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Continuing the Overall Survival Analysis in the MONARCH-2 Trial

George W. Sledge, Jr., MD
Published Online:7:18 PM, Mon December 2, 2019

George W. Sledge, Jr., MD, professor of medicine (oncology), Stanford University Medical Center, discusses the next steps for the phase III MONARH-2 trail following the positive interim analysis results presented during the 2019 European Society of Medical Oncology (ESMO) Congress.

Agents like abemaciclib (Verzenio) have moved into the adjuvant setting and are being studied in large phase III proof-of-concept trials similar to MONARCH-2, according to Sledge. These studies are evaluating outcomes like disease free survival, and overall survival in the early disease setting. The next step for investigators of the MONARCH-2 study is to do longer term follow-up on the patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer who are being treated with CDK4/6 inhibitor abemaciclib plus fulvestrant (Faslodex) in the study.

Sledge also discusses an important way to further develop CDK4/6 inhibitors, which is to look at other important endpoints, like the time to chemotherapy endpoint explored in the MONARCH-2 study. Patients in the control arm of the study demonstrated about a 22-month median time to chemotherapy compared with 50.1 months in the abemaciclib plus fulvestrant arm. The increase was significant and valuable for patients who want to forgo chemotherapy, says Sledge.
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