ARTICLE | Clinical News

Opdivo nivolumab: Phase III data

August 8, 2016 7:00 AM UTC

Top-line data from the open-label, international Phase III CheckMate -026 trial in 541 patients with advanced NSCLC showed that first-line treatment with 3 mg/kg IV Opdivo every 2 weeks missed the primary endpoint of improving PFS as assessed by an independent radiology review committee in patients with >=5% PD-L1 tumor expression vs. investigator’s choice of chemotherapy. The trial enrolled PD-L1-positive patients who had no prior systemic treatment for advanced NSCLC. In the investigator’s choice cohort, squamous NSCLC patients received gemcitabine plus cisplatin, gemcitabine plus carboplatin or paclitaxel plus carboplatin; and non-squamous NSCLC patients received Alimta pemetrexed plus cisplatin or Alimta plus carboplatin. Opdivo is also in the Phase III CheckMate -227 trial evaluating monotherapy or combination therapy with Yervoy ipilimumab or platinum-doublet chemotherapy in patients with chemotherapy-naive stage IV or recurrent NSCLC. ...