The National Institute for Health and Care Excellence (NICE) has reversed its draft decision, and is now recommending that Opdivo (nivolumab) be available to National Health Service (NHS) patients with renal cell carcinoma who progressed despite a previous therapy.
Opdivo is the first checkpoint inhibitor to be recommended for this indication, and it is now available for NHS patients in England and Wales. The NICE decision was delivered in what is called a Final Appraisal Determination.
“This decision is a major turning point, which will bring a new wave of immunotherapy to kidney cancer patients,” John Wagstaff, professor of medical oncology, Swansea University, said in a news release. “Nivolumab has demonstrated its potential to improve survival rates in clinical trials and NICE has now recognised the importance of achieving this for patients in England and Wales. This is an aggressive disease that is on the rise and new treatment options are vital to ensure that survival rates are improved in the coming years.”
Over the last four decades in the U.K., the number of patients being diagnosed with kidney cancer each year has more than doubled. In England, more than one-quarter of newly diagnosed kidney cancers are already at an advanced stage, which leads to very poor survival rates.
In the pivotal randomized, open-label, CheckMate 025 Phase 3 trial (NCT01668784), Opdivo prolonged median overall survival in patients with advanced or metastatic clear-cell renal cell carcinoma who had received prior anti-antiogenic therapy (inhibits the formation of new blood vessels), compared to the standard of care treatment with Afinitor (everolimus). While those on Afinitor lived for an average of 19.6 months, Opdivo therapy resulted in a 25-month median overall survival.
In addition, Opdivo was associated with fewer serious grade 3 and grade 4 treatment-related side effects compared to Afinitor.
These findings were the basis of NICE’s decision to recommend Opdivo as a second-line therapy.
“Today’s landmark decision is hugely welcome news for kidney cancer patients and their families. I am delighted that NICE has reversed its recommendation so that patients now have the best possible chance for increased survival,” said Nick Turkentine, CEO of Kidney Cancer UK. “This is a leap forward for cancer care in England and Wales and hopefully the rest of the UK will provide similar decisions as soon as possible.”
It is estimated that nearly 900 patients with advanced renal cancer in England and Wales will benefit from Opdivo therapy each year. Funding is expected to be provided by the NHS within 30 days of the Oct. 21 announcement and, in the meantime, the Cancer Drugs Fund will assume financial support.
“Nivolumab is a game-changing medicine that has demonstrated survival benefits in a number of cancer types and we are very happy that NICE has made this recommendation for patients with advanced kidney cancer and their families,” said Benjamin Hickey, general manager, UK and Ireland, Bristol-Myers Squibb. “While this is a positive outcome for kidney cancer patients, it adds to the deepening cancer medicine disparity in the UK as those with lung cancer are still left without this innovative treatment option. Our goal is to make nivolumab available to everyone who could benefit from it and we urge NICE and NHS England to collaborate with us to find a swift solution for patients.”
In the U.S., Opdivo is an approved treatment for advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, and classical Hodgkin lymphoma. In England and Wales, Opdivo is also available through the NHS to treat advanced melanoma.