2023
Characterization and Management of Cytopenias after Imetelstat Treatment in the IMerge Phase 3 Trial of Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Zeidan A, Savona M, Madanat Y, Fenaux P, Komrokji R, Jonášová A, Illmer T, Sun L, Berry T, Feller F, Navada S, Santini V, Platzbecker U. Characterization and Management of Cytopenias after Imetelstat Treatment in the IMerge Phase 3 Trial of Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS). Blood 2023, 142: 6478. DOI: 10.1182/blood-2023-180962.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsLower-risk myelodysplastic syndromesPhase 3 trialManagement of cytopeniasGrade 3Placebo groupDose adjustmentMedian timeTreatment delayDose reductionInternational Prognostic Scoring System risk groupsHematologic treatment-emergent adverse eventsRed blood cell transfusion dependencyImetelstat treatmentExperienced grade 3RBC transfusion burdenRBC transfusion independenceTreatment cycles 1Grade 4 neutropeniaGrade 4 thrombocytopeniaPrimary end pointGrowth factor supportErythropoiesis-stimulating agentsCycle 1High telomerase activity
2017
Nivolumab (N) plus ipilimumab (I) as first-line (1L) treatment for advanced (adv) NSCLC: 2-yr OS and long-term outcomes from CheckMate 012.
Goldman J, Antonia S, Gettinger S, Borghaei H, Brahmer J, Ready N, Gerber D, Chow L, Juergens R, Shepherd F, Laurie S, Geese W, Li A, Li X, Hellmann M. Nivolumab (N) plus ipilimumab (I) as first-line (1L) treatment for advanced (adv) NSCLC: 2-yr OS and long-term outcomes from CheckMate 012. Journal Of Clinical Oncology 2017, 35: 9093-9093. DOI: 10.1200/jco.2017.35.15_suppl.9093.Peer-Reviewed Original ResearchPD-L1 expressionComplete responsePD-L1Long-term OS benefitPD-L1 tumor expressionStage IIIB/IVTumor PD-L1 expressionChemotherapy-naive NSCLCECOG PS 0Experienced grade 3IIIB/IVManageable safety profileFirst-line treatmentPhase 1 studyLong-term survivorsLong-term outcomesMultiple tumor typesExploratory endpointsOS benefitAdvanced NSCLCPrimary endpointSecondary endpointsPS 0Unacceptable toxicityConsent withdrawalRamucirumab (R) plus pembrolizumab (P) in treatment naive and previously treated advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease phase I study.
Chau I, Bendell J, Calvo E, Santana-Davila R, Arkenau H, Mi G, Jin J, Rege J, Ferry D, Herbst R, Fuchs C. Ramucirumab (R) plus pembrolizumab (P) in treatment naive and previously treated advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease phase I study. Journal Of Clinical Oncology 2017, 35: 4046-4046. DOI: 10.1200/jco.2017.35.15_suppl.4046.Peer-Reviewed Original ResearchTreatment-related AEsDisease control rateECOG PSMedian durationMedian agePD-L1GEJ adenocarcinomaDay 1Phase 1a/b trialECOG PS 0Experienced grade 3Treatment-related deathsNew safety signalsPD-L1 statusOverall survival rateGastroesophageal junction adenocarcinomaPreliminary efficacy dataMeasurable diseaseMedian PFSAdvanced diseaseTreatment-naïveAdvanced gastricPS 0Junction adenocarcinomaCohort A
2007
A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303)
Lu C, Lee J, Komaki R, Herbst R, Evans W, Choy H, Desjardins P, Esparaz B, Truong M, Fisch M. A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303). Journal Of Clinical Oncology 2007, 25: 7527-7527. DOI: 10.1200/jco.2007.25.18_suppl.7527.Peer-Reviewed Original ResearchNon-small cell lung cancerStage III non-small cell lung cancerUnresectable stage III non-small cell lung cancerMedian survival timeConcomitant chemoradiotherapyInduction chemotherapyOverall survivalPerformance statusMedian age 63 yearsExperienced grade 3Site of enrollmentHigher adverse eventsPlacebo-controlled trialPhase III studyType of chemotherapyAge 63 yearsCell lung cancerShark cartilage extractMaintenance therapyMedian followPrimary endpointStage IIIBStudy drugAdverse eventsEligible subjects
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