Swiss pharmaceutical giant Roche has released “encouraging” results from clinical trials of its bladder cancer immunotherapy atezolizumab. The Phase II IMvigor 210 trial assessed the drug in heavily pre-treated patients with locally advanced or metastatic urothelial carcinoma (mUC). Data from the clinical trials showed that patients with high levels of PD-L1 expression had median overall survival of 11.4 months. For the overall study population, the median overall survival was 7.9 months.
Roche to submit data to regulatory authorities
Encouraged by results, Roche said in a press release that it would submit data soon to the US FDA and other health authorities across the globe. The metastatic urothelial carcinoma (mUC) accounts for almost 90% of all cases of bladder cancer in Western countries. Though chemotherapy could give high initial response rates, the median survival rate remains low at just 15 months after diagnosis.
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Roche noted that only 15% of mUC patients stay alive after five years. There have still been no breakthrough treatments in almost 30 years. The Phase II trials revealed that patients already heavily treated with chemotherapy witnessed longer survival after atezolizumab treatment than would be expected from this population. Some people showed a complete response to the therapy.
84% patients continued to respond
The study showed that 84% patients who responded to atezolizumab continued to respond over 11.7 months of follow up, irrespective of their PD-L1 status. Last year, atezolizumab was granted a breakthrough therapy designation in people whose bladder cancer expressed PD-L1. The therapy works by blocking the PD-L1 mechanism that prevents the detection of tumors by the immune system.
Roche has also invested in a cloud-based cancer software startup called Flatiron Health. Flatiron’s software analyzes cancer treatment results to help healthcare providers find the best ways to attack the tumor cells. Flatiron would work with Roche to speed up trials for the drugmaker’s new cancer treatments. The world’s largest maker of cancer drugs currently has 34 drugs in the pipeline.