Eli Lilly & Co. said its cancer drug Verzenio delivered a statistically significant and clinically meaningful improvement in overall survival for patients with hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer. The finding comes from the primary overall-survival analysis of the Phase 3 monarchE trial, in which a two-year course of Verzenio combined with standard endocrine therapy was compared with endocrine therapy alone. A seven-year landmark review also showed sustained gains in invasive disease-free survival and distant relapse-free survival, the company added, noting that the safety profile was unchanged from earlier reports. Lilly said the data reinforce a two-year Verzenio regimen as the standard of care for this patient population and will be shared with regulators, presented at an upcoming medical meeting and submitted to a peer-reviewed journal. MonarchE enrolled 5,637 adults at more than 600 centers in 38 countries. All participants have now completed or discontinued the two-year treatment window, providing what Lilly called a mature overview of survival outcomes. Lilly’s stock rose about 1 percent to roughly $736 in early New York trading after the announcement.
$LLY 736.03 up 9 Eli Lilly announced positive topline results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial. Treatment with two years of Verzenio plus endocrine therapy (ET) demonstrated a statistically significant and clinically meaningful
Lilly's Verzenio® (abemaciclib) increases overall survival in HR , HER2-, high-risk early breast cancer with two years of therapy $LLY https://t.co/H00DTAojsh
$LLY Lilly's Verzenio (abemaciclib) increases overall survival in HR+, HER2-, high-risk early breast cancer with two years of therapy https://t.co/Eaw45elZPH