Lilly's Cyramza scores in bladder cancer
- Eli Lilly & Co. revealed Wednesday morning that its potential blockbuster Cyramza (ramucirumab) met its primary endpoint of improving progression free survival (PFS) in a study of patients with advanced bladder cancer.
- According to Lilly, the RANGE study is the first Phase 3 trial to show superior PFS over chemotherapy in a post-platinum setting in urothelial cancer.
- While the primary endpoint of the study has been met, Lilly anticipates needing overall survival (OS) data for a regulatory submission and expects to have that data in hand by mid-2018.
While Lilly doesn’t expect to announce the particulars of the RANGE study until later this year at an upcoming medical meeting, the positive results are a boon for the Indianapolis pharma.
Bladder cancer has been a particularly hot area of late as many of the closely watched checkpoint inhibitors have recently gained approval in the indication, including Pfizer’s approval for Bavencio (avelumab) in May.
Roche, however, hit a setback earlier this month, announcing its checkpoint inhibitor Tecentriq (atezolizumab) failed to meet the primary endpoint in a Phase 3 trial for locally advanced or metastatic urothelial cancer.
The drug was approved for the indication based on Phase 2 data under the Food and Drug Administration’s accelerated approval process.
Most of the recent approvals in bladder cancer have been based on the accelerated process and need confirmatory trials to prove their efficacy in the indication. The recent Roche failure could mean that the checkpoint inhibitors aren’t as effective in the indication as previously thought.
Lilly’s Cyramza now has a shot at carving out a space in the indication as the RANGE data puts Lilly in a strong position. But the market won't wait for Lilly — a mid-2018 readout of OS results could mean an approval wouldn't come through until 2019.
"While there have been several recent advancements to treat this type of cancer, most patients progress despite treatment with existing therapies, including immune checkpoint inhibitors," noted the Wednesday statement from Lilly.
- Eli Lilly & Co. Press release
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