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
2018
Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open‐Label, Phase I Trial (JVDF)
Arkenau H, Martin‐Liberal J, Calvo E, Penel N, Krebs MG, Herbst RS, Walgren RA, Widau RC, Mi G, Jin J, Ferry D, Chau I. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open‐Label, Phase I Trial (JVDF). The Oncologist 2018, 23: 1407-e136. PMID: 29853658, PMCID: PMC6292555, DOI: 10.1634/theoncologist.2018-0044.Peer-Reviewed Original ResearchConceptsMetastatic biliary tract cancerTreatment-related adverse eventsBiliary tract cancerObjective response rateProgression-free survivalOverall survivalTract cancerCommon grade 3 treatment-related adverse eventsGrade 3 treatment-related adverse eventsGrade 4 treatment-related adverse eventsDay 1Response rateAdvanced biliary tract cancerMedian progression-free survivalBiomarker-unselected patientsEfficacy of ramucirumabInfrequent grade 3Limited clinical activityPD-1 antagonistsTreatment-related deathsUnexpected safety findingsVEGFR-2 antagonistGrowth factor receptor 2Phase I trialExtrahepatic bile ductSafety and antitumor activity of ramucirumab plus pembrolizumab in treatment naïve advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Preliminary results from a multi-disease phase I study (JVDF).
Chau I, Penel N, Arkenau H, Santana-Davila R, Calvo E, Soriano A, Mi G, Jin J, Ferry D, Herbst R, Fuchs C. Safety and antitumor activity of ramucirumab plus pembrolizumab in treatment naïve advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Preliminary results from a multi-disease phase I study (JVDF). Journal Of Clinical Oncology 2018, 36: 101-101. DOI: 10.1200/jco.2018.36.4_suppl.101.Peer-Reviewed Original ResearchTreatment-related adverse eventsGEJ adenocarcinomaMedian durationPD-L1Study treatmentPreliminary efficacyGrade 3 treatment-related adverse eventsGrade 4 treatment-related adverse eventsDay 1Grade treatment-related adverse eventsPhase 1a/b trialMedian progression-free survivalCell death 1 proteinAntitumor activityDisease control rateECOG PS 0Median overall survivalMedian treatment durationPD-L1 statusProgression-free survivalGrowth factor receptor 2Gastroesophageal junction adenocarcinomaDeath 1 proteinBaseline tumor tissueEndothelial growth factor receptor 2
2017
A phase II study of palbociclib (P) for previously treated cell cycle gene alteration positive patients (pts) with stage IV squamous cell lung cancer (SCC): Lung-MAP sub-study SWOG S1400C.
Edelman M, Redman M, Albain K, McGary E, Rafique N, Petro D, Waqar S, Miao J, Griffin K, Papadimitrakopoulou V, Kelly K, Gandara D, Herbst R. A phase II study of palbociclib (P) for previously treated cell cycle gene alteration positive patients (pts) with stage IV squamous cell lung cancer (SCC): Lung-MAP sub-study SWOG S1400C. Journal Of Clinical Oncology 2017, 35: 9056-9056. DOI: 10.1200/jco.2017.35.15_suppl.9056.Peer-Reviewed Original ResearchStage IV squamous cell lung cancerDisease control rateAdverse eventsResponse rateCCND1 amplificationGrade 3 treatment-related adverse eventsPhase II/III trialsCell cycle gene alterationsPrior platinum-based chemotherapyGrade 4 adverse eventsTreatment-related adverse eventsSquamous cell lung cancerGene alterationsPhase II studyPhase II trialPlatinum-based chemotherapyCDK 4/6 inhibitorsCell lung cancerNormal organ functionMedian PFSPrimary endpointII studyII trialIII trialsPositive patients