Data from Pharmawand - Curated by EPG Health - Date added 20 January 2019

Eli Lilly and Company announced that results from the global Phase III REACH-2 study of Cyramza (ramucirumab) as a single agent in the second-line treatment of people with AFP-High (alpha-fetoprotein greater than 400 ng/mL) hepatocellular carcinoma (HCC) were published online in The Lancet Oncology. Data from REACH-2 are also being presented at the 2019 Gastrointestinal Cancers Symposium in San Francisco. HCC is also known as liver cancer, which is a leading cause of cancer-related death worldwide. In the U.S., liver cancer is one of the few major cancers with incidence rates that continue to rise every year and is the fastest rising cause of cancer death.

REACH-2 showed a statistically significant improvement in the primary endpoint of overall survival (OS) as well as in the secondary endpoint of progression-free survival (PFS). The safety profile observed in the REACH-2 study was consistent with what has been previously observed for single-agent Cyramza in patients with HCC. Additionally, in a pooled analysis comprised of all AFP-High HCC patients across both the REACH-2 and REACH studies, Cyramza treatment also resulted in an improvement in median OS.

REACH-2, the first positive Phase III HCC trial in a biomarker-selected patient population, evaluated the benefit of Cyramza treatment in AFP-High HCC patients who were intolerant to, or had disease progression while on or following treatment with, sorafenib. Approximately half of all advanced HCC patients are AFP-High, and these patients are among those with the poorest prognosis relative to the general HCC patient population. On the primary endpoint of OS, treatment with Cyramza significantly improved the OS of patients compared to placebo (HR 0.71; 95% CI, 0.53-0.95; P=0.02). The median OS was 8.5 months with Cyramza (95% CI, 7.0-10.6), compared to 7.3 months with placebo (95% CI, 5.4-9.1). On the secondary endpoint of PFS, median PFS was significantly improved with Cyramza (2.8 months [95% CI, 2.8-4.1] vs. 1.6 months for placebo [95% CI, 1.5-2.7]) (HR 0.45; 95% CI, 0.34-0.60; P<0.0001). Objective response rate (ORR) was numerically higher with Cyramza compared to placebo (4.6% vs. 1.1%; P=0.1697). Disease control rate (ORR + stable disease) was higher with Cyramza than with placebo (59.9% vs. 38.9%). In a pooled analysis of AFP-High patients (n=542) from REACH-2 and REACH, which provided a larger data set to assess outcomes in this particular patient population, Cyramza improved OS compared to placebo (HR 0.69; 95% CI, 0.57-0.84; P=0.0002), and an improvement of 3.1 months in median OS was observed (8.1 and 5.0 months with Cyramza and placebo, respectively). The HR for OS across all pre-specified pooled subgroup analyses favored the Cyramza treatment arm. PFS, ORR and disease control rate were consistent with those in REACH and REACH-2, and supported the pooled OS result.

The safety profile observed in the REACH-2 study was consistent with what has been previously observed for single-agent Cyramza in patients with HCC. The Grade greater than three adverse events occurring at a rate of five percent or greater in the Cyramza arm were hypertension and hyponatremia (low sodium). These data were first presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) and 2018 World Congress on Gastrointestinal Cancer.

See- "Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased ?-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial".- Andrew X Zhu, Yoon-Koo Kang, Chia-Jui Yen, Richard S Finn, Peter R Galle, Josep M Llovet, and others. The Lancet Oncology Published: January 18, 2019.DOI:https://doi.org/10.1016/S1470-2045(18)30937-9.

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