The European Commission has approved Opdivo (nivolumab) monotherapy for an additional indication in advanced renal cell carcinoma (RCC) after prior therapy in adults, announced Bristol-Myers Squibb Company.

To demonstrate an overall survival (OS) benefit versus a standard of care in this patient population, Opdivo is the first and only PD-1 immune checkpoint inhibitor approved in Europe. The approval means that in previously treated advanced RCC in all 28 Member States of the European Union, Opdivo can now be marketed extensively.

“Today’s approval is reflective of our commitment to bring Opdivoand the potential for long-term survival to broad patient populations, including previously treated advanced renal cell carcinoma. Opdivo is the only PD-1 inhibitor approved in Europe to demonstrate a significant survival advantage in this patient population,” said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb.

The results of the Phase 3 study CheckMate -025 which were published in The New England Journal of Medicine formed the basis of the approval. Compared to everolimus, Opdivo was evaluated in patients with advanced clear-cell RCC who received prior anti-angiogenic therapy in CheckMate -025. A median OS of 25 months versus 19.6 months for everolimus was achieved for patients treated with Opdivo. This represented a greater than five month improvement over a current standard of care.

“For the first time, previously treated advanced renal cell carcinoma patients in Europe will now have access to an Immuno-Oncology agent that has demonstrated a significant overall survival benefit along with a favorable safety profile compared to everolimus. In addition to the clinical efficacy results, patients treated with Opdivo experienced an improvement in their health-related quality of life and had significantly lower symptom burden throughout treatment compared to patients receiving everolimus,” said Dr. Bernard Escudier, Chair of the Genitourinary Oncology Committee, Institut Gustave Roussy in Villejuif, France.

Important progress toward establishing a new standard of care in Europe is represented by the combination of these data which support the use of Opdivo in clinical practice, Dr. Escudier added.

With overall survival (OS) as the primary endpoint, CheckMate -025 is an open-label, randomized Phase 3 study, which evaluated Opdivo versus everolimus in patients with advanced clear-cell renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. As a secondary end point objective response rate (ORR) was evaluated. Compared to everolimus (10 mg administered orally daily), patients were randomized to receive Opdivo (3 mg/kg administered intravenously every two weeks) in the study.

Patients treated with Opdivo achieved a more than five month improvement in OS, with median OS of 25 months for Opdivo and 19.6 months for everolimus, showed results from CheckMate -025. An improvement over time in disease related symptoms and non-disease specific quality of life compared to patients receiving everolimus was also experienced by patients in addition to the OS benefit observed with Opdivo.

(Adapted from streetinsider.com)