The National Institute for Health and Care Excellence (NICE) has recommended the use of the new immunotherapy treatment atezolizumab for bladder cancer via the Cancer Drugs Fund.
Atezolizumab will be available for people with bladder cancer who have not been previously treated and are not suitable for cisplatin-based chemotherapy – representing half of all metastatic bladder cancer patients in the UK.1,2 Atezolizumab is the first PD-L1 cancer immunotherapy available on the NHS for people with bladder cancer and the first routinely funded major treatment advance for this type of cancer in 30 years.3
Bladder cancer affects around 10,000 people in the UK and when advanced, is associated with poor outcomes; approximately 15% of patients survive more than five years.4,5 As an immunotherapy, atezolizumab harnesses the body’s smartest medicine – the immune system – to detect and destroy cancer. Atezolizumab blocks PD-L1 – an important ligand found on the surface of cancer cells that camouflage them from detection and destruction by the immune system.6 In IMvigor210, atezolizumab has demonstrated a median overall survival of 15.9 months [10.4,NE, 95%CI].7
Richard Erwin, General Manager, Roche, commented: “We welcome the news that patients will now be able to access atezolizumab via the Cancer Drugs Fund. This demonstrates the importance of working collaboratively and flexibly with NICE and NHS England. Looking ahead, it is important that long-term access is achieved and we will be working with NICE to submit further evidence via our ongoing clinical trial programme, which will hopefully see atezolizumab transition into traditional NHS access routes as soon as possible. This is the third Roche medicine approved in 2017 for NHS use and we’re incredibly proud that patients are able to access the medicines we’ve worked so hard to develop.”
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE said: “I am pleased Roche has worked with us and NHS England to address the uncertainties raised by the committee. To have atezolizumab as an option for people who cannot undergo other treatment for their urothelial cancer is a positive thing.”
In late September 2017, atezolizumab received Marketing Authorisation for previously untreated people with advanced bladder cancer unsuitable for (cisplatin-based) chemotherapy, and is currently being trialled in nine other types of cancer. Atezolizumab side-effects were generally manageable in IMvigor210, with around one in five patients experiencing Grade 3 or 4 AEs, but only 4% stopped treatment because of side-effects.8
References
1 National Institute for Health and Care Excellence (2017) Final Appraisal Determination: Atezolizumab for untreated locally advanced or metastatic urothelial carcinoma where cisplatin is unsuitable. October 2017
2 Lei et al. Current treatment of metastatic bladder cancer and future directions. Expert Rev Anticancer Ther. 2011 Dec;11(12):1851-62.
3 Powles T et al. (2014). MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 515(7528).558–62
4 Cancer Research UK. (2016). Bladder Cancer Statistics. Available at: www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer/incidence. [Last accessed: October 2017]
5 Cancer Research UK.(2015). Bladder Cancer Survival. Available from: http://www.cancerresearchuk.org/about-cancer/bladder-cancer/survival Last accessed: October 2017
6 National Cancer Institute (2016) Definition of atezolizumab. NCI Drug Dictionary. Available at: https://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=702758 [Last accessed: October 2017]
7 Bellmunt et al. IMvigor210: updated analyses of first-line (1L) atezolizumab (atezo) in cisplatin (cis)-ineligible locally advanced/metastatic urothelial carcinoma. Poster 782PD Presented at the European Society for Medical Oncology (ESMO 2016) – October 7-11, 2016, Copenhagen, Denmark.
8 Loriot et al. (2016) Atezolizumab (atezo) in platinum (plat)-treated locally advanced/metastatic urothelial carcinoma (mUC): Updated OS, safety and biomarkers from the Phase II IMvigor 2010 Study. Poster 783P Presented at the European Society for Medical Oncology (ESMO 2016) – October 7-11, 2016, Copenhagen, Denmark.