EC approves Opdivo + Yervoy as first-line treatment for HCC

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The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.

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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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