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Cyramza fails to meet primary endpoint in hepatocellular carcinoma
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Results from the phase 3 REACH trial have found that ramucirumab did not meet its primary endpoint of OS when used as a second-line treatment for hepatocellular carcinoma, manufacturer Eli Lilly said in a press release.
The REACH trial was a randomized, double-blind trial of 565 patients with a Child-Pugh score <7. Researchers compared ramucirumab (Cyramza) plus supportive care with placebo plus supportive care as second-line therapy in patients who had undergone first-line treatment with sorafenib (Nexavar, Bayer).
The study’s primary efficacy outcome measure was OS, with secondary efficacy outcome measures defined as PFS, overall response rate, time to progression and safety.
While the ramucirumab arm did achieve better OS compared with placebo, these results were not statistically significant.
The safety data were in accord with findings from prior, single-agent ramucirumab studies. Hypertension and fatigue were the most common (>5% incidence) grade ≥3 adverse events that occurred at a higher rate in the ramucirumab arm vs. placebo.
According to Richard Gaynor, MD,senior vice president of product development and medical affairs for Lilly Oncology, the results, while falling short of the goal, are promising.
“Although the REACH study did not achieve statistical significance for survival, we are encouraged by the efficacy seen overall, especially in specific subpopulations,” Gaynor said in the press release. “We plan to discuss these results with regulatory authorities.”
FDA has granted Orphan Drug Designation to ramucirumab for the treatment of hepatocellular carcinoma in the US and EU.
Currently, ramucirumab is FDA-approved as a single agent in the US for patients with advanced gastric cancer gastroesophageal junction adenocarcinoma whose disease has progressed after chemotherapy treatment.
To date, no phase 3 study has been able to show improved survival in the second-line setting for liver cancer, which is a very challenging tumor type.
Lilly intends to present data from the REACH trial at scientific meeting later in 2014, the company said in the press release.