Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 3

REACH-2; NCT02435433

Hepatocellular Carcinoma

VEGF Receptor-2 Antagonist


A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-line Therapy With Sorafenib*

NCT02435433
Key Inclusion Criteria
  • Hepatocellular carcinoma (HCC)
  • Barcelona Clinic Liver Cancer stage C or B that is refractory or not amenable to locoregional therapy
  • At least one target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Child-Pugh class A
  • Baseline serum AFP ≥400 ng/mL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Received prior sorafenib as the only systemic therapeutic intervention and experienced radiographically confirmed disease progression during or after discontinuation or discontinued sorafenib because of intolerance (main and maximum extended enrollment [ME2] cohorts only)
  • Received ≤2 prior systemic therapy regimens, excluding prior sorafenib or chemotherapy for the treatment of HCC (open-label expansion [OLE] cohort only)
  • Adequate hematologic and biochemical parameters
Key Exclusion Criteria
  • Uncontrolled hypertension
  • Esophageal or gastric varices requiring treatment
  • Ongoing or recent hepatorenal syndrome
  • Liver transplant (main and ME2 cohorts only; participants with prior liver transplant may be eligible for OLE cohort)
  • Major surgery within 28 days
  • Arterial thrombotic event within 6 months
  • Received prior therapeutic anticoagulation or chronic antiplatelet agents, including nonsteroidal anti-inflammatory drugs
  • History of or current hepatic encephalopathy (any grade) or ascites grade ≥2
*
This clinical trial is being conducted globally. ME2 cohort is being conducted in China only. REACH-2 eligibility criteria, including baseline serum AFP criterion, are based on the efficacy and safety results of REACH.
Ramucirumab or placebo equivalent is administered 8 mg/kg intravenously on day 1 of a 14-day cycle.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.