Zhi Tong Cai Jing·2025-05-13 07:43Core Insights - Roche (RHHBY.US) announced statistically significant results from the final overall survival (OS) outcomes of the Phase III APHINITY study for patients with HER2-positive early breast cancer, showing a 17% reduction in death risk for those treated with Perjeta, Herceptin, and chemotherapy compared to those receiving Herceptin, chemotherapy, and placebo [1][2] Group 1 - The APHINITY study was a global, Phase III, randomized, double-blind, placebo-controlled trial involving 4,804 operable HER2-positive early breast cancer patients [1] - The primary endpoint of the study was invasive disease-free survival, with secondary endpoints including cardiac and overall safety, overall survival, and health-related quality of life [1] Group 2 - Ten-year survival rates showed that patients receiving the Perjeta regimen had a survival rate of 91.6%, compared to 89.8% for those receiving Herceptin, chemotherapy, and placebo (HR=0.83, 95% CI: 0.69-1.00, p=0.044) [2] - In the pre-specified subgroup of lymph node-positive patients, the death risk was reduced by 21% (HR=0.79, 95% CI: 0.64-0.97) [2] - The previously reported benefits in invasive disease-free survival were maintained (HR=0.79, 95% CI: 0.68-0.92), with no observed benefits in the lymph node-negative subgroup [2] - Safety profiles, including cardiac safety, were consistent with previous studies, with no new or unexpected safety signals identified [2]