Yervoy regulatory update

Bristol-Myers Squibb said it no longer plans to seek accelerated approval of Opdivo nivolumab in combination with Yervoy ipilimumab as a first-line treatment for lung cancer. The company said it based its decision on a review of available data. Last August, BMS reported data from the Phase III CheckMate -026 trial showing that Opdivo monotherapy missed the primary endpoint of improving progression-free survival (PFS) vs. investigator’s choice of chemotherapy in the first-line non-small cell lung cancer (NSCLC) setting. In an October presentation, BMS said first-line NSCLC may require combination therapies to confer benefit over chemotherapy (see BioCentury, Aug. 8, 2016).

BMS has said it expects data next year from the Phase III CheckMate -227 trial, which is evaluating the combination, Opdivo as monotherapy, and Opdivo plus chemotherapy to treat NSCLC. Opdivo is approved to treat second-line NSCLC, with no restrictions on PD-L1 status, as well as melanoma, renal cell carcinoma (RCC) and classical Hodgkin's lymphoma. Yervoy is approved to treat melanoma...