Immunotherapy Combination Denied Regulatory Approval in Europe

The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency, has handed down a negative opinion on the approval of combination ipilimumab and nivolumab for the frontline treatment of advanced renal cell carcinoma. The main reason for this decision is the lack of a nivolumab monotherapy arm in the study. This decision currently leaves a treatment with up to 16 percent complete response rate in intermediate and poor risk disease groups unavailable to European patients. This combination therapy leaves much to be desired, including a high requirement for steroid use to manage side effects, and significant cost. However, the clinical efficacy is indisputable, and in patients with intermediate and poor risk features, clearly superior to the comparator, sunitinib, in terms of overall survival with an impressive hazard ratio of 0.63 and quality of life improvement across the entire treatment period.

We anticipate an appeal to this decision, with the hope that this combination therapy will be made available to European patients with advanced RCC possessing intermediate and poor risk features. We would welcome a conditional approval, coupled with prospective testing of the ipilimumab-nivolumab combination against nivolumab monotherapy in the frontline setting. This would allow patients access to this regimen in the meantime, and provide valuable additional information.

As the global coalition of kidney cancer patient organisations, the IKCC remains committed to supporting patient organisations throughout Europe with evidence-based treatment information to inform best quality care according to international and European guidelines for renal cell carcinoma.

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