2022
Phase 3, multicenter, randomized study of CPI-613 with modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) as first-line therapy for patients with metastatic adenocarcinoma of the pancreas (AVENGER500).
Philip P, Bahary N, Mahipal A, Kasi A, Lima C, Alistar A, Oberstein P, Golan T, Sahai V, Metges J, Lacy J, Fountzilas C, Lopez C, Ducreux M, Hammel P, Salem M, Bajor D, Benson A, Buyse M, Van Cutsem E. Phase 3, multicenter, randomized study of CPI-613 with modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) as first-line therapy for patients with metastatic adenocarcinoma of the pancreas (AVENGER500). Journal Of Clinical Oncology 2022, 40: 4023-4023. DOI: 10.1200/jco.2022.40.16_suppl.4023.Peer-Reviewed Original ResearchProgression-free survivalMetastatic pancreatic cancerOverall response rateMedian overall survivalFirst-line therapyCPI-613Experimental armRandomized phase 3 trialStandard first-line therapyTreatment-emergent adverse eventsDoses of irinotecanTreatment-naïve patientsPhase 3 trialDuration of responseLimited treatment optionsPatient reported outcomesTest armIntolerable toxicityPrimary endpointSecondary endpointsAdverse eventsOverall survivalMetastatic adenocarcinomaTreatment optionsControl arm
2019
Antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients (pts) with advanced HER2+ (IHC3+) gastric carcinoma (GC).
Catenacci D, Lim K, Uronis H, Kang Y, Ng M, Gold P, Enzinger P, Lee K, Lacy J, Park H, Yen J, Odegaard J, Franovic A, Baughman J, Wynter-Horton A, Chen F, Moore P, Wu T, Davidson-Moncada J, Bang Y. Antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients (pts) with advanced HER2+ (IHC3+) gastric carcinoma (GC). Journal Of Clinical Oncology 2019, 37: 65-65. DOI: 10.1200/jco.2019.37.4_suppl.65.Peer-Reviewed Original ResearchDisease control rateObjective response ratePD-L1 expressionGastric carcinomaHER2 expressionHigh PD-L1 expressionStandard first-line therapyTumor PD-L1 expressionChemo-free regimenDrug-related SAEsFirst-line therapyProgression-free survivalAnti-HER2 agentsAutoimmune hepatitisExploratory endpointsMedian overallDiabetic ketoacidosisAcceptable tolerabilityAdvanced HER2Adverse eventsPD-L1Control rateIHC 3Grade 3Archival tumors