Opdivo nivolumab: Additional Phase III data

Additional data from the open-label, international Phase III CheckMate -141 trial in 361 patients with SCCHN showed that 3 mg/kg IV Opdivo every 2 weeks led to a median OS, the primary endpoint, of 7.5 months vs. 5.1 months for investigator’s choice of cetuximab, methotrexate or docetaxel (HR=0.7, 97.73% CI: 0.51, 0.96, p=0.0101). Opdivo led to a 1-year OS rate of 36% vs. 16.6% for investigator’s choice. In HPV-positive patients, Opdivo led to a median OS of 9.1 months vs. 4.4 months for investigator’s choice (HR=0.56, 95% CI: 0.32, 0.99). In HPV-negative patients, Opdivo led to a median OS of 7.5 months vs. 5.8 months for investigator’s choice (HR=0.73, 95% CI: 0.42, 1.25). Additionally, in patients with >1% PD-L1 expression, Opdivo led to a median OS of 8.7 months vs. 4.6 months for investigator’s choice (HR=0.55, 95% CI: 0.36, 0.83). In patients with <1% PD-L1 expression, Opdivo led to a median OS of 5.7 months vs. 5.8 months for investigator’s choice (HR=0.89, 95% CI: 0.54, 1.45). The trial enrolled patients with SCCHN who had tumor progression on or within 6 months of platinum therapy in the primary, recurrent or metastatic setting. Data were presented at the American Association for Cancer Research meeting in New Orleans. In January, CheckMate -141 was stopped early after an analysis by an independent DMC showed that Opdivo met the primary endpoint (see BioCentury, Feb. 1). ...