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Positive first-line phase 3 results for Tecentriq

Hopes to extend use in bladder cancer


Roche has revealed that its blockbuster drug Tecentriq (atezolizumab) has met its co-primary endpoint in an ongoing study in bladder cancer, with hopes that the drug can be expanded for use in a wider patient population.

The results came from Roche’s IMvigor130 study, currently in phase 3, which is assessing the use of Tecentriq in combination with platinum-based chemotherapy in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC). Urothelial carcinoma is the most common type of bladder cancer, and accounts for around 90% of cases, with 30% of those considered to be advanced.

Against chemotherapy alone, the Tecentriq-chemotherapy combination showed statistically significant results in the investigator-assessed progression-free survival (PFS) endpoint, as there was a reduction in the risk of disease worsening or death in the targeted patient population.

Roche also reported that the Tecentriq-chemotherapy combination demonstrated encouraging overall survival results at this interim analysis. However, they did admit that the data is not yet mature, and promised a follow-up for the next planned analysis.

Roche is set to present the results at an upcoming medical meeting, in addition to being shared with global health authorities including the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA).

Sandra H

Sandra Horning, chief medical officer, Roche

“These results support our broad clinical development programme for Tecentriq in bladder cancer, as well as our approach of combining immunotherapy with chemotherapy or other medicines to improve patient outcomes, and we look forward to discussing them with health authorities,” said Sandra Horning, chief medical officer at Roche.

Tecentriq was the third drug to hit the growing PD-1/PD-L1 inhibitor category, with Bristol-Myers Squibb’s Opdivio and Merck & Co’s Keytruda the first to establish a foothold in the market.

Roche's PD-L1 inhibitor was the first to get approval for an immuno-oncology drug in bladder cancer when it emerged onto the market in 2016, and is currently only approved for use in people with mUC whose disease has progressed during or after platinum-based chemotherapy. With the Imvigor130 study, Roche is hoping to extend Tecentriq's use to those who have not had prior treatment. If Tecentriq can meet the secondary endpoints of the study as a first-line treatment, the drug could see Roche establish dominance in the bladder cancer market.

Since its first approval, Tecentriq has continued to help drive growth for Roche, with the Swiss pharma company reporting a 141% increase in the first half of 2019 compared to the same period last year, as the drug grew to deliver revenues of $787m.

According to Roche’s pharma division chief Bill Anderson, 20% of Tecentriq’s revenue stream came from its indication in bladder cancer in the second quarter of 2019. With these positive results from the use of Tecentriq in a wider population of people with bladder cancer, and phase 3 results in liver cancer also expected soon, Roche seems set to solidify Tecentriq’s place as the third biggest checkpoint inhibitor in the market.

Article by
Lucy Parsons

5th August 2019

From: Research



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