FDA approves new bladder cancer treatment following BCI-led clinical trial

Zoe Leech Posted in General News 20 May 2016

Tecentriq is the first PD-L1 inhibitor approved by the FDA

Following a groundbreaking trial of a new bladder cancer treatment published in Nature in late 2014, the US Food and Drug Administration (FDA) approved the immunotherapy for patients with advanced disease this week, on May 18th. The clinical trial was also covered in the media by the BBC, Telegraph, Mail, Mirror and others.

The early results of the multicentre trial led by BCI's Professor Tom Powles were so promising that the antibody drug was given breakthrough therapy designation status, priority review status and accelerated approval by the FDA. This is the first treatment advance for this cancer type in 3 decades and should help many patients for whom existing treatments have not proved effective.

The treatment is an antibody called atezolizumab (or Tecentriq™, Genentech, Inc.) that blocks a protein called PD-L1 thought to help cancer cells evade immune detection; programmed death ligand 1 is found on the surface of some bladder cancer cells. The antibody binds PD-L1 and stops it "hiding" the cancer cells from the immune system.

Prof. Powles said:

Atezolizumab is the first new drug to be approved in advanced bladder cancer in the USA for 30 years. It is an immune therapy that works by inhibiting a protein - PD-L1. Investigators at Barts Cancer Institute led the initial clinical trials with this drug. It is hoped that it will be approved in Europe in the near future.

As part of the official announcement, the FDA's Office of Hematology and Oncology Products Director, Dr Richard Pazdur, said:

Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells.

While patients who received Tecentriq™ responded across the trial study, the greater effect in those classified “positive” for PD-L1 expression suggested that the level of PD-L1 expression in tumor-infiltrating immune cells may help identify patients who are more likely to respond to treatment with Tecentriq. Therefore, the FDA simultaneously approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumour-infiltrating immune cells to help physicians determine which patients could benefit most from the new treatment.

Bladder cancer is the 7th most common cancer in the UK and around 10% of diagnoses are advanced (meaning it has already spread - metastasised - to another part of the body). This makes it very difficult to treat, with chemotherapy the only option. On average patients live 12-18 months following diagnosis, with many choosing to forego chemotherapy due to its toxicity and limited survival benefit.

This newly approved immunotherapy presents a new treatment option for these people with advanced disease that could significantly extend survival.

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