Results of Cyramza Phase 3 Study not statistically Significant
Results of the new Phase 3 study, called REACH-2, conducted by Eli Lilly and Co., showed that Cyramza therapy did not significantly improve overall survival in patients with advanced hepatocellular carcinoma (HCC) also known as liver cancer.
The liver cancer trial was conducted to see if Cyramza is effective in fighting one of the deadliest cancers. On Friday, Lilly said that Cyramza didn't help patients live significantly longer than patients who were getting a placebo and best supportive care.
Although the selected HCC patients with elevated baseline alpha-fetoprotein (AFP), a liver enzyme, did show improvement in survival after receiving ramucirumab, it was not statistically significant.
However, Lilly said that the trial had showed that a subgroup of patients who had elevated levels of alpha-fetoprotein (protein produced by tumors) and took Cyramza did live almost four months longer than patients in the placebo group.
Trail's principle Dr. Andrew X. Zhu, of Massachusetts General Hospital Cancer Center, said that Cyramza might still be helpful in treating liver cancer patients.
He said, "Advanced liver cancer carries a poor prognosis with limited treatment options. Further analyses from the REACH study have identified AFP (alpha-fetoprotein) as a potential marker for selecting patients with advanced (liver cancer) who may benefit from (Cyramza) treatment".
Dr. Richard Gaynor, a senior vice president for Lilly Oncology, said that they are encouraged by the efficacy seen overall in the REACH study, especially in specific subpopulations. He added that they hope to confirm those results with the new Cyramza phase III trial.
The results were published in The Lancet Oncology.