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 ResearchConceptsAdvanced 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 combinationsLatent EBV enhances the efficacy of anti-CD3 mAb in Type 1 diabetes
Lledó-Delgado A, Preston-Hurlburt P, Higdon L, Hu A, James E, Lim N, Long S, McNamara J, Nguyen H, Serti E, Sumida T, Herold K. Latent EBV enhances the efficacy of anti-CD3 mAb in Type 1 diabetes. Nature Communications 2025, 16: 5033. PMID: 40447640, PMCID: PMC12125364, DOI: 10.1038/s41467-025-60276-5.Peer-Reviewed Original ResearchConceptsCD8+ T cellsEBV-seropositive individualsType 1 diabetesT cellsImmune cellsAntigen-specific CD8+ T cellsDiagnosis of type 1 diabetesEBV-seronegative patientsEBV-seropositive patientsT cell activation pathwaysRegulatory T cellsAnti-CD3 mAbInnate immune cellsPeripheral blood cellsT cell receptorProgression of diseaseContext of type 1 diabetesImpaired signaling pathwaysTeplizumabClinical trialsLatent EBVBlood cellsSingle cell transcriptomicsModulate progressionMTOR signalingA Sticky Situation: Case Series of Successful Treatment of Glue Ear With Dupilumab
Kallenberger E, Kaur S, Everist B, Ator G, Gierer S, D’Mello A. A Sticky Situation: Case Series of Successful Treatment of Glue Ear With Dupilumab. Otology & Neurotology 2025, 46: e210-e214. PMID: 40360240, DOI: 10.1097/mao.0000000000004501.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedChronic DiseaseHearing LossHumansOtitis Media with EffusionRetrospective StudiesTreatment OutcomeConceptsChronic otitis mediaGlue earOtitis mediaTreatment of glue earPatient-reported incidencePatient-reported symptomsPresence of eosinophilic inflammationTreating chronic otitis mediaAudiometric dataInjection of dupilumabCase 2Efficacy of dupilumabHearing lossInterruption of treatmentNonsurgical treatment optionsEar painDupilumab therapyEar drainageEar infectionsSurgical treatmentEosinophilic inflammationCase seriesDupilumabAtopic conditionsTreatment optionsA Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects
Wang Y, Cheng Y, Guo Y, Fan Y, Zhou R, Zhang Q, Xu Y, Feng S, Shen K, Hu W. A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects. European Journal Of Drug Metabolism And Pharmacokinetics 2025, 50: 265-272. PMID: 40252193, DOI: 10.1007/s13318-025-00944-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedArea Under CurveAsian PeopleBiological AvailabilityChinaEast Asian PeopleFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedProprotein Convertase 9Young AdultConceptsProprotein convertase subtilisin/kexin type 9Healthy Chinese subjectsPhase I studySubcutaneous injectionChinese subjectsAdverse eventsRatios of maximum serum concentrationRelative bioavailabilitySerum concentrationsTreatment-emergent adverse eventsLow-density lipoprotein cholesterol levelsIncidence of antidrug antibodiesGeometric mean ratiosHuman monoclonal antibodyMaximum serum concentrationLipoprotein cholesterol levelsSite groupsSingle subcutaneous injectionsUpper armBioavailabilityOpen-labelAntidrug antibodiesAUC0-lastDays postdoseLipid variablesAdvancing patient evidence in XLH (APEX): rationale and design of a real-world XLH global data unification program
Brandi M, Carpenter T, Fukumoto S, Haffner D, Imel E, Kanematsu M, McCullough K, Ozono K. Advancing patient evidence in XLH (APEX): rationale and design of a real-world XLH global data unification program. Frontiers In Endocrinology 2025, 16: 1471127. PMID: 40260280, PMCID: PMC12009718, DOI: 10.3389/fendo.2025.1471127.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedChildFamilial Hypophosphatemic RicketsFibroblast Growth Factor-23HumansMaleMulticenter Studies as TopicObservational Studies as TopicRegistriesConceptsX-linked hypophosphatemiaRandomized clinical trialsExcessive fibroblast growth factor 23Human anti-FGF23 antibodyObservational studyPhosphate-regulating endopeptidase homologAnti-FGF23 antibodyFibroblast growth factor 23Renal phosphate wastingLong-term outcomesStudy of patientsLong-term observational studiesPatient-reported outcomesPatients evidenceOral phosphateDosing regimensBone turnoverDental healthSerum phosphateChronic hypophosphatemiaClinical decision-makingPhosphate wastingPathogenic variantsClinical trialsGastrointestinal disturbancesPembrolizumab 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 monotherapyMultiplex Spatial Proteomic Analysis of HER2–Positive Breast Tumors Reveals Unique Molecular and Immunologic Features Associated With Treatment Response
Hennessy M, Cimino-Mathews A, Carter J, Kachergus J, Ma Y, Leal J, Solnes L, Denbow R, Abramson V, Carey L, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Wahl R, Perez E, Huang C, Stearns V, Thompson E, Connolly R. Multiplex Spatial Proteomic Analysis of HER2–Positive Breast Tumors Reveals Unique Molecular and Immunologic Features Associated With Treatment Response. JCO Precision Oncology 2025, 9: e2400546. PMID: 40179327, PMCID: PMC11968088, DOI: 10.1200/po-24-00546.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedBiomarkers, TumorBreast NeoplasmsFemaleHumansMiddle AgedNeoadjuvant TherapyProteomicsReceptor, ErbB-2TrastuzumabTreatment OutcomeConceptsPrediction of pathological complete responseHER2-positive breast cancerBreast cancerAbundant tumorHematoxylin and eosin and immunohistochemistryClinical trialsEstrogen receptor (ER)-negativeStromal tumor-infiltrating lymphocytesHuman epidermal growth factor 2 (HER2)-positive breast cancerPathological complete responseTumor-infiltrating lymphocytesEpidermal growth factor receptor signalingImmune cell activationDigital spatial profilingImmune-based biomarkersGeoMx Digital Spatial ProfilerNanoString GeoMx Digital Spatial ProfilingGrowth factor receptor signalingBaseline Ki67Baseline tumorsComplete responseER-negativeBasal-likeTumor biopsiesImmunological featuresA 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 levelsMethodology for the international working group clinical practice guidelines on X-linked hypophosphatemia in children and adults
Ali D, Khan A, Mirza R, Appelman-Dijkstra N, Brandi M, Carpenter T, Chaussain C, Imel E, de Beur S, Florenzano P, Morrison A, Alrob H, Alexander R, Alsarraf F, Beck-Nielsen S, Biosse-Duplan M, Cohen-Solal M, Crowley R, Dandurand K, Filler G, Fukumoto S, Gagnon C, Goodyer P, Grasemann C, Grimbly C, Hussein S, Javaid M, Khan S, Khan A, Lehman A, Lems W, Lewiecki E, McDonnell C, Morgante E, Portale A, Rhee Y, Siggelkow H, Tosi L, Ward L, Guyatt G. Methodology for the international working group clinical practice guidelines on X-linked hypophosphatemia in children and adults. Journal Of Bone And Mineral Metabolism 2025, 43: 193-202. PMID: 40119067, DOI: 10.1007/s00774-025-01585-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedChildFamilial Hypophosphatemic RicketsFemaleHumansPractice Guidelines as TopicConceptsCertainty of evidenceGRADE recommendationsImpact of medical interventionsManagement of "X-linked hypophosphatemiaX-linked hypophosphatemiaClinical practice guidelinesPatient-important outcomesRisk of biasNarrative literature reviewClinical practice surveyPatient partnersGuideline methodologistsGuideline panelFindings tablePractice guidelinesSystematic reviewPractice surveyMedical interventionsPregnant womenRecommendation strengthTreatment recommendationsInternational expertsPatient populationComprehensive guidelinesBody of evidenceAvelumab first-line maintenance for advanced urothelial carcinoma: long-term outcomes from the JAVELIN Bladder 100 trial in older patients ☆
Gupta S, Duran M, Sridhar S, Powles T, Bellmunt J, Park S, Gurney H, Tsuchiya N, Petrylak D, Tomita Y, di Pietro A, Manitz J, Tyroller K, Hoffman J, Jacob N, Grivas P. Avelumab first-line maintenance for advanced urothelial carcinoma: long-term outcomes from the JAVELIN Bladder 100 trial in older patients ☆. ESMO Open 2025, 10: 104506. PMID: 40107155, PMCID: PMC11964637, DOI: 10.1016/j.esmoop.2025.104506.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Transitional CellFemaleHumansMaleMiddle AgedTreatment OutcomeUrinary Bladder NeoplasmsConceptsProgression-free survivalPlatinum-based chemotherapyOverall survivalUrothelial carcinomaProgression-free survival analysisOlder ageAdvanced urothelial carcinomaFirst-line maintenanceMetastatic urothelial carcinomaProlonged overall survivalPhase III trialsKaplan-Meier methodQuality-adjusted timeLong-term outcomesJAVELIN BladderMedian OSIII trialsFirst-linePrimary endpointAvelumabBladder cancerOlder patientsAge subgroupsSupportive carePatientsEpigenetic 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 biopsiesSystemic Therapies for Pediatric Alopecia Areata
Kalil L, Welch D, Heath C, Craiglow B. Systemic Therapies for Pediatric Alopecia Areata. Pediatric Dermatology 2025, 42: 36-42. PMID: 40044621, DOI: 10.1111/pde.15822.Peer-Reviewed Original ResearchMeSH KeywordsAdrenal Cortex HormonesAlopecia AreataAntibodies, Monoclonal, HumanizedChildDermatologic AgentsHumansImmunosuppressive AgentsJanus Kinase InhibitorsMinoxidilConceptsAlopecia areataSystemic therapyPediatric alopecia areataAutoimmune hair loss disorderJanus kinase inhibitorsHair loss disorderComorbid atopyOral minoxidilLong-term useSystemic corticosteroidsTopical therapySystemic treatmentPediatric AACase reportAdjunctive treatmentMild diseaseKinase inhibitorsImmunomodulatory medicinesTherapyExtensive involvementAdverse effectsNarrative reviewAreataPatientsTreatmentDeterminants 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 ResearchConceptsTumor-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 changesTumorEstimated Effectiveness of Nirsevimab Against Respiratory Syncytial Virus
Xu H, Aparicio C, Wats A, Araujo B, Pitzer V, Warren J, Shapiro E, Niccolai L, Weinberger D, Oliveira C. Estimated Effectiveness of Nirsevimab Against Respiratory Syncytial Virus. JAMA Network Open 2025, 8: e250380. PMID: 40063022, PMCID: PMC11894488, DOI: 10.1001/jamanetworkopen.2025.0380.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntiviral AgentsCase-Control StudiesFemaleHumansInfantMaleRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus, HumanTreatment OutcomeConceptsRSV-positive casesCase-control studyRSV infectionLRTI-associated hospitalizationsWeeks postimmunizationLong-acting monoclonal antibodiesTest-negative case-control studyClinical settingRespiratory syncytial virusMultivariate logistic regressionYale New Haven Health SystemRSV diseaseEmergency department dataState immunization registryRSV seasonSyncytial virusNirsevimabPolymerase chain reactionClinical trialsLRTIInfantsPotential confoundersMonoclonal antibodiesBroader outcomesDisease severitySafety 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 ResearchConceptsRecommended 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 TregsNanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers
Champiat S, Garralda E, Galvao V, Cassier P, Gomez-Roca C, Korakis I, Grell P, Naing A, LoRusso P, Mikyskova R, Podzimkova N, Reinis M, Ouali K, Schoenenberger A, Kiemle-Kallee J, Tillmanns S, Sachse R, Moebius U, Spisek R, Bechard D, Jelinkova L, Adkins I, Marabelle A. Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers. Cell Reports Medicine 2025, 6: 101967. PMID: 39933529, PMCID: PMC11866505, DOI: 10.1016/j.xcrm.2025.101967.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnimalsAntibodies, Monoclonal, HumanizedCD8-Positive T-LymphocytesFemaleHumansImmune Checkpoint InhibitorsKiller Cells, NaturalMacaca fascicularisMaleMiddle AgedNeoplasmsProgrammed Cell Death 1 ReceptorConceptsCD8<sup>+</sup> T cellsNatural killerT cellsAnti-programmed cell death protein 1Frequent treatment-emergent adverse eventsProportion of CD8<sup>+</sup> T cellsAnti-PD-1 pembrolizumabTreatment-emergent adverse eventsCell death protein 1Anti-PD-1Advanced/metastatic solid tumorsStimulated natural killerInjection site reactionsIL-15 receptorMouse tumor modelsPD-1NK cellsPeripheral bloodIL-15Safety profileSite reactionsSolid tumorsClinical efficacyAdverse eventsTumor modelDeterminants 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 ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedRegistriesConceptsNon-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-upInsights into treatment of patients with mycosis fungoides or Sézary syndrome using mogamulizumab
Foss F, Kim Y, Scarisbrick J, Akilov O, Ristuccia R, Dwyer K, Wu W, Bagot M. Insights into treatment of patients with mycosis fungoides or Sézary syndrome using mogamulizumab. Journal Of Dermatological Treatment 2025, 36: 2438794. PMID: 39894454, DOI: 10.1080/09546634.2024.2438794.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsFemaleHumansLymphopeniaMaleMiddle AgedMycosis FungoidesSezary SyndromeSkin NeoplasmsTreatment OutcomeVorinostatConceptsMogamulizumab-associated rashConcomitant steroid useSezary syndromeAdvanced diseaseMycosis fungoidesSteroid useResponse to mogamulizumabProportion of patientsPercentage of patientsTreatment of patientsConcomitant steroidsRelapsed/refractory patientsLong-term responseMogamulizumabNext treatmentPatient characteristicsPatientsLymphopeniaVorinostatPatient responseFungoidesPFSMycosisSyndromeTreatmentSafety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study
Antozzi C, Vu T, Ramchandren S, Nowak R, Farmakidis C, Bril V, De Bleecker J, Yang H, Minks E, Park J, Grudniak M, Smilowski M, Sevilla T, Hoffmann S, Sivakumar K, Suzuki Y, Youssef E, Sanga P, Karcher K, Zhu Y, Sheehan J, Sun H, Group T. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. The Lancet Neurology 2025, 24: 105-116. PMID: 39862879, DOI: 10.1016/s1474-4422(24)00498-8.Peer-Reviewed Original ResearchMeSH KeywordsActivities of Daily LivingAdultAgedAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleHumansMaleMiddle AgedMyasthenia GravisReceptors, CholinergicTreatment OutcomeConceptsStandard-of-care therapyLeast-squares mean changeOpen-label extension phaseDouble-blind phasePhase 3 studyPopulation of patientsMyasthenia gravisAdverse eventsAntibody-positivePlacebo groupDouble-blindStudy drugMG-ADLAssociated with dose-dependent reductionsDose of study drugLong-term disease controlMean changeIntention-to-treat populationIncidence of adverse eventsMG-ADL scoresPlacebo-controlled studyGeneralised myasthenia gravisPhase 2 studyBaseline to weekAnti-acetylcholine receptor
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