Eli Lilly's Cyramza took a big step toward joining immuno-oncology agents as go-to therapies for bladder cancer, after improving progression-free survival in a phase III trial.
The US-based pharma group said its RANGE study of Cyramza (ramucirumab) in patients with locally advanced, unresectable or metastatic urothelial carcinoma (mUC) - the most common form of bladder cancer - could support possible filings next year.
The trial is the first to show improved PFS compared to chemotherapy in mUC patients who have previously been treated with a first-line platinum-based regimen said Lilly, but it thinks it will have to demonstrate a benefit on overall survival to be able to file for approval of Cyramza in this indication, setting back a possible approval into 2019.
If all goes according to plan however, Cyramza - a VEGF receptor 2 inhibitor that works by blocking blood vessel growth in tumours - could join the increasing list of immuno-oncology drugs that are starting to transform the treatment of bladder cancer after decades of stagnation.
To date Merck & Co's Keytruda (pembrolizumab) and Roche's Tecentriq (atezolizumab) have been approved for first- and second-line treatment of mUC, while three other PD-1/PD-L1 inhibitors - Bristol-Myers Squibb's Opdivo (nivolumab), Merck KGaA/Pfizer's Bavencio (avelumab), and AstraZeneca's Imfinzi (durvalumab) - are licensed as second-line therapies for this type of cancer. Roche had a setback after a confirmatory trial for Tecentriq in this indication failed, but overall the new agents have achieved compelling results in mUC.
Adding to its potential RANGE included some patients who were previously treated with PD-1/PD-L1 inhibitors, suggesting it could become a key part of the emerging medicine armamentarium in bladder cancer adding another line of attack along with immuno-oncology and chemotherapy agents.
"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," said Lilly in a statement on the data.
The new indication would be a big boost for Cyramza, which has been a big earner for Lilly since its launch in 2014 but saw sales in the US for indications such as lung cancer fall back as a result of a switch to immuno-oncology drugs last year and pricing pressures.
It's still posting good growth overall however, bringing in $614m last year and up 60% thanks to big gains in Japan in the stomach cancer category.