2019
1375TiP Pembrolizumab (pembro) plus lenvatinib (len) for first-line treatment of patients (pts) with advanced melanoma: Phase III LEAP-003 study
Eggermont A, Carlino M, Hauschild A, Ascierto P, Arance A, Daud A, O’Day S, Taylor M, Smith A, Rodgers A, Moreno B, Diede S, Kluger H. 1375TiP Pembrolizumab (pembro) plus lenvatinib (len) for first-line treatment of patients (pts) with advanced melanoma: Phase III LEAP-003 study. Annals Of Oncology 2019, 30: v561. DOI: 10.1093/annonc/mdz255.063.Peer-Reviewed Original ResearchBlinded independent central reviewPD-1 inhibitorsAdvanced melanomaSanofi GenzymeSubsidiary of MerckArray BioPharmaDohme Corp.Pierre FabreRoche-GenentechEnd pointMerck SharpBaseline tumor samplesNCI CTCAE v4.0Performance status 0/1Antitumor activityPrimary end pointSecondary end pointsFirst-line standardFirst-line treatmentUntreated stage IIIIndependent central reviewMurine tumor modelsPDGF receptor αEligible ptsQd poLenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with advanced melanoma previously exposed to anti–PD-1/PD-L1 agents: Phase 2 LEAP-004 study.
Arance Fernandez A, Ascierto P, Carlino M, Daud A, Eggermont A, Hauschild A, Kluger H, Taylor M, Smith A, Chen K, Krepler C, Diede S, O'Day S. Lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with advanced melanoma previously exposed to anti–PD-1/PD-L1 agents: Phase 2 LEAP-004 study. Journal Of Clinical Oncology 2019, 37: tps9594-tps9594. DOI: 10.1200/jco.2019.37.15_suppl.tps9594.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitor therapyPD-L1 inhibitor therapyPD-1 inhibitorsRECIST v1.1Advanced melanomaLast doseInhibitor therapyAnti-PD-1/PD-L1 agentsKey secondary end pointPrimary efficacy end pointEnd pointActive autoimmune diseaseAdequate organ functionBaseline tumor samplesECOG PS 0/1Exploratory biomarker analysisNCI CTCAE v4.0PD-L1 agentsUnresectable stage IIIAntitumor activityEfficacy end pointSecondary end pointsWeeks of therapyPhase 2 trialKey inclusion criteria
2013
Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic melanoma (mM).
Hamid O, Sosman J, Lawrence D, Sullivan R, Ibrahim N, Kluger H, Boasberg P, Flaherty K, Hwu P, Ballinger M, Mokatrin A, Kowanetz M, Chen D, Hodi F. Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic melanoma (mM). Journal Of Clinical Oncology 2013, 31: 9010-9010. DOI: 10.1200/jco.2013.31.15_suppl.9010.Peer-Reviewed Original ResearchObjective response rateMM ptsPD-L1Tumor shrinkageAntitumor activityImmunotherapy-responsive diseasePD-L1 overexpressionTreatment-related deathsPD-L1 statusPD-L1 antibodiesHuman monoclonal antibodyInitial antitumor activityPt ageRECIST responseRECIST v1.1Median durationPrior surgeryPS 0Radiographic progressionSystemic therapyElevated ASTPD-1Dose escalationHistologic subtypeInitial treatment