24-0638.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansInterleukin-2 Receptor alpha SubunitMaleMaximum Tolerated DoseMiddle AgedNeoplasmsT-Lymphocytes, RegulatoryConceptsRecommended phase II dosePhase II doseMaximum tolerated dosePhase I studyTreg depletionSolid tumorsII doseTolerated doseResistance to cancer immunotherapyRegulatory T-cell depletionImmunosuppressive regulatory T cellsEffector T cell functionAdvanced solid tumorsT-cell depletionRegulatory T cellsAnti-CD25 antibodyFrequent adverse eventsT cell functionDose-dependent depletionIL-2 signalingAtezolizumab combinationDeplete TregsTreg reductionDose escalationPeripheral TregsFAK inhibition combined with the RAF-MEK clamp avutometinib overcomes resistance to targeted and immune therapies in BRAF V600E melanoma
Lubrano S, Cervantes-Villagrana R, Faraji F, Ramirez S, Sato K, Adame-Garcia S, Officer A, Arang N, Rigiracciolo D, Anguiano Quiroz P, Martini C, Wang Y, Ferguson F, Bacchiocchi A, Halaban R, Coma S, Holmen S, Pachter J, Aplin A, Gutkind J. FAK inhibition combined with the RAF-MEK clamp avutometinib overcomes resistance to targeted and immune therapies in BRAF V600E melanoma. Cancer Cell 2025, 43: 428-445.e6. PMID: 40020669, PMCID: PMC11903146, DOI: 10.1016/j.ccell.2025.02.001.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Combined Chemotherapy ProtocolsApoptosisCell Line, TumorDrug Resistance, NeoplasmFocal Adhesion Kinase 1HumansImmunotherapyMAP Kinase Signaling SystemMelanomaMiceMutationProtein Kinase InhibitorsProto-Oncogene Proteins B-rafXenograft Model Antitumor AssaysConceptsBRAF V600E melanomaFocal adhesion kinaseV600E melanomaFAK inhibitorActivated focal adhesion kinaseFocal adhesion kinase inhibitionRaf-MEKActivation of focal adhesion signalingFocal adhesion kinase inhibitorResistance to BRAFiSyngeneic mouse modelMAPK pathway inhibitionFocal adhesion signalingPro-apoptotic activityMelanoma patientsAdhesion signalingImmune therapyBRAF mutationsBRAFiTranscriptome analysisMelanomaMouse modelPathway inhibitionBRAFMelanoma cellsSelinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design
Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Chai Y, Kye S, Method M, Harrison C. Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design. Future Oncology 2025, 21: 807-813. PMID: 39911057, PMCID: PMC11916360, DOI: 10.1080/14796694.2025.2461393.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodFemaleHumansHydrazinesJanus Kinase InhibitorsMaleMiddle AgedNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesTreatment OutcomeTriazolesConceptsJAK inhibitorsNo dose limiting toxicitiesDose-limiting toxicityAbsolute mean changeSpleen volume reductionPlacebo-controlled studyBaseline to weekTreatment of patientsDose expansionDose escalationLimiting toxicitiesDouble-blindPrimary endpointPhase 3 study designXPO1 inhibitorsMean changeRuxolitinibPatientsSelinexorVolume reductionDosePhase 3InhibitorsJAKMyelofibrosisAsciminib plus dasatinib and prednisone for Philadelphia chromosome–positive acute leukemia
Luskin M, Murakami M, Keating J, Flamand Y, Winer E, Garcia J, Stahl M, Stone R, Wadleigh M, Jaeckle S, Hagopian E, Weinstock D, Liegel J, McMasters M, Wang E, Stock W, DeAngelo D. Asciminib plus dasatinib and prednisone for Philadelphia chromosome–positive acute leukemia. Blood 2025, 145: 577-589. PMID: 39374521, DOI: 10.1182/blood.2024025800.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDasatinibFemaleFusion Proteins, bcr-ablHumansLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedNiacinamidePhiladelphia ChromosomePrecursor Cell Lymphoblastic Leukemia-LymphomaPrednisonePyrazolesConceptsAcute leukemiaPhiladelphia chromosome-positive acute leukemiaRecommended phase 2 dosePh+ acute lymphoblastic leukemiaHematopoietic stem cell transplantationDe novo ALLHematologic remission rateLymphoid blast crisisMaximum tolerated doseStem cell transplantationPhase 1 studyChronic myeloid leukemiaMulticolor flow cytometryAcute lymphoblastic leukemiaVaso-occlusive eventsCytogenetic remissionBlast crisisSymptomatic pancreatitisTolerated doseRemission ratePh+ ALLCell transplantationMedian ageEnzyme elevationLymphoblastic leukemiaPhase Ib Study of Immunocytokine Simlukafusp Alfa (FAP-IL2v) Combined with Pembrolizumab for Treatment of Advanced and/or Metastatic Melanoma
Munoz-Couselo E, Rivas A, Sandhu S, Long G, Sanmamed M, Spreafico A, Buchbinder E, Sznol M, Prenen H, Fedenko A, Milhem M, Fernandez A, Grob J, Demidov L, Robert C, Habigt C, Evers S, Sleiman N, Dejardin D, Ardeshir C, Martin N, Boetsch C, Charo J, Teichgräber V, Kraxner A, Keshelava N, Bechter O. Phase Ib Study of Immunocytokine Simlukafusp Alfa (FAP-IL2v) Combined with Pembrolizumab for Treatment of Advanced and/or Metastatic Melanoma. Cancer Research Communications 2025, 5: 358-368. PMID: 39895413, PMCID: PMC11848832, DOI: 10.1158/2767-9764.crc-24-0601.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEndopeptidasesFemaleHumansInterleukin-2MaleMelanomaMembrane ProteinsMiddle AgedSkin NeoplasmsConceptsPhase Ib studyMetastatic melanomaFibroblast activation proteinSafety profileLack of clinical activityPhase Ib clinical studySafety run-in cohortAntitumor activityProgression-free survivalCD8 T cellsInfusion-related reactionsElevated alanine aminotransferaseQ3W dosingOpen-labelPembrolizumabT cellsAdverse eventsClinical studiesIb studyClinical activityExtension cohortMelanomaPatientsAlanine aminotransferaseInduction phaseTransarterial 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 ResearchMeSH KeywordsAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularChemoembolization, TherapeuticDouble-Blind MethodFemaleHumansLiver NeoplasmsMaleMiddle AgedPhenylurea CompoundsProgression-Free SurvivalQuinolinesConceptsEastern 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-upAutogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial
Lopez J, Powles T, Braiteh F, Siu L, LoRusso P, Friedman C, Balmanoukian A, Gordon M, Yachnin J, Rottey S, Karydis I, Fisher G, Schmidt M, Schuler M, Sullivan R, Burris H, Galvao V, Henick B, Dirix L, Jaeger D, Ott P, Wong K, Jerusalem G, Schiza A, Fong L, Steeghs N, Leidner R, Rittmeyer A, Laurie S, Gort E, Aljumaily R, Melero I, Sabado R, Rhee I, Mancuso M, Muller L, Fine G, Yadav M, Kim L, Leveque V, Robert A, Darwish M, Qi T, Zhu J, Zhang J, Twomey P, Rao G, Low D, Petry C, Lo A, Schartner J, Delamarre L, Mellman I, Löwer M, Müller F, Derhovanessian E, Cortini A, Manning L, Maurus D, Brachtendorf S, Lörks V, Omokoko T, Godehardt E, Becker D, Hawner C, Wallrapp C, Albrecht C, Kröner C, Tadmor A, Diekmann J, Vormehr M, Jork A, Paruzynski A, Lang M, Blake J, Hennig O, Kuhn A, Sahin U, Türeci Ö, Camidge D. Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial. Nature Medicine 2025, 31: 152-164. PMID: 39762422, PMCID: PMC11750724, DOI: 10.1038/s41591-024-03334-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsCD8-Positive T-LymphocytesFemaleHumansImmunotherapyMaleMiddle AgedNeoplasmsConceptsCD8+ T cellsAdvanced solid tumorsT cellsSolid tumorsCirculating CD8+ T cellsEfficacy of cancer immunotherapyTumor-infiltrating T cellsStimulate T cell responsesResponse to immunotherapyT cell responsesPreliminary antitumor activityPhase 1 studyPhase 1 trialDose escalationPretreated patientsCancer immunotherapyEvaluation of pharmacokineticsCD4+Tumor lesionsTreatment initiationTumor tissuesAtezolizumabClinical activityDisease characteristicsImmunotherapyAdjuvant Dose-Dense Chemotherapy in Hormone Receptor–Positive Breast Cancer
Filho O, Ballman K, Campbell J, Liu M, Ligibel J, Watson M, Chen E, Du L, Stover D, Carey L, Partridge A, Kirshner J, Muss H, Hudis C, Winer E, Norton L, Symmans W. Adjuvant Dose-Dense Chemotherapy in Hormone Receptor–Positive Breast Cancer. Journal Of Clinical Oncology 2025, 43: 1229-1239. PMID: 39746162, PMCID: PMC11954676, DOI: 10.1200/jco-24-01875.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDose-Response Relationship, DrugFemaleHumansMiddle AgedPrognosisReceptors, EstrogenConceptsDose-dense chemotherapyDisease-free survivalOverall survivalBreast cancerTumor burdenMenopausal statusLong-term disease-free survivalHormone receptor-positive breast cancerHazard ratioNode-positive breast cancerSensitivity to endocrine therapyReceptor-positive breast cancerDose-dense therapyER-negative subsetEstrogen receptor-positiveER+ breast cancerMolecular subtype classificationSustained long-term benefitsER+ cancersDose-denseER statusReceptor-positiveEndocrine therapyConventional chemotherapyChemotherapy schedule
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