Dive Brief:
- A combination therapy that includes Eli Lilly & Co.'s cancer drug Cyramza didn't significantly improve overall survival (OS) when used as a first-line treatment in patients with HER2-negative metastatic stomach cancer, and now the big pharma won't seek approval for that indication.
- Lilly noted in a Dec. 8 statement that Cyramza in combination with cisplatin and capecitabine or 5-fluorouracil (5-FU) did hit the primary endpoint of progression-free survival in the placebo-controlled Phase 3 RAINFALL study. The miss on OS, a secondary endpoint, looks to have diluted those positive results, however.
- "While we hoped that the positive PFS outcome would have translated into an OS benefit, these RAINFALL results highlight the challenges associated with improving outcomes for people with advanced gastric cancer," said Levi Garraway, head of global development and medical affairs at Lilly Oncology, in a Dec. 8 statement. "This is underscored by the fact that there have been no major advances over standard chemotherapy in the first-line HER2-negative gastric cancer treatment setting in the last decade."
Dive Insight:
Cyramza (ramucirumab) has become a valuable asset for Lilly since first gaining Food and Drug Administration approval back in 2014, but it has also suffered setbacks. In the clinic, Cyramza failed the Phase 3 REACH trial, which investigated it as a treatment for patients with liver carcinoma, and the late-stage ROSE study, which evaluated it as a treatment for breast cancer.
On the market, Lilly has blamed periods where Cyramza uptake was lagging on competition from checkpoint inhibitors, many of which hold the same indications as Cyramza. Lilly's drug is currently approved alone or in combination with paclitaxel for second-line use in advanced or metastatic gastric or gastroesophageal junction adenocarcinoma; in combination with docetaxel for use in metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy; and in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan hydrochloride) for use in metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
Yet even with those issues, Cyramza’s sales stood at $196 million during the third quarter, up 23% year over year. Helping those numbers is the drug's status as the standard of care for advanced gastric cancer after prior chemotherapy.
The RAINFALL study involved 645 patients across 19 countries in North and South America, Asia and Europe. Lilly said the study results do not have any impact on current ramucirumab approvals. Safety data were similar to those see in previous studies, and Lilly intends to present more findings from the trial at a future medical meeting.