Abstract 1015TiP
Background
Ramucirumab (an IgG1 vascular endothelial growth factor receptor-2 antagonist) is the first and only treatment approved in a biomarker-selected population with advanced hepatocellular carcinoma (HCC). Ramucirumab was approved in HCC based on data from patients with alpha-fetoprotein (AFP) levels ≥400 ng/mL in the phase III REACH (NCT01140347) and REACH-2 (NCT02435433) studies. Similar to other contemporary studies, the REACH-2 intention-to-treat (ITT) population did not include patients who received first-line systemic therapy other than sorafenib, since sorafenib was the only treatment with demonstrated overall survival (OS) benefit when the studies were initiated. This global, open-label expansion (OLE) cohort of REACH-2 was initiated to study ramucirumab in patients with advanced HCC and baseline AFP ≥400 ng/mL following non-sorafenib based systemic therapy.
Trial design
This single-arm, open-label, global OLE investigates ramucirumab in patients with advanced HCC who received 1-2 lines of prior systemic therapy for HCC other than sorafenib or chemotherapy (i.e. a tyrosine kinase inhibitor as monotherapy or in combination with an immune checkpoint inhibitor). Eligible patients will have Barcelona Clinic Liver Cancer stage C or B disease (refractory or not amenable to locoregional therapy), Child-Pugh class A liver disease, an Eastern Cooperative Oncology Group performance status of 0/1, and baseline AFP ≥400 ng/mL. Patients who received a prior liver transplant are eligible. Approximately 44 patients will be enrolled to receive ramucirumab 8 mg/kg intravenously once every 14 days. The primary objective is safety. Secondary objectives are OS, progression-free survival, time to radiographic progression, objective response rate, pharmacokinetics, immunogenicity, and patient-reported outcomes. All analyses of the OLE will be independent of the main randomized, double blind, placebo-controlled ITT cohort of REACH-2.
Clinical trial identification
NCT02435433.
Editorial acknowledgement
Medical writing support was provided by Andrew Sakko, PhD, CMPP, and editorial support was provided by Dana Schamberger, MA, of Syneos Health and funded by Eli Lilly and Company in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
Legal entity responsible for the study
Eli Lilly and Company.
Funding
Eli Lilly and Company.
Disclosure
R.S. Finn: Advisory/Consultancy: Eli Lilly and Company; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: Bristol Myers-Squibb; Advisory/Consultancy: Eisai; Advisory/Consultancy: CStone; Advisory/Consultancy: Merck; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche/Genetech. P.R. Galle: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Bayer; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Eli Lilly and Company; Honoraria (self), Honoraria (institution): Sirtex Medical; Honoraria (self), Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Honoraria (institution): Ipsen; Honoraria (self), Honoraria (institution): Eisai. C. Wang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly and Company. K.D. Ogburn: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly and Company. R. Widau: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly and Company. A.X. Zhu: Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Eli Lilly and Company; Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Merck; Advisory/Consultancy: Eisai; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Roche/Genetech. All other authors have declared no conflicts of interest.