Eli Lilly’s (LLY - Free Report) oncology treatment, Cyramza, failed to meet the primary endpoint in a global, randomized, double-blind study (REACH) conducted in hepatocellular (liver) cancer patients.
Cyramza plus best supportive care was compared to placebo plus best supportive care for the second-line treatment of patients who have been treated with Nexavar (sorafenib) in the first-line setting. Although overall survival favored the Cyramza arm, results were not statistically significant.
Meanwhile, meaningful improvements in key secondary endpoints like progression-free survival, overall response rate and time to progression were observed with single-agent Cyramza. Safety data was in-line with that seen in previous studies conducted with single-agent Cyramza.
Eli Lilly intends to meet with regulatory authorities to discuss the overall efficacy especially that seen in specific subpopulations.
The results are disappointing as Cyramza’s label expansion would increase the commercial potential of the treatment significantly. Eli Lilly has faced a setback with Cyramza earlier too when it failed to achieve the primary endpoint in a phase III breast cancer study.
Eli Lilly has orphan drug status for Cyramza for liver cancer in the U.S. as well as the EU. Liver cancer, once it advances, is very difficult to treat – surgery is no longer an option and with no approved treatments in the second-line setting, patients depend on supportive care.
Cyramza is currently approved as a single agent for the treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma in patients whose disease has progressed after treatment with fluoropyrimidine- or platinum-containing chemotherapy. Eli Lilly is evaluating Cyramza for second-line non-small cell lung cancer (regulatory filing scheduled this year) as well as colorectal cancer (phase III data due later this year).
Eli Lilly, which is facing generic competition for drugs like the Zyprexa, Cymbalta and Evista, needs to bring new products to market to help make up for the loss of revenues to genericization.
Eli Lilly is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Allergan (AGN - Free Report) , Gilead Sciences, Inc. (GILD - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) . All three are Zacks Rank #1 (Strong Buy) stocks.