CHMP adopts positive opinion of Opdivo in NSCLC and RCC
Posted: 26 February 2016 | | No comments yet
Both indications are supported by Phase 3 studies in which Opdivo demonstrated a survival benefit versus a standard of care…
The the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for two new indications – adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and adults with advanced renal cell carcinoma (RCC) after prior therapy.
Both indications are supported by Phase 3 studies in which Opdivo demonstrated a survival benefit versus a standard of care. The CHMP positive opinions will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Opdivo is already approved by the EC for advanced melanoma and previously treated advanced squamous NSCLC.
Commenting on the recommendation, Michael Giordano, M.D., senior vice president, head of Development, Oncology, Bristol-Myers Squibb, said: “Today’s two positive CHMP opinions are important achievements and mean we are closer to reaching this goal for those with advanced non-squamous non-small cell lung cancer and renal cell carcinoma. We look forward to the European Commission’s decision and the opportunity to bring an additional treatment option to these patients as quickly as possible.”
Opdivo demonstrated superior overall survival in studies
In lung cancer, the CHMP adopted the positive opinion based on a review of the global Phase 3 study, CheckMate -057, which evaluated the survival of patients with non-squamous NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. In the trial, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death, based on a prespecified interim analysis. The median OS was 12.2 months in the Opdivo arm and 9.4 months in the docetaxel arm. Fifty-one percent of patients were alive at one year in the Opdivo arm vs. 39% in the docetaxel arm. The safety profile of Opdivo in CheckMate -057 was consistent with prior studies.
In renal cell carcinoma, the CHMP adopted the positive opinion based on a review of the Phase 3 study, CheckMate -025, which evaluated Opdivo versus everolimus in patients with advanced clear-cell RCC after prior therapy, with OS as the primary endpoint. Patients treated with Opdivo in this study achieved a more than five month improvement in OS with median OS of 25 months for Opdivo and 19.6 months for everolimus, with OS benefit seen regardless of PD-L1 expression. Opdivo is the first and only anti-PD-1 therapy to demonstrate a significant survival benefit in this population through a randomized Phase 3 study. In addition, patients treated with Opdivo also experienced a significant improvement in their health-related quality of life and had significantly lower symptom burden compared to patients receiving everolimus. The safety profile of Opdivo in CheckMate -025 was consistent with prior studies.