Eli Lilly and Company reported mixed results for its cancer drug, Cyramza (ramucirumab) as a second-line treatment for people with hepatocellular carcinoma (HCC), also known as liver cancer. In a Phase III trial (REACH), while the trial’s primary endpoint of overall survival favored the Cyramza arm, it was not statistically significant. Lilly reports, however, encouraging single-agent Cyramza activity was observed, with meaningful improvements in key secondary endpoints as well as within certain patient subgroups.

Ramucirumab has been granted Orphan Drug Designation for treatment of hepatocellular carcinoma in the US and EU. “Globally, a high unmet need exists in second-line hepatocellular carcinoma, and currently there are no therapies approved in the U.S., EU or Japan to treat patients in this setting,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology, in a company release. “We are encouraged by the efficacy seen overall in the REACH study, especially in specific subpopulations, and we hope to confirm those results with the new CyramzaA Phase III trial.”

In the US, Cyramza is approved for use as a single agent or in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel (a type of chemotherapy) as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with Folfiri (a type of chemotherapy) as a treatment for people with metastatic colorectal cancer whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Cyramza is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. CYRAMZA inhibited angiogenesis in an in vivo animal model Lilly has several additional studies underway or planned to investigate Cyramza as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.

Source: Eli Lilly and Company