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dc.contributor.authorVan Cutsem, Ericen
dc.contributor.authorEng, Cathyen
dc.contributor.authorNowara, Elzbietaen
dc.contributor.authorSwieboda-Sadlej, Annaen
dc.contributor.authorTebbutt, Niall Cen
dc.contributor.authorMitchell, Edithen
dc.contributor.authorDavidenko, Irinaen
dc.contributor.authorStephenson, Joeen
dc.contributor.authorElez, Elenaen
dc.contributor.authorPrenen, Hansen
dc.contributor.authorDeng, Hongjieen
dc.contributor.authorTang, Ruien
dc.contributor.authorMcCaffery, Ianen
dc.contributor.authorOliner, Kelly Sen
dc.contributor.authorChen, Lisaen
dc.contributor.authorGansert, Jenniferen
dc.contributor.authorLoh, Elwynen
dc.contributor.authorSmethurst, Dominicen
dc.contributor.authorTabernero, Josepen
dc.identifier.citationClinical Cancer Research : An Official Journal of the American Association For Cancer Research 2014; 20(16): 4240-50en
dc.description.abstractPanitumumab, a fully human anti-epidermal growth factor receptor monoclonal antibody (mAb), has demonstrated efficacy in patients with wild-type KRAS metastatic colorectal cancer (mCRC). Rilotumumab and ganitumab are investigational, fully human mAbs against hepatocyte growth factor (HGF)/scatter factor and IGF1R, respectively. Here we evaluate combining rilotumumab or ganitumab with panitumumab in previously treated patients with wild-type KRAS mCRC.Part 1 was a phase Ib dose-finding study of panitumumab plus rilotumumab. The primary endpoint was the incidence of dose-limiting toxicities (DLT). Part 2 was a randomized phase II trial of panitumumab in combination with rilotumumab, ganitumab, or placebo. The primary endpoint was objective response rate (ORR); safety, progression-free survival (PFS), and overall survival (OS) were secondary endpoints. Archival tissue specimens were collected for exploratory correlative work.In part 1, no DLTs were reported. A recommended phase II dose of 10 mg/kg rilotumumab was selected. In part 2, for the panitumumab plus rilotumumab (n = 48), panitumumab plus ganitumab (n = 46), and panitumumab plus placebo arms (n = 48), the ORRs were 31%, 22%, and 21%, respectively. The median PFS was 5.2, 5.3, and 3.7 months and median OS 13.8, 10.6, and 11.6 months, respectively. Adverse events were tolerable. Exploratory biomarker analyses, including MET and IGF-related protein expression, failed to indicate conclusive predictive evidence on efficacy endpoints.Panitumumab plus rilotumumab met the prespecified criterion for improvement in ORR whereas ganitumab did not. This is the first study to suggest a benefit for combining an HGF inhibitor (rilotumumab) with panitumumab in previously treated patients with wild-type KRAS mCRC.en
dc.titleRandomized phase Ib/II trial of rilotumumab or ganitumab with panitumumab versus panitumumab alone in patients with wild-type KRAS metastatic colorectal cancer.en
dc.typeJournal Articleen
dc.identifier.journaltitleClinical cancer research : an official journal of the American Association for Cancer Researchen
dc.identifier.affiliationAustin Health, Heidelberg, VIC, Australiaen
dc.identifier.affiliationUniversity Hospitals Gasthuisberg and KU Leuven, Leuven, Belgiumen
dc.identifier.affiliationVall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spainen
dc.identifier.affiliationUniversity of Texas M.D. Anderson Cancer Center, Houston, Texas;en
dc.identifier.affiliationInstytut im. M. Sklodowskiej-Curie, Gliwice;en
dc.identifier.affiliationWarszawski Uniwersytet Medyczny, Warszawa, Poland;en
dc.identifier.affiliationThomas Jefferson University, Philadelphia, Pennsylvania;en
dc.identifier.affiliationKrasnodar City Oncology Center, Krasnodar, Russia;en
dc.identifier.affiliationCancer Centers of the Carolinas, Greenville, South Carolina;en
dc.identifier.affiliationAmgen Inc., ThoUSAnd Oaks;en
dc.identifier.affiliationAmgen Inc., South San Francisco, California;en
dc.identifier.affiliationAmgen Ltd., London, United Kingdom.en
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