2025
Phase 2, multicenter study of frontline maintenance therapy with lifileucel plus pembrolizumab in advanced non-small cell lung cancer.
Creelan B, Gettinger S, Chesney J, Sukari A, He K, Lee S, Garon E, Nieva J, Martin-Liberal J, Rodriguez Moreno J, Zugazagoitia J, Doger de Spéville B, Josephs D, Gibney G, Thomas S, Samhouri Y, Samakoglu S, Feng M, Finckenstein F, Schoenfeld A. Phase 2, multicenter study of frontline maintenance therapy with lifileucel plus pembrolizumab in advanced non-small cell lung cancer. Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps8659.Peer-Reviewed Original ResearchMetastatic non-small cell lung cancerNon-small cell lung cancerTumor-infiltrating lymphocytesCell lung cancerStandard-of-careIL-2Advanced non-small cell lung cancerLung cancerIn vivo T-cell persistencePhase 2 open-label studyECOG performance status 0Treatment-emergent adverse eventsResponse rateFrontline maintenance therapySymptomatic brain metastasesComplete response rateDisease control rateDose of pembrolizumabPerformance status 0Platinum-doublet chemotherapyT cell persistenceCell transfer therapyCirculating tumor DNAEGFR wild-typeEffective targeted therapies
2024
Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline Update
Gordan J, Kennedy E, Abou-Alfa G, Beal E, Finn R, Gade T, Goff L, Gupta S, Guy J, Hoang H, Iyer R, Jaiyesimi I, Jhawer M, Karippot A, Kaseb A, Kelley R, Kortmansky J, Leaf A, Remak W, Sohal D, Taddei T, Wilson Woods A, Yarchoan M, Rose M. Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline Update. Journal Of Clinical Oncology 2024, 42: 1830-1850. PMID: 38502889, DOI: 10.1200/jco.23.02745.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsAdvanced hepatocellular carcinomaSecond-line therapyFirst-line treatmentRandomized Controlled TrialsHepatocellular carcinomaSystemic therapyFirst-lineChild-Pugh class A liver diseaseEastern Cooperative Oncology Group performance status 0Child-Pugh class A patientsSecond-line therapy optionsFirst-line settingPerformance status 0Third-line therapyFirst-line therapyClass A patientsEvidence-based guidelinesTolerated sorafenibStatus 0A patientsMechanism of actionTherapy optionsClinical decision-makingGuideline updateOral decitabine–cedazuridine versus intravenous decitabine for myelodysplastic syndromes and chronic myelomonocytic leukaemia (ASCERTAIN): a registrational, randomised, crossover, pharmacokinetics, phase 3 study
Garcia-Manero G, McCloskey J, Griffiths E, Yee K, Zeidan A, Al-Kali A, Deeg H, Patel P, Sabloff M, Keating M, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Kantarjian H, DeZern A, O'Connell C, Roboz G, Busque L, Buckstein R, Amin H, Randhawa J, Leber B, Shastri A, Dao K, Oganesian A, Hao Y, Keer H, Azab M, Savona M. Oral decitabine–cedazuridine versus intravenous decitabine for myelodysplastic syndromes and chronic myelomonocytic leukaemia (ASCERTAIN): a registrational, randomised, crossover, pharmacokinetics, phase 3 study. The Lancet Haematology 2024, 11: e15-e26. PMID: 38135371, DOI: 10.1016/s2352-3026(23)00338-1.Peer-Reviewed Original ResearchConceptsChronic myelomonocytic leukemiaIntravenous decitabineMyelodysplastic syndromeMyelomonocytic leukemiaOral therapyPrimary endpointAdverse eventsEastern Cooperative Oncology Group performance status 0Treatment cyclesCycle 1Full treatment dosePerformance status 0Treatment-related deathsFrequent adverse eventsSerious adverse eventsPhase 3 studyPhase 3 trialPotential treatment benefitsCommunity-based clinicsAcute myeloid leukemiaNext treatment cycleTreatment of individualsOral decitabineStatus 0Treatment discontinuation
2022
Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial
Watts J, Baer M, Yang J, Prebet T, Lee S, Schiller G, Dinner S, Pigneux A, Montesinos P, Wang E, Seiter K, Wei A, De Botton S, Arnan M, Donnellan W, Schwarer A, Récher C, Jonas B, Ferrell P, Marzac C, Kelly P, Sweeney J, Forsyth S, Guichard S, Brevard J, Henrick P, Mohamed H, Cortes J. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. The Lancet Haematology 2022, 10: e46-e58. PMID: 36370742, DOI: 10.1016/s2352-3026(22)00292-7.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaInhibitor of mutant isocitrate dehydrogenase 1Recommended phase 2 doseIDH1-mutated acute myeloid leukemiaPhase 2 doseDose-limiting toxicityCombination therapy groupMyeloid leukemiaCombination therapyMyelodysplastic syndromeClinical activityFebrile neutropeniaMonotherapy groupSmall-molecule inhibitor of mutant isocitrate dehydrogenase 1Eastern Cooperative Oncology Group performance status 0Treatment-emergent adverse eventsHigh-risk myelodysplastic syndromeRefractory acute myeloid leukemiaOpen-label clinical trialTherapy groupDose-escalation cohortsPerformance status 0Phase 1/2 studyTreatment-naive patientsPhase 1/2 trialA phase 1/2 study of the highly selective EGFR inhibitor, BLU-701, in patients with EGFR-mutant non–small cell lung cancer (NSCLC).
Spira A, Spigel D, Camidge D, De Langen A, Kim T, Goto K, Elamin Y, Shum E, Reckamp K, Rotow J, Goldberg S, Gadgeel S, Leal T, Albayya F, Fitzpatrick S, Louie-Gao M, Parepally J, Zalutskaya A, Yu H. A phase 1/2 study of the highly selective EGFR inhibitor, BLU-701, in patients with EGFR-mutant non–small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2022, 40: tps9142-tps9142. DOI: 10.1200/jco.2022.40.16_suppl.tps9142.Peer-Reviewed Original ResearchNon-small cell lung cancerEGFRm non-small cell lung cancerTyrosine kinase inhibitorsOverall response ratePrimary endpointEastern Cooperative Oncology Group performance status 0EGFR-mutant non-small cell lung cancerPhase 1 dose escalationPhase 2 primary endpointOral tyrosine kinase inhibitorGeneration tyrosine kinase inhibitorsResistance mutationsEGFR T790M mutationDisease control rateKey exclusion criteriaPerformance status 0Phase 1/2 studyPhase 2 doseProgression-free survivalPlatinum-based chemotherapyCell lung cancerDuration of responseCentral nervous system activityKey inclusion criteriaPK/pharmacodynamicsTROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PLT)-based regimens.
Grivas P, Pouessel D, Park C, Barthélémy P, Bupathi M, Petrylak D, Agarwal N, Flechon A, Ramamurthy C, Davis N, Recio-Boiles A, Tagawa S, Sternberg C, Bhatia A, Pichardo C, Goswami T, Loriot Y. TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PLT)-based regimens. Journal Of Clinical Oncology 2022, 40: 434-434. DOI: 10.1200/jco.2022.40.6_suppl.434.Peer-Reviewed Original ResearchObjective response rateTreatment-emergent adverse eventsMetastatic urothelial cancerInvestigator-assessed objective response ratePhase 2 trialProgression-free survivalSacituzumab govitecanCheckpoint inhibitorsEastern Cooperative Oncology Group performance status 0Most common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsSolid Tumors version 1.1Long-term disease controlBlinded independent central reviewAntigen 2 antibodiesClinical benefit rateECOG PS 1Manageable safety profileMedian overall survivalPerformance status 0Phase 2 doseTreatment-related AEsTreatment-related deathsTreatment-related gradeNew safety signalsTROPHY-U-01 cohort 4: Sacituzumab govitecan (SG) in combination with cisplatin (Cis) in platinum (PLT)-naïve patients (pts) with metastatic urothelial cancer (mUC).
Tagawa S, Grivas P, Petrylak D, Sternberg C, Swami U, Bhatia A, Pichardo C, Goswami T, Loriot Y. TROPHY-U-01 cohort 4: Sacituzumab govitecan (SG) in combination with cisplatin (Cis) in platinum (PLT)-naïve patients (pts) with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2022, 40: tps581-tps581. DOI: 10.1200/jco.2022.40.6_suppl.tps581.Peer-Reviewed Original ResearchMetastatic urothelial cancerBlinded independent central reviewObjective response rateSacituzumab govitecanOverall survivalDay 1Antibody-drug conjugatesCohort 4Eastern Cooperative Oncology Group performance status 0Prophylactic granulocyte colony-stimulating factorActive interstitial lung diseaseAntigen 2 antibodiesClinical benefit ratePerformance status 0Phase 2 doseStudy drug initiationMedian overall survivalProgression-free survivalPhase 2 trialDose-limiting toxicityInterstitial lung diseaseDuration of responseEfficacy/safetyGranulocyte colony-stimulating factorIndependent central reviewRandomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment
Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. CardioVascular And Interventional Radiology 2022, 45: 405-412. PMID: 35119481, PMCID: PMC8940827, DOI: 10.1007/s00270-021-03031-9.Peer-Reviewed Original ResearchConceptsBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseHepatocellular carcinomaCurative treatmentRECIST 1.1Primary endpointClinical benefitControl rateEastern Cooperative Oncology Group performance status 0Response rateChild-Pugh class ARandomized phase 3 studyDual primary endpointsOverall survival eventsPerformance status 0Previous systemic treatmentPD-1 inhibitorsPortal vein thrombosisPhase 3 studyResponse Evaluation CriteriaSolid Tumors 1.1
2021
Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Saboda K, Obara S, Chung C. Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2021, 39: 6015-6015. DOI: 10.1200/jco.2021.39.15_suppl.6015.Peer-Reviewed Original ResearchMedian progression-free survivalOverall response rateHepatocyte growth factorAdvanced HNSCCPartial responsePrimary endpointEvaluable subjectsHPV statusRecurrent/metastatic HNSCCAnti-EGFR monoclonal antibodiesNeck squamous cell carcinomaMajor prognostic variablesPerformance status 0Phase II trialProgression-free survivalNon-comparative trialsSquamous cell carcinomaConfidence intervalsPhase III investigationFC combinationDual pathway inhibitionLFT elevationsPFS endpointPrior cetuximabStatus 0A phase 1 dose-escalation study of intravenously (IV) administered TAK-676, a novel STING agonist, alone and in combination with pembrolizumab in patients (pts) with advanced or metastatic solid tumors.
Falchook G, Luke J, Strauss J, Gao X, LoRusso P, VOON P, Li C, Shaw M, Gregory R, Horn K, Gibbs J, Lineberry N, Stumpo K, Malek K, Olszanski A. A phase 1 dose-escalation study of intravenously (IV) administered TAK-676, a novel STING agonist, alone and in combination with pembrolizumab in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2021, 39: tps2670-tps2670. DOI: 10.1200/jco.2021.39.15_suppl.tps2670.Peer-Reviewed Original ResearchMetastatic solid tumorsCombination armCheckpoint inhibitorsSTING agonistsNovel STING agonistSolid tumorsDose escalationEastern Cooperative Oncology Group performance status 0Anti-programmed death ligand 1 therapyDay 1Phase 1 dose-escalation studyAnti-programmed death-1Death ligand 1 therapyPerformance status 0Phase 2 doseProinflammatory tumor environmentSolid Tumors (RECIST) v.Immune checkpoint inhibitorsDose-escalation studyResponse Evaluation CriteriaInnate immune cellsPreliminary antitumor activityStandard therapeutic optionAntitumor immune mechanismsImmuno-oncology therapiesSunitinib versus cabozantinib, crizotinib or savolitinib in metastatic papillary renal cell carcinoma (pRCC): Results from the randomized phase II SWOG 1500 study.
Pal S, Tangen C, Thompson I, Haas N, George D, Heng D, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason G, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara P. Sunitinib versus cabozantinib, crizotinib or savolitinib in metastatic papillary renal cell carcinoma (pRCC): Results from the randomized phase II SWOG 1500 study. Journal Of Clinical Oncology 2021, 39: 270-270. DOI: 10.1200/jco.2021.39.6_suppl.270.Peer-Reviewed Original ResearchMetastatic papillary renal cell carcinomaPapillary renal cell carcinomaProgression-free survivalMedian progression-free survivalEligible patientsPO QDPrior therapyOverall survivalAdverse eventsGrade 5 adverse eventsZubrod performance status 0Measurable metastatic diseasePerformance status 0Randomized phase IIRenal cell carcinomaMET kinase inhibitorType IMeaningful prolongationPo bidStatus 0Secondary endpointsMetastatic diseasePathologic reviewPFS eventsSystemic therapyPhase I study of AMG 509, a STEAP1 x CD3 T-cell recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Kelly W, Pook D, Appleman L, Waterhouse D, Horvath L, Edenfield W, Matsubara N, Danila D, Aggarwal R, Petrylak D, Sartor A, Sumey C, Adra N, Armstrong A, Cheng F, Stieglmaier J, Kouros-Mehr H, Dorff T. Phase I study of AMG 509, a STEAP1 x CD3 T-cell recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: tps183-tps183. DOI: 10.1200/jco.2021.39.6_suppl.tps183.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerFirst doseImmune therapyProstate cancerECOG performance status 0Prostate-specific antigen (PSA) responseCastration-resistant prostate cancerT cell-mediated lysisDose-expansion phasePerformance status 0Phase 2 doseObjective tumor responseT effector cellsASCO Annual MeetingTotal serum testosteroneLogistic regression modelsCell surface antigensTransmembrane epithelial antigenTumor cell responseCNS metastasisLeptomeningeal diseaseRECIST 1.1Status 0Taxane regimensHormonal therapy
2020
Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline.
Gordan JD, Kennedy EB, Abou-Alfa GK, Beg MS, Brower ST, Gade TP, Goff L, Gupta S, Guy J, Harris WP, Iyer R, Jaiyesimi I, Jhawer M, Karippot A, Kaseb AO, Kelley RK, Knox JJ, Kortmansky J, Leaf A, Remak WM, Shroff RT, Sohal DPS, Taddei TH, Venepalli NK, Wilson A, Zhu AX, Rose MG. Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline. Journal Of Clinical Oncology 2020, 38: 4317-4345. PMID: 33197225, DOI: 10.1200/jco.20.02672.Peer-Reviewed Original ResearchConceptsAdvanced hepatocellular carcinomaFirst-line treatmentSecond-line therapyChild-Pugh classFirst-line therapyHepatocellular carcinomaSystemic therapyLiver diseaseTherapy optionsEastern Cooperative Oncology Group performance status 0Evidence-based clinical practice guidelinesSecond-line therapy optionsTyrosine kinase inhibitor sorafenibECOG PS 0Performance status 0Third-line therapyPhase IIIClinical practice guidelinesKinase inhibitor sorafenibTyrosine kinase inhibitorsAppropriate candidatesStatus 0ASCO guidelinesMost patientsPS 0A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients with Previously Treated AL Amyloidosis (SWOG S1702; NCT#03499808)
Parker T, Rosenthal A, Sanchorawala V, Landau H, Campagnaro E, Kapoor P, Neparidze N, Hagen P, Sarosiek S, Scott E, Hoering A, Durie B, Usmani S, Orlowski R. A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients with Previously Treated AL Amyloidosis (SWOG S1702; NCT#03499808). Blood 2020, 136: 20-21. DOI: 10.1182/blood-2020-143180.Peer-Reviewed Original ResearchPhase II studyAL amyloidosisJanssen BiotechEligible patientsCardiac involvementII studyComplete responsePartial responseGrade IAnti-CD38 monoclonal antibody therapyCommon drug-related AEsECOG performance status 0Overall hematologic response rateAutologous stem cell transplantMonoclonal antibodiesAdvisory CommitteeDrug-related AEsHematologic response ratePerformance status 0Relapsed refractory myelomaGood partial responseHigh-dose therapyProgression-free survivalRefractory multiple myelomaStage III diseaseFrontline Bendamustine and Rituximab in Extranodal Marginal Zone Lymphoma: An International Analysis
Alderuccio J, Beaven A, Shouse G, Epperla N, Stefanovic A, Torka P, Castillo J, Argnani L, Voorhees T, Alpert A, Chowdhury S, Reis I, Zhao W, Edwards D, Martin P, Kamdar M, Herrera A, Friedberg J, Zinzani P, Lossos I. Frontline Bendamustine and Rituximab in Extranodal Marginal Zone Lymphoma: An International Analysis. Blood 2020, 136: 2-3. DOI: 10.1182/blood-2020-137620.Peer-Reviewed Original ResearchExtranodal marginal zone lymphomaEntity's Board of DirectorsIncidence of infectious complicationsMarginal zone lymphomaNo survival differenceRituximab maintenanceOverall survivalMALT-IPIInfectious complicationsSurvival differencesBone marrowPrognostic factors associated with worse outcomesADC therapeuticsIncidence of herpes zoster infectionECOG performance status 0Cases of acute myeloid leukemiaFactors associated with worse outcomesNon-gastric locationPerformance status 0ECOG performance statusGastric extranodal marginal zone lymphomaExpert pathology reviewHerpes zoster infectionMajority of patientsLog-rank testAbstract LB-387: Efficacy and safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in participants with metastatic colorectal cancer (mCRC): Initial results at the recommended dose for expansion (ARC-3)
Cecchini M, Modiano M, Braiteh F, Gardner O, Gilbert H, DiRenzo D, Seitz L, Walters M, Yin F, Woloski R, Paoloni M, Chung K. Abstract LB-387: Efficacy and safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in participants with metastatic colorectal cancer (mCRC): Initial results at the recommended dose for expansion (ARC-3). Cancer Research 2020, 80: lb-387-lb-387. DOI: 10.1158/1538-7445.am2020-lb-387.Peer-Reviewed Original ResearchModified FOLFOX-6Metastatic colorectal cancerAdverse eventsPhase 1bFOLFOX-6Stable diseaseColorectal cancerAnti-tumor immune responseECOG performance status 0Recommended doseAssociated with disease controlExploratory biomarker analysesTumor shrinkage >Disease control rateDying cancer cellsGrade 3 AEsPerformance status 0Dose-escalation studyAdenosine receptor blockadeOpen-label studyAmerican Association for Cancer ResearchAdenosine receptor antagonistRelease of ATPNext gene sequencingAdenosine axisPhase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer
Jabbour SK, Berman AT, Decker RH, Lin Y, Feigenberg SJ, Gettinger SN, Aggarwal C, Langer CJ, Simone CB, Bradley JD, Aisner J, Malhotra J. Phase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer. JAMA Oncology 2020, 6: 848-855. PMID: 32077891, PMCID: PMC7042914, DOI: 10.1001/jamaoncol.2019.6731.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarboplatinCarcinoma, Non-Small-Cell LungChemoradiotherapyFemaleHumansImmune Checkpoint InhibitorsLung NeoplasmsMaleMiddle AgedNeoplasm StagingPaclitaxelProgrammed Cell Death 1 ReceptorTreatment OutcomeConceptsNon-small cell lung cancerProgression-free survivalStage III non-small cell lung cancerMedian progression-free survivalDose of pembrolizumabSafety expansion cohortPD-1 inhibitionCell lung cancerExpansion cohortLung cancerDay 29Eastern Cooperative Oncology Group performance status 0Advanced non-small cell lung cancerDay 1Cell death 1 (PD-1) inhibitionDeath ligand 1 (PD-L1) inhibitionDose-limiting toxic effectDeath-1 (PD-1) inhibitionDoses of pembrolizumabGrade 5 pneumonitisLeast grade 4Performance status 0PD-1 inhibitorsPhase 1 trialLeast grade 3Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Siu L, Burtness B, Cohen E, Harrington K, Licitra L, Rischin D, Zhu Y, Lee C, Pinheiro C, Swaby R, Machiels J, Tahara M. Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6589-tps6589. DOI: 10.1200/jco.2020.38.15_suppl.tps6589.Peer-Reviewed Original ResearchBlinded independent central reviewCombined positive scoreFirst-line pembrolizumabM HNSCCDisease progressionRECIST v1.1PD-L1PD-L1 combined positive scoreECOG performance status 0PD-1 inhibitor pembrolizumabRecurrent/metastatic headEnd pointNeck squamous cell carcinomaCycles of pembrolizumabFirst-line monotherapyPerformance status 0Phase 1b/2 trialManageable safety profileObjective response ratePrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 statusPhase 3 studyProgression-free survivalSWOG S1400F (NCT03373760): A phase II study of durvalumab plus tremelimumab for previously treated patients with acquired resistance to PD-1 checkpoint inhibitor therapy and stage IV squamous cell lung cancer (Lung-MAP Sub-study).
Leighl N, Redman M, Rizvi N, Hirsch F, Mack P, Schwartz L, Wade J, Irvin W, Reddy S, Crawford J, Bradley J, Stinchcombe T, Ramalingam S, Miao J, Minichiello K, Gandara D, Herbst R, Papadimitrakopoulou V, Kelly K. SWOG S1400F (NCT03373760): A phase II study of durvalumab plus tremelimumab for previously treated patients with acquired resistance to PD-1 checkpoint inhibitor therapy and stage IV squamous cell lung cancer (Lung-MAP Sub-study). Journal Of Clinical Oncology 2020, 38: 9623-9623. DOI: 10.1200/jco.2020.38.15_suppl.9623.Peer-Reviewed Original ResearchSquamous lung carcinomaLung carcinomaMedian PFSAdverse eventsObjective responseDisease progressionStage IV squamous cell lung cancerPD-1 checkpoint inhibitor therapySquamous cell lung cancerPD-1 checkpoint inhibitorsGood responseAdequate organ functionGrade 4 dyspneaPerformance status 0PR/SDTreatment-related deathsCheckpoint inhibitor therapyImmune-related toxicitiesPhase II studyPD-1 inhibitionBest objective responseCell lung cancerEligible patientsQ28 daysStatus 0Phase I study of AMG 757, a half-life extended bispecific T-cell engager (HLE BiTE immune therapy) targeting DLL3, in patients with small cell lung cancer (SCLC).
Owonikoko T, Borghaei H, Champiat S, Paz-Ares L, Govindan R, Boyer M, Johnson M, Udagawa H, Hummel H, Salgia R, Blackhall F, Boosman R, Lai W, Dowlati A, Vokes E, Hann C, Chiang A, Endraca M, Soman N, Smit M. Phase I study of AMG 757, a half-life extended bispecific T-cell engager (HLE BiTE immune therapy) targeting DLL3, in patients with small cell lung cancer (SCLC). Journal Of Clinical Oncology 2020, 38: tps9080-tps9080. DOI: 10.1200/jco.2020.38.15_suppl.tps9080.Peer-Reviewed Original ResearchDelta-like ligand 3Small cell lung cancerImmune therapyT cellsRefractory small cell lung cancerECOG performance status 0PD-1 pathway inhibitorsPlatinum-based chemotherapy regimenBispecific T-cell engagersTumor cellsAdequate organ functionMost SCLC tumorsPerformance status 0Phase 2 doseSafety/tolerabilitySymptomatic brain metastasesAntitumor activityAggressive neuroendocrine tumorPhase 1 studyCancer cellsCell lung cancerPreliminary antitumor activityT-cell engagersDirect antitumor effectsPromising therapeutic target
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