EC expands use of Opdivo in NSCLC and approves its use in advanced RCC

Posted: 6 April 2016 | | No comments yet

The EC has approved Opdivo (nivolumab) for locally advanced or metastatic NSCLC after prior chemotherapy and in advanced RCC after prior therapy…

The European Commission has approved Bristol-Myers Squibb’s Opdivo (nivolumab) monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. 


Opdivo is the only approved PD-1 inhibitor to demonstrate superior overall survival (OS) in two separate Phase 3 trials in previously treated metastatic NSCLC; one trial in squamous NSCLC (CheckMate -017) and the other in non-squamous NSCLC (CheckMate -057), the basis of this approval.

Commenting on the announcement, Emmanuel Blin, senior vice president, Head of Commercialisation, Policy and Operations, Bristol-Myers Squibb, said: “Today’s approval is indicative of our commitment to bringing our Immuno-Oncology science and the potential for long-term survival to a broader range of lung cancer patients in Europe. Opdivo is the only PD-1 inhibitor approved in Europe to have demonstrated, in two separate Phase 3 trials, a significant survival advantage in this patient population, offering a much-needed new treatment option to patients fighting this disease.”

“Meaningful news” for patients with NSCLC

The approval is based on the results of Phase 3 trial, CheckMate -057, where the therapy was evaluated in patients with metastatic non-squamous NSCLC compared to docetaxel, and included patients regardless of PD-L1 expression. Opdivo demonstrated superior OS compared to docetaxel, with a 27% reduction in the risk of death with a one-year survival rate of 51% for Opdivo versus 39% for docetaxel. Biomarker testing for PD-L1 expression is not required with Opdivo. The Summary of Product Characteristics (SmPC) notes that physicians should consider the delayed onset of Opdivo effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease. In non-squamous NSCLC, a higher number of deaths within the first 3 months was observed with Opdivo compared to docetaxel. Factors associated with early deaths were poorer prognostic factors and/or more aggressive disease combined with low or no tumour PD-L1 expression.

Luis Paz-Ares, M.D., Hospital Universitario Doce de Octubre, Madrid, Spain, commented, “Today’s approval expands the availability of Opdivo as a treatment option for a broader range of lung cancer patients – previously treated metastatic squamous and now non-squamous non-small cell lung cancer – which represents the majority of diagnosed lung cancer cases. As the only approved PD-1 inhibitor proven to have demonstrated a survival benefit versus a standard of care, regardless of PD-L1 expression, healthcare providers can offer treatment with Opdivo to appropriate patients who have received prior chemotherapy without the need to first conduct biomarker testing to determine PD-L1 expression. This approval is meaningful news for patients and their families who are in need of new treatment options.”

EC approves Opdivo in advanced RCC

The European Commission has also approved the therapy in advanced renal cell carcinoma (RCC) after prior therapy in adults. 

This approval is based on the results of the Phase 3 study CheckMate -025. In the study, Opdivo was evaluated in patients with advanced clear-cell RCC who received prior anti-angiogenic therapy compared to everolimus. Patients treated with Opdivo achieved a median OS of 25 months versus 19.6 months for everolimus, representing a greater than five month improvement over a current standard of care. CheckMate -025 also evaluated patients’ quality of life (QoL) and found that patients treated with Opdivo had improved survival and QoL compared to everolimus throughout the duration of treatment.

Dr Bernard Escudier, Chair of the Genitourinary Oncology Committee, Institut Gustave Roussy in Villejuif, France, commented, “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 favourable 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. Combined, these data support the use of Opdivo in clinical practice and represent important progress toward establishing a new standard of care in Europe.”

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