Negative EMA opinion for the ipilimumab/nivolumab combination

Yesterday it was announced that the combination of ipilimumab and nivolumab has not been recommended by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for the first-line treatment of metastatic renal cell carcinoma (RCC). Bristol-Myers Squibb (BMS), the manufacturers of both ipilimumab and nivolumab, will be pursuing a re-examination of the ipilimumab-nivolumab data that was submitted to the CHMP.

Although the results from CheckMate-214, which compares the ipilimumab and nivolumab combination with sunitinib in previously untreated RCC patients, resulted in improved survival in those patients given the combination, there was no evidence showing if ipilimumab contributed to these results and if so, how much. It is known that nivolumab alone benefits previously treated patients with RCC. However, there is no way of knowing if the addition of ipilimumab to nivolumab produced additional benefit.

The combination treatment with ipilimumab resulted in more side effects than seen with nivolumab alone. Combination treatments can provide benefits over and above the use of single medicines; however, it is vital that the contribution of each drug in the combination is proven to avoid giving unnecessary or ineffective treatments, particularly if the combination exposes patients to additional, potentially severe side effects.

Therefore, the CHMP’s opinion is that the combination of ipilimumab plus nivolumab could not be recommended because of the lack of knowledge of the ipilimumab contribution to the survival benefit seen with the combination versus sunitinib in the first-line setting.

This is very disappointing news for European kidney cancer patients, particularly when the combination treatment has been proven to be superior to sunitinib in terms of response rates for intermediate- and poor-risk patients and is already available for use in the USA.

KCSN is a key stakeholder in the NICE appraisal for the ipilimumab-nivolumab combination, which has been suspended until BMS have explored their options going forward.

We will, of course, keep you updated with any further information we receive about this drug combination.

Read the press release from the EMA here

Read the press release in Reuters here

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