2025
First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up of Chinese pts from CheckMate 649.
Shen L, Bai Y, Lin X, Li W, Wang J, Zhang X, Pan H, Bai C, Bai L, Cheng Y, Zhang J, Zhong H, Ba Y, Hu W, Xu R, Guo W, Qin S, Hu N, McCraith S, Liu T. First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up of Chinese pts from CheckMate 649. Journal Of Clinical Oncology 2025, 43: 392-392. DOI: 10.1200/jco.2025.43.4_suppl.392.Peer-Reviewed Original ResearchBlinded independent central reviewObjective response rateProgression-free survivalCombined positive scorePD-L1CheckMate 649Overall survivalFollow-upSurvival benefitPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Long-term survival benefitStudy populationDual primary endpointsDeath-ligand 1Gastroesophageal junction cancerDuration of responseAdvanced gastric cancerIndependent central reviewOS ratesJunction cancerCentral reviewPrimary endpointFirst-line
2024
Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649.
Elimova E, Shitara K, Moehler M, Ajani J, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary J, Bruges Maya R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Feeney K, Wang R, Nathani R, Janjigian Y. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649. Journal Of Clinical Oncology 2024, 42: 4040-4040. DOI: 10.1200/jco.2024.42.16_suppl.4040.Peer-Reviewed Original ResearchProgression-free survivalBlinded independent central reviewCombined positive scoreObjective response ratePD-L1Overall survivalFollow-upCheckMate 649Clinically meaningful progression-free survivalPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Dual primary endpointsHER2+ patientsDeath-ligand 1Analysis of OSIndependent central reviewLong-term efficacyFollow-up resultsEarly Follow-upClinically Meaningful ImprovementsMedian OSOS benefitPD-1Central reviewFruquintinib plus paclitaxel versus paclitaxel as second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma (FRUTIGA): A randomized, multicenter, double-blind, placebo-controlled, phase 3 study.
Xu R, Wang F, Shen L, Guo W, Liu T, Li J, Qin S, Bai Y, Chen Z, Wang J, Pan Y, Shu Y, Zhao F, Cheng Y, Ye F, Gu K, Zhang T, Pan H, Zhong H, Su W. Fruquintinib plus paclitaxel versus paclitaxel as second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma (FRUTIGA): A randomized, multicenter, double-blind, placebo-controlled, phase 3 study. Journal Of Clinical Oncology 2024, 42: 438780-438780. DOI: 10.1200/jco.2024.42.36_suppl.438780.Peer-Reviewed Original ResearchPhase 3 studyAntitumor therapyMedian OSDouble-blindPrimary endpointInhibitor of VEGFR-1Dose of study drugSecond-line treatment optionDual primary endpointsPlacebo (PBO)-controlledFirst-line chemotherapyGastroesophageal junction adenocarcinomaMetastatic colorectal cancerSecond-line therapyLymph node metastasisTreatment of paclitaxelStatistical significanceCox proportional hazards modelsPost Hoc AnalysisOral inhibitorJunction adenocarcinomaEligible ptsPlacebo-ControlledStudy drugStatistically significant improvementNivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649.
Shitara K, Moehler M, Ajani J, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary J, Elimova E, Bruges Maya R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Feeney K, Wang R, Nathani R, Janjigian Y. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649. Journal Of Clinical Oncology 2024, 42: 306-306. DOI: 10.1200/jco.2024.42.3_suppl.306.Peer-Reviewed Original ResearchProgression-free survivalBlinded independent central reviewCombined positive scoreObjective response ratePD-L1Overall survivalFollow-upCheckMate 649Clinically meaningful progression-free survivalPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Dual primary endpointsHER2+ patientsDeath-ligand 1Analysis of OSIndependent central reviewLong-term efficacyFollow-up resultsEarly Follow-upClinically Meaningful ImprovementsMedian OSOS benefitPD-1Central reviewFirst-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 Chinese subgroup analysis 4-year (yr) follow-up.
Shen L, Bai Y, Lin X, Li W, Wang J, Zhang X, Pan H, Bai C, Bai L, Cheng Y, Zhang J, Zhong H, Ba Y, Hu W, Xu R, Guo W, Qin S, Wang R, McCraith S, Liu T. First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 Chinese subgroup analysis 4-year (yr) follow-up. Journal Of Clinical Oncology 2024, 42: 318-318. DOI: 10.1200/jco.2024.42.3_suppl.318.Peer-Reviewed Original ResearchBlinded independent central reviewProgression-free survivalCombined positive scorePD-L1Overall survivalFollow-upCheckMate 649Safety profilePD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Clinically meaningful survival benefitStudy populationDual primary endpointsObjective response rateDeath-ligand 1Gastroesophageal junction cancerYrs of follow-upAdvanced gastric cancerIndependent central reviewOS ratesJunction cancerSurvival benefitCentral reviewFirst-line
2023
A phase 2/3 trial in progress on tebentafusp as monotherapy and in combination with pembrolizumab in HLA-A*02:01+ patients with previously treated advanced non-uveal melanoma (TEBE-AM).
Davar D, Ikeguchi A, Buchbinder E, Shoushtari A, Seedor R, Bernicker E, Weiss S, Daniels G, Panella T, Ryan H, Goodall H, Sullivan R. A phase 2/3 trial in progress on tebentafusp as monotherapy and in combination with pembrolizumab in HLA-A*02:01+ patients with previously treated advanced non-uveal melanoma (TEBE-AM). Journal Of Clinical Oncology 2023, 41: tps9594-tps9594. DOI: 10.1200/jco.2023.41.16_suppl.tps9594.Peer-Reviewed Original ResearchMetastatic cutaneous melanomaMetastatic uveal melanomaAdvanced melanomaInvestigator's choicePrimary endpointDual primary endpointsOverall survival benefitPhase 3 trialSimilar patient populationsPhase 2/3 trialIC armOS benefitPrior ipilimumabRECIST responseInhibitor regimenSupportive careSurvival benefitCare therapyAnti-CTLA4CtDNA levelsTumor burdenInvestigational agentsPatient populationCutaneous melanomaClinical trialsPembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study.
Petrylak D, Ratta R, Matsubara N, Korbenfeld E, Gafanov R, Mourey L, Todenhöfer T, Gurney H, Kramer G, Bergman A, Zalewski P, De Santis M, Armstrong A, Gerritsen W, Pachynski R, Byun S, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study. Journal Of Clinical Oncology 2023, 41: 19-19. DOI: 10.1200/jco.2023.41.6_suppl.19.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerNext-generation hormonal agentsDual primary endpointsTreatment-related AEsCycles of docetaxelPrimary endpointSecondary endpointsDocetaxel armRadiographic progression-free survivalCastration-resistant prostate cancerBlinded independent central reviewCycles of placeboData cutoff dateSafety of pembrolizumabSubsequent anticancer therapyTreatment-related deathsAndrogen deprivation therapyECOG performance statusKey secondary endpointProgression-free survivalIndependent central reviewEligible ptsDeprivation therapyRECIST 1.1Baseline characteristics
2022
Event-free survival by residual cancer burden after neoadjuvant pembrolizumab + chemotherapy versus placebo + chemotherapy for early TNBC: Exploratory analysis from KEYNOTE-522.
Pusztai L, Denkert C, O'Shaughnessy J, Cortes J, Dent R, McArthur H, Kuemmel S, Bergh J, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Zhu Y, Pan W, Tryfonidis K, Schmid P. Event-free survival by residual cancer burden after neoadjuvant pembrolizumab + chemotherapy versus placebo + chemotherapy for early TNBC: Exploratory analysis from KEYNOTE-522. Journal Of Clinical Oncology 2022, 40: 503-503. DOI: 10.1200/jco.2022.40.16_suppl.503.Peer-Reviewed Original ResearchRandomized 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
CTIM-25. A RANDOMIZED PHASE 3 STUDY OF NIVOLUMAB OR PLACEBO COMBINED WITH RADIOTHERAPY PLUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA WITH METHYLATED MGMT PROMOTER: CHECKMATE 548
Weller M, Lim M, Idbaih A, Steinbach J, Finocchiaro G, Raval R, Ashby L, Ansstas G, Baehring J, Taylor J, Honnorat J, Petrecca K, de Vos F, Wick A, Sumrall A, Roberts M, Slepetis R, Warad D, Lee M, Reardon D, Omuro A. CTIM-25. A RANDOMIZED PHASE 3 STUDY OF NIVOLUMAB OR PLACEBO COMBINED WITH RADIOTHERAPY PLUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA WITH METHYLATED MGMT PROMOTER: CHECKMATE 548. Neuro-Oncology 2021, 23: vi55-vi56. PMCID: PMC8598415, DOI: 10.1093/neuonc/noab196.217.Peer-Reviewed Original ResearchProgression-free survivalMedian overall survivalPhase 3 studyOverall survivalMGMT promoterBaseline corticosteroidsMedian progression-free survivalTreatment-related adverse eventsRandomized phase 3 studyTumor PD-L1 expressionBlinded independent central reviewDual primary endpointsRole of immunotherapyNew safety signalsPD-L1 expressionPositive prognostic factorIndependent central reviewPredictors of benefitCare radiotherapyTreatment landscapeAdverse eventsPrognostic factorsCentral reviewNivolumabNovel therapies
2019
LBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC)
Schmid P, Cortés J, Dent R, Pusztai L, McArthur H, Kuemmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching P, Cardoso F, Jia L, Karantza V, Zhao J, Aktan G, O’Shaughnessy J. LBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC). Annals Of Oncology 2019, 30: v853-v854. DOI: 10.1093/annonc/mdz394.003.Peer-Reviewed Original ResearchEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalSubsidiary of MerckGerman Study GroupBristol-Myers SquibbPD-L1Dohme Corp.Daiichi SankyoSeattle GeneticsChemo groupYpT0 ypN0Merck SharpGenomic HealthStudy groupFavorable trendF. Hoffmann-La Roche LtdCycles of paclitaxelDual primary endpointsI-SPY 2Cycles of doxorubicinPhase III studyWolters Kluwer HealthEli LillyKyowa Hakko Kirin
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