Dive Brief:
- Eli Lilly’s cancer drug, Cyramza (ramucirumab) has failed in phase III trials in patients with liver disease who did not respond, or were no longer responsive, to first-line treatment.
- In the study, Cymraza did not show a significant survival advantage in the patients studied, but there were noteworthy (though not significant) improvements in secondary endpoints.
- In April, Cyramza became the first FDA-approved, second-line treatment for patients with advanced gastric cancer.
Dive Insight:
While it is true that Cyramza failed to show a significant survival benefit, perhaps “failure” is not the most appropriate term in this situation. To date, no phase III study drug has demonstrated significantly improved survival in patients with advanced liver cancer, which is very difficult to treat.
Phase III data from Lilly’s REACH study did show efficacy with respect to progression-free survival, overall response rate and time to progression, and through the results were not significant, Lilly plans to continue to develop Cyramza for patients with liver cancer.
Cyramza was recently approved by FDA for the treatment of advanced gastric cancer—a first. It has orphan drug status for the treatment of both gastric and liver cancer and plans to continue talks with FDA about future development of Cyramza for liver cancer.