Opdivo nivolumab: Phase III final data

Final data from 423 patients with advanced NSCLC and >=5% PD-L1 tumor expression in the open-label, international Phase III CheckMate -026 trial showed that first-line treatment with

In patients with >=50% PD-L1 expression, Opdivo led to a PFS hazard ratio of 1.07 and an OS hazard ratio of 0.9. BSM said the trial “was not designed or stratified to provide meaningful conclusions” for subgroups, including patients with >=50% PD-L1 expression. The trial enrolled 541 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. Data were presented at the European Society for Medical Oncology meeting in Copenhagen. BMS previously reported that Opdivo missed the primary endpoint of improving PFS as assessed by an independent radiology review committee in patients with >=5% PD-L1 tumor expression vs. chemotherapy (see BioCentury, Aug. 8). ...