Phase III Opdivo + Yervoy trial meets primary endpoint in advanced HCC

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The phase III CheckMate-9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma who have not received prior systemic therapy met its primary endpoint of improved overall survival, compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis.

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The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) from Bristol Myers Squibb for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma, based on results from the phase III CheckMate-9DW trial. The CHMP opinion will now be reviewed by the European Commission.
Bristol Myers Squibb announced results of an analysis from the three-arm phase III CheckMate-8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo monotherapy across all lines of therapy, including first-line, for the treatment of microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer. At a median follow-up of 47 months, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual-primary endpoint of progression-free survival as assessed by Blinded Independent Central Review versus Opdivo monotherapy (HR 0.62; 95% CI 0.48–0.81; P = 0.0003).

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