2025
TROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR -mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC).
Lu S, Provencio M, Lisberg A, Mascarenhas E, Tanizaki J, Cheng Y, Kim H, Liu Y, Feng S, Zhang L, Toms L, Yang J, Goldberg S. TROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR -mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps8647.Peer-Reviewed Original ResearchProgression-free survivalSafety run-inCentral nervous systemEGFR mutationsPerformance statusSecondary endpointsPhase 3 clinical trial dataEGFR tyrosine kinase inhibitorsRun-inBlinded independent central reviewEGFR mutated NSCLCEGFR mutation typeDuration of responseWHO performance statusIndependent central reviewPhase 3 studyPrimary study endpointTyrosine kinase inhibitorsTopoisomerase I inhibitorAntibody-drug conjugatesMutated NSCLCAdvanced NSCLCIV diseaseNon-squamousOverall survivalPembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial
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, Retz M, Levesque E, McDermott R, Bracarda S, Manneh R, Levartovsky M, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial. Journal Of Clinical Oncology 2025, 43: 1638-1649. PMID: 40043230, PMCID: PMC12058370, DOI: 10.1200/jco-24-01283.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreat metastatic castration-resistant prostate cancerRadiographic progression-free survivalAndrogen receptor pathway inhibitorsCastration-resistant prostate cancerTreatment-related adverse eventsStandard of careAdverse eventsOverall survivalDouble-blindProstate cancerMedian radiographic progression-free survivalDual primary end pointsImmune-mediated adverse eventsEnd pointsBlinded independent central reviewData cutoff dateSafety of pembrolizumabAndrogen deprivation therapyProgression-free survivalIndependent central reviewSecondary end pointsPrimary end pointConcomitant prednisoneMedian OSDatopotamab deruxtecan (Dato-DXd) in locally advanced/metastatic urothelial cancer: Updated results from the phase 1 TROPIONPanTumor01 study.
Meric-Bernstam F, Alhalabi O, Lisberg A, Drakaki A, Garmezy B, Kogawa T, Spira A, Salkeni M, Gao X, Tolcher A, Bhave M, Doroshow D, Hoffman-Censits J, Klauss G, Kaga Y, Kakurai Y, Kojima T. Datopotamab deruxtecan (Dato-DXd) in locally advanced/metastatic urothelial cancer: Updated results from the phase 1 TROPIONPanTumor01 study. Journal Of Clinical Oncology 2025, 43: 663-663. DOI: 10.1200/jco.2025.43.5_suppl.663.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsBlinded independent central reviewProgression-free survivalDuration of responsePartial responseIndependent central reviewComplete responseConfirmed ORRUrothelial cancerCentral reviewMedian duration of responseMedian progression-free survivalResponse rateImmune checkpoint inhibitorsInterstitial lung disease/pneumonitisTreatment-related AEsMedian follow-upSolid tumor typesAntibody-drug conjugatesPrimary study objectiveCheckpoint inhibitorsDose interruptionPretreated ptsStable diseaseData cutoffCabozantinib (C) in combination with nivolumab (N) and ipilimumab (I) in previously untreated advanced renal cell carcinoma (aRCC): Final results of COSMIC-313.
Albiges L, Motzer R, Trevino S, Kanesvaran R, Centkowski P, Reimers M, Sade J, Pouessel D, Biscaldi E, Esteban E, Arranz Arija J, Tykodi S, Ma H, Zhou L, Van Kooten Losio M, Simmons A, Rangwala F, Braun D, Choueiri T, Powles T. Cabozantinib (C) in combination with nivolumab (N) and ipilimumab (I) in previously untreated advanced renal cell carcinoma (aRCC): Final results of COSMIC-313. Journal Of Clinical Oncology 2025, 43: 438-438. DOI: 10.1200/jco.2025.43.5_suppl.438.Peer-Reviewed Original ResearchAdvanced renal cell carcinomaPoor-risk advanced renal cell carcinomaTreatment-emergent AEPrimary endpointSecondary endpointsMacrophage abundanceUntreated advanced renal cell carcinomaPresence of visceral metastasesBlinded independent central reviewExploratory biomarker analysesIMDC risk groupsPD-L1 levelsBiomarker analysisIndependent central reviewEndpoint of OSFirst-line treatmentRenal cell carcinomaBaseline sumIMDC intermediateIMDC riskVisceral metastasesPD-L1ITT populationOS outcomesIncidence of PDFirst-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-lineNivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up results from CheckMate 649.
Janjigian Y, Moehler M, Ajani J, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary J, Elimova E, Bruges R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, McCraith S, Hu N, Zhang J, Shitara K. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up results from CheckMate 649. Journal Of Clinical Oncology 2025, 43: 398-398. DOI: 10.1200/jco.2025.43.4_suppl.398.Peer-Reviewed Original ResearchProgression-free survivalBlinded independent central reviewObjective response rateCombined positive scorePD-L1Overall survivalFollow-upCheckMate 649OS ratesPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Anti-PD-1Death-ligand 1Duration of responseIndependent central reviewMinimum follow-upFollow-up resultsLong-term survivalOS benefitCentral reviewCombination therapyFirst-linePrimary endpointNivolumabTransarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim J, Zhao H, Li C, Madoff D, Ghobrial R, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry A, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel A, Finn R, Llovet J, investigators L. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. The Lancet 2025, 405: 203-215. PMID: 39798578, DOI: 10.1016/s0140-6736(24)02575-3.Peer-Reviewed Original ResearchConceptsEastern Cooperative Oncology GroupNon-metastatic hepatocellular carcinomaProgression-free survivalTreatment-related adverse eventsPembrolizumab groupPhase 3 studyTransarterial chemoembolisationPlacebo groupHepatocellular carcinomaIntention-to-treatOverall survivalDouble-blindPerformance statusAdverse eventsFollow-upEastern Cooperative Oncology Group performance statusChild-Pugh class A diseaseMedian progression-free survivalSolid Tumors version 1.1Blinded independent central reviewA-fetoprotein levelAlbumin-bilirubin gradeResponse Evaluation CriteriaAs-treated populationMedian follow-up
2024
CTNI-54. RESPONSE BY RANO2.0 CRITERIA IN ONC201 (DORDAVIPRONE)-TREATED PATIENTS WITH RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA
Cloughesy T, Allen J, Arrillaga-Romany I, Barbaro M, Batchelor T, Butowski N, Cluster A, de Groot J, Graber J, Haggiagi A, Kilburn L, Kurz S, Melemed A, Ramage S, Salacz M, Shonka N, Sumrall A, Tarapore R, Taylor L, Wen P. CTNI-54. RESPONSE BY RANO2.0 CRITERIA IN ONC201 (DORDAVIPRONE)-TREATED PATIENTS WITH RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA. Neuro-Oncology 2024, 26: viii109-viii109. PMCID: PMC11552873, DOI: 10.1093/neuonc/noae165.0421.Peer-Reviewed Original ResearchDiffuse midline gliomaH3 K27M-mutant diffuse midline gliomaH3K27M-mutant diffuse midline gliomaMidline gliomaResponse assessmentTarget lesionsMedian duration of responseMedian time to responseProgression free survival rateDiffuse intrinsic pontine gliomaBlinded independent central reviewAssociated with overall survivalNon-enhancing diseaseDisease control ratePrimary spinal tumorsDuration of responseFree survival rateIntrinsic pontine gliomaImproved performance statusIndependent central reviewClinically meaningful efficacyTime to responseOverall response rateAnti-cancer therapyComplete responseA pooled analysis of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with brain metastases
André F, Cortés J, Curigliano G, Modi S, Li W, Park Y, Chung W, Kim S, Yamashita T, Pedrini J, Im S, Tseng L, Harbeck N, Krop I, Nakatani S, Tecson K, Ashfaque S, Egorov A, Hurvitz S. A pooled analysis of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with brain metastases. Annals Of Oncology 2024, 35: 1169-1180. PMID: 39241960, DOI: 10.1016/j.annonc.2024.08.2347.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerBlinded independent central reviewMetastatic breast cancerBrain metastasesT-DXdOverall survivalCNS-PFSTrastuzumab deruxtecanBreast cancerCentral nervous system progression-free survivalIntracranial responsePooled analysisIntracranial objective response rateSafety of trastuzumab deruxtecanSystemic progression-free survivalObjective response rateORR of patientsProgression-free survivalDuration of responseFood and Drug Administration criteriaIndependent central reviewUS Food and Drug Administration criteriaCompare treatmentsExploratory pooled analysisBM statusPembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial
Dzienis M, Cundom J, Fuentes C, Spreafico A, Nordlinger M, Pastor A, Alesi E, Neki A, Fung A, Lima I, Oppelt P, da Cunha G, Burtness B, Franke F, Tseng J, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. Journal Of Clinical Oncology 2024, 42: 2989-2999. PMID: 39038265, PMCID: PMC11361359, DOI: 10.1200/jco.23.02625.Peer-Reviewed Original ResearchBlinded independent central reviewRecurrent/metastatic head and neck squamous cell carcinomaHead and neck squamous cell carcinomaNeck squamous cell carcinomaR/M HNSCCSquamous cell carcinomaRECIST v1.1Cell carcinomaSingle-armStandard-of-care first-line treatmentSafety of first-line pembrolizumabEastern Cooperative Oncology Group performance statusDay 1Treatment-related adverse eventsAlternative chemotherapy combinationsFirst-line pembrolizumabPD-L1 statusMedian follow-upFirst-line therapyIndependent central reviewFirst-line treatmentPhase IV trialChemotherapy combinationsComplete responsePD-L1Nivolumab (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 reviewA phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2.
Loriot Y, Siefker-Radtke A, Friedlander T, Necchi A, Wei A, Sridhar S, Garmezy B, Arroyo S, Gartside E, Liu J, Campbell C, Bader J, Petrylak D. A phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2. Journal Of Clinical Oncology 2024, 42: tps4619-tps4619. DOI: 10.1200/jco.2024.42.16_suppl.tps4619.Peer-Reviewed Original ResearchUrothelial cancerMonomethyl auristatin ECohort 2Cohort 1Nectin-4Optimal doseExposure to normal tissuesInterim analysisBlinded independent central reviewMetastatic urothelial cancerObjective response ratePenetrate solid tumorsAdequate organ functionDisease control rateProgression-free survivalPlatinum-based chemotherapyDuration of responseECOG performance statusPreliminary antitumor activityIndependent central reviewPlasma half-lifeWeeks follow-upMetastatic UCRECIST v1.1Enfortumab vedotinTrastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial
Fehm T, Cottone F, Dunton K, André F, Krop I, Park Y, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego M, Yerushalmi R, Duhoux F, Takano T, Lu W, Egorov A, Kim S. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. The Lancet Oncology 2024, 25: 614-625. PMID: 38697155, DOI: 10.1016/s1470-2045(24)00128-1.Peer-Reviewed Original ResearchConceptsTreatment of physician's choiceMetastatic breast cancerTreatment of physician's choice groupPatient-reported outcomesPhysician's choice groupTrastuzumab deruxtecan groupTrastuzumab deruxtecanPhase 3 trialHER2-positiveBreast cancerGlobal health statusPhysician's choiceEORTC QLQ-C30 global health statusPatient-reported outcome variablesOpen-labelQLQ-C30 global health statusTrastuzumab emtansineDefinitive deteriorationMedian time to definitive deteriorationHER2-positive metastatic breast cancerEastern Cooperative Oncology Group performance statusTreatment durationBlinded independent central reviewQuality of lifeProgression-free survivalDatopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study
Bardia A, Krop I, Kogawa T, Juric D, Tolcher A, Hamilton E, Mukohara T, Lisberg A, Shimizu T, Spira A, Tsurutani J, Damodaran S, Papadopoulos K, Greenberg J, Kobayashi F, Zebger-Gong H, Wong R, Kawasaki Y, Nakamura T, Meric-Bernstam F. Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2– and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study. Journal Of Clinical Oncology 2024, 42: 2281-2294. PMID: 38652877, PMCID: PMC11210948, DOI: 10.1200/jco.23.01909.Peer-Reviewed Original ResearchTriple-negative BCHR+/HER2- BCBreast cancerHormone receptor-positive/human epidermal growth factor receptor 2-negativeAll-causality treatment-emergent adverse eventsMedian duration of responseTopoisomerase I inhibitor payloadTreatment-emergent adverse eventsBlinded independent central reviewTriple-negative breast cancerDose-expansion studyProgression-free survivalDuration of responsePhase III studyIndependent central reviewTreating solid tumorsPrimary study objectiveAntibody-drug conjugatesDose escalationData cutoffTriple-negativeBC cohortEvaluation of antitumor activityIII studiesMedian durationONC201 (Dordaviprone) in Recurrent H3 K27M–Mutant Diffuse Midline Glioma
Arrillaga-Romany I, Gardner S, Odia Y, Aguilera D, Allen J, Batchelor T, Butowski N, Chen C, Cloughesy T, Cluster A, de Groot J, Dixit K, Graber J, Haggiagi A, Harrison R, Kheradpour A, Kilburn L, Kurz S, Lu G, MacDonald T, Mehta M, Melemed A, Nghiemphu P, Ramage S, Shonka N, Sumrall A, Tarapore R, Taylor L, Umemura Y, Wen P. ONC201 (Dordaviprone) in Recurrent H3 K27M–Mutant Diffuse Midline Glioma. Journal Of Clinical Oncology 2024, 42: 1542-1552. PMID: 38335473, PMCID: PMC11095894, DOI: 10.1200/jco.23.01134.Peer-Reviewed Original ResearchConceptsH3 K27M-mutant diffuse midline gliomaDiffuse midline gliomaDuration of responseTime to responseHigh-grade gliomasLow-grade gliomasMidline gliomaMedian duration of responseMedian time to responseTreatment-emergent adverse eventsEnd pointsBlinded independent central reviewCorticosteroid dose reductionIndependent central reviewSecondary end pointsClinically meaningful efficacyRadiographic end pointsSpinal tumorsDose reductionDismal prognosisCentral reviewPerformance scoresCorticosteroid responseResponse assessmentAdverse eventsNivolumab (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
Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
O'Donnell P, Milowsky M, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, Friedlander T, McKay R, Bilen M, Srinivas S, Burgess E, Ramamurthy C, George S, Geynisman D, Bracarda S, Borchiellini D, Geoffrois L, Rey J, Ferrario C, Carret A, Yu Y, Guseva M, Moreno B, Rosenberg J. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. Journal Of Clinical Oncology 2023, 41: 4107-4117. PMID: 37369081, PMCID: PMC10852367, DOI: 10.1200/jco.22.02887.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCisplatin-ineligible patientsDuration of responseMetastatic urothelial cancerUrothelial cancerAdverse eventsHigher treatment-related adverse eventsPhase Ib/II studyMedian DORFirst-line treatment optionEnd pointBlinded independent central reviewCommon grade 3Objective response ratePrimary end pointSecondary end pointsNew safety signalsCisplatin-based therapyIndependent central reviewUntreated LACombination armDurable responsesII studyMaculopapular rashSurvival benefitEnfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data.
Friedlander T, Milowsky M, O'Donnell P, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, McKay R, Bilen M, Borchiellini D, Iafolla M, Carret A, Yu Y, Guseva M, Kataria R, Rosenberg J. Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data. Journal Of Clinical Oncology 2023, 41: 4568-4568. DOI: 10.1200/jco.2023.41.16_suppl.4568.Peer-Reviewed Original ResearchProgression-free survivalDisease control rateDuration of responseMedian DORMedian progression-free survivalBlinded independent central reviewOverall survivalPFS rateAdverse eventsOS ratesSkin reactionsTreatment-emergent adverse eventsTreatment-related adverse eventsFirst-line treatment optionManageable safety profileObjective response ratePD-1 inhibitorsMetastatic urothelial cancerSevere skin reactionsIndependent central reviewNew safety concernsHigh unmet needImmunogenic cell deathRECIST v1.1Primary endpointInitial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC).
Banerjee S, Ring K, Van Nieuwenhuysen E, Fabbro M, Aghajanian C, Oaknin A, Colombo N, Santin A, Clamp A, Moore K, Rose P, O'Malley D, Chon H, Salinas E, Prendergast E, Lustgarten S, Rodrigues M, Gennigens C, Monk B, Grisham R. Initial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC). Journal Of Clinical Oncology 2023, 41: 5515-5515. DOI: 10.1200/jco.2023.41.16_suppl.5515.Peer-Reviewed Original ResearchRecurrent low-grade serous ovarian cancerLow-grade serous ovarian cancerOptimal regimenPartial responseKRAS statusOvarian cancerHigher disease control rateMost AEsMEK inhibitorsBlinded independent central reviewRAF/MEK inhibitionDisease control ratePrior systemic regimensSimilar AE profilesNew safety signalsPhase 2 studyIndependent central reviewKey inclusion criteriaSerous ovarian cancerSynergistic antitumor activityMajority of treatmentsDermatitis acneiformEvaluable patientsCombination armSystemic regimens
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