BMS Receives Positive CHMP Opinion Recommending Opdivo for the Treatment of Squamous Cell Cancer of

Bristol-Myers Squibb Company has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo as monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). This is the first CHMP positive opinion to recommend a PD-1 inhibitor for this type of treatment for SCCHN. Opdivo is already approved by the EC for six indications in four distinct tumor types.

"Nearly half of all patients with squamous cell cancer of the head and neck relapse within two years of treatment and limited advancements have been made in the last 10 years, underscoring the critical need for new treatment options for patients affected by this devastating illness," commented Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb. "We are very pleased that the CHMP has recommended the approval of Opdivo for adults with squamous cell cancer of the head and neck who have progressed on or after platinum-based therapy and look forward to working with the EC as they review this treatment as a potential option for patients in the EU."

The CHMP adopted a positive opinion based on results from CheckMate -141, a pivotal Phase 3 open-label, randomized trial, that evaluated the overall survival (OS) of Opdivo in previously treated patients with SCCHN following platinum-based therapy compared to investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab) in the adjuvant, primary, recurrent or metastatic setting. Based on a planned interim analysis, this trial was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee concluded the study met its primary endpoint of OS superiority in patients receiving Opdivo compared to investigator’s choice of therapy. Overall survival data from CheckMate -141 were first presented at the 2016 Annual Meeting of the American Association for Cancer Research. The safety profile of Opdivo in CheckMate -141 was consistent with prior studies in other tumors.