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A Phase 3 study, called REACH, evaluating Eli Lilly's (NYSE:LLY) Cyramza (ramucirumab) as second-line treatment [after Nexavar (sorafenib)] in patients with hepatocellular carcinoma (HCC) failed to achieve its primary endpoint of a statistically significant improvement in overall survival (OS). Median OS in the Cyramza plus best supportive care (BSC) arm was 9.2 months versus 7.6 months in the placebo plus BSC arm (p=0.1391). The results were published in The Lancet Oncology.
- A prespecified subgroup of HCC patients with elevated baseline alpha-fetoprotein (AFP), a liver enzyme, did show a statistically valid improvement in survival after receiving ramucirumab. Median OS was 7.8 months compared to 4.2 months for placebo (p=0.0059).
- The company plans to conduct an new Phase 3 study, called REACH-2, to assess Cyramza in a second-line setting in patients with elevated AFP. Enrollment will begin shortly.
- Cyramza is currently approved for the treatment of certain colorectal, gastric and lung cancers and gastroesophageal junction adenocarcinoma.
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