Eli Lilly’s had mixed results in its quest to expand cancer blockbuster hopeful Cyramza. But the data from its latest attempt, this time in bladder cancer, look good.
Wednesday, the Indianapolis drugmaker announced that a phase 3 study of the med in urothelial carcinoma patients had met its primary endpoint, significantly beating out placebo on the progression-free survival front. And that leaves the door open for an FDA approval down the line.
Lilly wouldn’t mind the extra indication; right now, it boasts nods in metastatic non-small cell lung cancer, advanced stomach cancer and metastatic colorectal cancer that helped rake in $614.1 million in sales last year. And trials of the med in liver cancer and breast cancer have come up short.
Bladder cancer, of course, won’t necessarily be an easy arena to enter, considering the presence of five checkpoint inhibitors—four of which won their approvals in the last few months—in the space. Roche’s Tecentriq picked up the first nod last May, and since then, Bristol-Myers Squibb’s Opdivo, AstraZeneca’s Imfinzi, Pfizer and Merck KGaA’s Bavencio, and Merck’s Keytruda have followed with green lights of their own.
By the time Cyramza, a VEGF med, gets there, though, there’s a chance the field may not be as crowded. Tecentriq’s fate, for one, is hanging in the balance after the med earlier this month failed to prove it could actually prolong patients' lives. That flop put its approval in jeopardy, and Bristol, AZ and the Pfizer/Merck KGaA team—all of whom are still waiting for their own overall survival data—on notice.
With that in mind, Lilly “anticipates that overall survival results are likely to be required for global regulatory submissions,” it said, and it expects final data in that department to arrive in the middle of next year.