2020
DKN-01 in combination with pembrolizumab in patients with advanced gastroesophageal adenocarcinoma (GEA): Tumoral DKK1 expression as a predictor of response and survival.
Klempner S, Bendell J, Villaflor V, Tenner L, Stein S, Naik G, Sirard C, Kagey M, Chaney M, Strickler J. DKN-01 in combination with pembrolizumab in patients with advanced gastroesophageal adenocarcinoma (GEA): Tumoral DKK1 expression as a predictor of response and survival. Journal Of Clinical Oncology 2020, 38: 357-357. DOI: 10.1200/jco.2020.38.4_suppl.357.Peer-Reviewed Original ResearchProgression-free survivalDisease control rateObjective response ratePD-L1 expressionAdvanced gastroesophageal adenocarcinomaGastroesophageal adenocarcinomaDKN-01Overall survivalDKK1 expressionGEA patientsMedian progression-free survivalImmune-suppressive tumor microenvironmentPhase 1b/2a studyKaplan-Meier methodSuppressive tumor microenvironmentPotential predictive biomarkersPredictors of responseDKK1 mRNA expressionDKK1 antibodyMedian OSFree survivalClinical benefitSurvival outcomesControl ratePredictive biomarkers
2019
LBA39 Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC)
Lee M, Ryoo B, Hsu C, Numata K, Stein S, Verret W, Hack S, Spahn J, Liu B, Abdullah H, He R, Lee K. LBA39 Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC). Annals Of Oncology 2019, 30: v875. DOI: 10.1093/annonc/mdz394.030.Peer-Reviewed Original ResearchGenentech/RocheUnresectable hepatocellular carcinomaHepatocellular carcinomaMedian PFSPrimary endpointArm AF. Hoffmann-La RocheComplete responsePartial responseHoffmann-La RocheOno PharmaceuticalDisease control rateIndependent review facilityObjective response rateTolerable safety profileProgression-free survivalDuration of responseEli LillyMedical writing assistanceGr 3Bristol-Myers SquibbEisai Inc.Improved PFSMedian DoRRECIST 1.1A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC).
Cecchini M, Kortmansky J, Lacy J, Fischbach N, Thumar J, Sabbath K, Gomez C, Sporn J, Stein S, Hochster H. A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2019, 37: 630-630. DOI: 10.1200/jco.2019.37.4_suppl.630.Peer-Reviewed Original ResearchDisease control rateMetastatic colorectal cancerTAS-102Progressive diseaseDay 1Thymidine phosphorylase inhibitorRefractory metastatic colorectal cancerDose-escalating studyECOG PS 0Phase II doseEfficacy of oxaliplatinUsual laboratory parametersEligible patientsEvaluable patientsMeasurable diseaseUnexpected AEsStarting doseTreatment discontinuationPS 0Improved survivalLaboratory parametersOral combinationColorectal cancerPatient populationControl rate
2017
Phase I study combining the aurora kinase A (AURKA) inhibitor alisertib (Ali) with mFOLFOX in gastrointestinal (GI) cancer.
Goff L, Azad N, Stein S, Whisenant J, Vaishampayan U, Hochster H, Connolly R, Weise A, LoRusso P, El-Rifai W, Berlin J. Phase I study combining the aurora kinase A (AURKA) inhibitor alisertib (Ali) with mFOLFOX in gastrointestinal (GI) cancer. Journal Of Clinical Oncology 2017, 35: 2593-2593. DOI: 10.1200/jco.2017.35.15_suppl.2593.Peer-Reviewed Original ResearchGI cancersStandard platinum-based therapyCorrelative biomarker studyDisease control rateMost frequent toxicitiesPreliminary clinical activityPlatinum-based therapyMajority of ptsEvaluable ptsStable diseaseEligible patientsFrequent toxicitiesHematologic toxicityPartial responseStandard therapyDose escalationInhibition of AURKAControl rateGastrointestinal cancerPreclinical dataClinical activityPlatinum agentsDose levelsInhibitor alisertibOptimal timing windowA phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients (pts) for first-line therapy with advanced biliary tract cancer (BTC).
Eads J, Stein S, El-Khoueiry A, Manji G, Abrams T, Khorana A, Miksad R, Mahalingam D, Sirard C, Zhu A, Goyal L. A phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients (pts) for first-line therapy with advanced biliary tract cancer (BTC). Journal Of Clinical Oncology 2017, 35: 4075-4075. DOI: 10.1200/jco.2017.35.15_suppl.4075.Peer-Reviewed Original ResearchBiliary tract cancerAdvanced biliary tract cancerTreatment-emergent adverse eventsAdverse eventsPartial responseGrade 3/4 treatment-emergent adverse eventsAST/ALT elevationMonoclonal antibodiesDisease control rateEmergent adverse eventsMedian overall survivalFirst-line therapySerious adverse eventsDuration of responseHumanized monoclonal antibodyVEGF-C expressionInhibits cell invasionPromoter of metastasisDKN-01Median PFSALT elevationPrior regimensStable diseaseMedian durationProgressive disease