2020
Ramucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial
Chau I, Penel N, Soriano AO, Arkenau HT, Cultrera J, Santana-Davila R, Calvo E, Le Tourneau C, Zender L, Bendell JC, Mi G, Gao L, McNeely SC, Oliveira JM, Ferry D, Herbst RS, Fuchs CS. Ramucirumab in Combination with Pembrolizumab in Treatment-Naïve Advanced Gastric or GEJ Adenocarcinoma: Safety and Antitumor Activity from the Phase 1a/b JVDF Trial. Cancers 2020, 12: 2985. PMID: 33076423, PMCID: PMC7602637, DOI: 10.3390/cancers12102985.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalOverall survivalPD-L1GEJ cancerGrade 3 treatment-related adverse eventsTreatment-related adverse eventsAlanine/aspartate aminotransferaseDurable clinical activityFirst-line patientsPrior systemic chemotherapyAntitumor activityDuration of responseSpectrum of patientsStudy design limitationsCheckpoint inhibitorsMetastatic settingPrimary endpointSecondary endpointsSystemic chemotherapyTreatment-naïveAdvanced gastricAdverse eventsAdvanced cancerPositive tumors
2019
Phase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753).
Waqar S, Redman M, Arnold S, Hirsch F, Mack P, Schwartz L, Gandara D, Stinchcombe T, Leighl N, Ramalingam S, Tanna S, Raddin R, Minichiello K, Kelly K, Bradley J, Herbst R, Papadimitrakopoulou V. Phase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753). Journal Of Clinical Oncology 2019, 37: 9075-9075. DOI: 10.1200/jco.2019.37.15_suppl.9075.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCohort 1Interim analysisLung squamous cell cancerAdequate organ functionDisease control rateMedian overall survivalPhase II studySquamous cell cancerDuration of responseEvaluable patientsG3 eventsImmunotherapy exposureRECIST 1.1Stable diseasePrimary endpointSecondary endpointsUnacceptable toxicityAdverse eventsII studyHepatic involvementCell cancerPositive tumorsControl rate