Roche presents new data for advanced bladder cancer immunotherapy
pharmafile | January 8, 2016 | News story | Medical Communications, Research and Development | Roche, atezolizumab, bladder cancer
Roche has announced updated results from a pivotal Phase II study, showing its investigational cancer immunotherapy atezolizumab extended median progression free survival in people with bladder cancer.
The study also showed that 84% of people who responded to atezolizumab (also known as MPDL3280A) continued to respond regardless of their PD-L1 status, when the results were assessed with longer median follow-up of 11.7 months. Median duration of response has not yet been reached.
Median overall survival in this heavily pre-treated population was 11.4 months in people with locally advanced or metastatic urothelial carcinoma and higher levels of PD-L1 expression, and 7.9 months in the overall study population of IMvigor 210.
Atezolizumab targets the PD-L1 protein, and is designed to initiate a T-cell immune response, restoring their ability to effectively detect and attack cancer tumour cells. Atezolizumab was well tolerated in the trial, and adverse events were consistent with those observed in previous updates.
“It is encouraging to see that the majority of people with advanced bladder cancer who responded to atezolizumab maintained their response with longer follow up,” says Sandra Horning, chief medical officer and head of global product development at Roche. “We are looking forward to sharing these results with the US FDA and other health authorities in the hope that we may bring atezolizumab to treating physicians and their patients as soon as possible.”
Roche said it would quickly submit the data to global health authorities, as the treatment has Breakthrough Therapy designation in the US.
Metastatic urothelial cancer is a disease currently with limited treatment options and associated with a poor prognosis. No major advancements in survival outcomes have been achieved for nearly 30 years.
Urothelial cancer is the ninth most common cancer worldwide, with 430,000 new cases diagnosed in 2012, and it results in approximately 145,000 deaths globally each year. Men are three times more likely to suffer from urothelial cancer compared with women, and it is also three times more common in developed countries than in less developed countries.
Joel Levy
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