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Early Abemaciclib Data Not Sufficient to Halt Phase III Breast Cancer Trial

Jason M. Broderick @jasoncology
Published: Wednesday, Aug 10, 2016

Richard Gaynor, MD

Richard Gaynor, MD

The phase III MONARCH 2 study assessing abemaciclib in HR-positive, HER2-negative advanced breast cancer will continue after the CDK4/6 inhibitor did not meet the efficacy criteria at an interim analysis required to stop the trial early, according to Eli Lilly and Company, the manufacturer of the treatment.

The international, double-blind phase III MONARCH 2 trial randomized 669 patients in a 2:1 ratio to abemaciclib plus fulvestrant or fulvestrant alone. Patients had progressed during or within 1 year of receiving endocrine therapy in the neoadjuvant or adjuvant setting, or during frontline endocrine treatment for metastatic disease. Individuals were excluded from enrollment if they were administered chemotherapy in the metastatic setting. The primary endpoint for the trial is progression-free survival (PFS).

"We had stringent criteria set for this interim analysis and we look forward to receiving the final MONARCH 2 results in the first half of 2017," Richard Gaynor, MD, senior vice president, product development and medical affairs for Lilly Oncology, said in a statement. "We remain optimistic that treatment with abemaciclib, in combination with fulvestrant could offer improved outcomes for patients."

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