EMA validates application for Opdivo + Yervoy to treat NSCLC patients who have tumor mutational burden.- BMS.

Bristol-Myers Squibb Company announced that the European Medicines Agency (EMA) validated a type II variation application for the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for treatment in adult patients with first-line metastatic non-small cell lung cancer (NSCLC) who have tumor mutational burden (TMB) greater than 10 mutations/megabase (mut/Mb). Validation of the application confirms the submission is complete and begins the EMA�s centralized review process.

Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, commented, �Europe has one of the highest incidence rates of advanced lung cancer, currently accounting for 20% of all cancer deaths. The Opdivo plus low-dose Yervoy combination has the potential to offer first-line NSCLC patients with TMB greater tan 10 mut/Mb a chemotherapy-sparing I-O/I-O regimen. The validation of our application by the EMA is a step forward in the regulatory review process, and we will continue to work with urgency to bring precision immunotherapy to patients with lung cancer in the European Union.� The application is based on data from Part 1 of CheckMate -227, a global Phase III study evaluating Opdivo-based regimens versus chemotherapy in patients with first-line advanced NSCLC across squamous and non-squamous histologies. Initial results from this study were presented at the American Association for Cancer Research Annual Meeting in April 2018 and simultaneously published in The New England Journal of Medicine.