The company have advised NICE that CheckMate -143, a randomised phase 3 clinical trial evaluating the efficacy and safety of nivolumab in patients with first recurrence of glioblastoma multiforme, did not meet its primary endpoint of improved overall survival compared to bevacizumab monotherapy and therefore they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes. In addition, the company has ongoing clinical trials in newly-diagnosed glioblastoma multiforme (CheckMate -498 and CheckMate -548). These trials are moving forward as planned.
 
Status Suspended
Process STA pre-2018
ID number 998

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
10 May 2017 Suspended. The company have advised NICE that CheckMate -143, a randomised phase 3 clinical trial evaluating the efficacy and safety of nivolumab in patients with first recurrence of glioblastoma multiforme, did not meet its primary endpoint of improved overall survival compared to bevacizumab monotherapy and therefore they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes. In addition, the company has ongoing clinical trials in newly-diagnosed glioblastoma multiforme (CheckMate -498 and CheckMate -548). These trials are moving forward as planned.
22 July 2016 Referral

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