Xinhua News Agency, Beijing (reporter Wang Kala) At the ongoing 2023 European Society for Medical Oncology (ESMO) Annual Meeting, Eli Lilly and Company announced the 5-year results of the pre-planned analysis of the Phase III study monarchE of abemaciclib tablets. Continuous adjuvant treatment with abemaciclib for 2 years still brought sustained benefits to patients after the end of treatment, reducing the 5-year long-term recurrence risk by 32% and increasing the invasive disease-free survival rate by 7.6%.
The data announced by Eli Lilly this time includes the results of a pre-specified analysis, with a median follow-up time of 4.5 years for patients. All patients have completed the course of abemaciclib, and more than 80% of the patients have been followed up for at least two years after the completion of treatment. In the intent-to-treat population, the risk of developing invasive disease was reduced by 32%. The absolute benefits in invasive disease-free survival and distant relapse-free survival further increased at the 5-year mark, improving by 7.6% and 6.7%, respectively, compared to the control group, showing improvement over the 2-year, 3-year, and 4-year marks. Since most invasive disease-free survival events were also distant relapse-free survival events, there was continued benefit in distant relapse-free survival as well, with abemaciclib reducing the risk of distant recurrence or death by 32.5%.
It is estimated that 90% of breast cancer cases are diagnosed at an early stage. The most common subtype is HR+, HER2-, which accounts for approximately 70% of all breast cancer patients. Although the prognosis for patients with HR+, HER2- early-stage breast cancer is generally favorable, some patients may still experience recurrence or distant metastasis, leading to an incurable condition. The risk of recurrence in high-risk early-stage breast cancer patients is three times higher than in non-high-risk patients. These patients face a higher risk of recurrence within the first two years of endocrine therapy.
Abemaciclib is currently the only approved CDK4/6 inhibitor for the treatment of HR+, HER2-, lymph node-positive, high-risk early breast cancer patients. It has been approved for adjuvant treatment in certain specific HR+, HER2- breast cancer patients, as well as for the treatment of advanced or metastatic patients.
Proofread by Liu Jun