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We have just learnt the news that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), is recommending approval of the ipilimumab plus nivolumab combination for previously untreated patients who have intermediate- or poor-risk advanced renal cell carcinoma (RCC). The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
The recommendation is based on the impressive results from the phase 3 CheckMate-214 clinical trial comparing the combination with standard first-line treatment with sunitinib. CheckMate-214 resulted in a significant increase in overall survival (OS) compared to sunitinib, and a 37% decreased risk of death in intermediate- and poor-risk patients, regardless of whether patients were PD-L1 positive. Median OS in patients has not been reached for patients who were treated with the ipilimumab plus nivolumab combination, compared to 25.9 months for patients treated with sunitinib. Objective response rate was 41.6% for the combination versus 26.5% for sunitinib, and median duration of response has not yet been reached versus 18.2 months for sunitinib, indicating a durable response to the combination treatment.
Overall, the safety of the ipilimumab plus nivolumab combination was similar to that previously reported.
“There remains a high unmet medical need for patients with advanced renal cell carcinoma,” said Arvin Yang, MD, PhD, development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We are encouraged by today’s positive opinion from the CHMP and look forward to potentially bringing the first Immuno-Oncology combination therapy to appropriate RCC patients across the EU.”
Kidney Cancer Support Network represented the patient voice on behalf of kidney cancer patients across Europe during re-examination of the data by the CHMP Scientific Advisory Group.
“Ultimately, this is the right decision and will provide hope and encouragement for this group of poorly served patients who are in need of an effective first-line treatment,” said Rose Woodward, Founder and Patient Advocate, Kidney Cancer Support Network. “An overall complete response rate of 9% is unprecedented in intermediate/poor-risk patients, and we are hopeful to have access to this innovative treatment in the near future.”