(Breast Cancer) Efficacy of Verzenio + Fulvestrant?

On September 29, 2019, George W. Sledge Jr. published in the medical journal The Lancet the efficacy and safety results of CDK4/CDK6 cyclin-dependent kinase inhibitor Verzenio (abemaciclib) in patients with hormone receptor-positive, HER2-negative breast cancer after endocrine therapy from the MONARCH2 Phase III clinical trial.

The MONARCH2 trial was a multicenter, double-blind Phase III trial that randomized patients with hormone receptor-positive, HER2-negative breast cancer after endocrine therapy (N=669) in a 2:1 ratio. The primary endpoint was progression-free survival (PFS); the secondary endpoint was overall survival (OS).

• Verzenio + fulvestrant group (28-day cycle, Verzenio 150 mg twice daily + fulvestrant 500 mg; N=446)
• Placebo + fulvestrant group (28-day cycle, placebo + fulvestrant 500 mg; N=223)

Patient Characteristics:

Median age — Verzenio group: 59 years (32–91); Placebo group: 62 years (32–87)

Race — Verzenio group: Asian 33.4%, White 53.1%, Other 6.5%; Placebo: Asian 29.1%, White 61.0%, Other 5.8%

ECOG performance status — Verzenio group: ECOG 0: 59.2%, ECOG 1: 39.5%; Placebo: ECOG 0: 61.0%, ECOG 1: 39.0%

Prior therapy before endocrine treatment — Verzenio group: neoadjuvant/adjuvant chemotherapy 59.0%, treatment at metastasis 38.3%; Placebo: neoadjuvant/adjuvant chemotherapy 59.6%, treatment at metastasis 38.1%

Prior aromatase inhibitor therapy — Verzenio group: 70.9% with, 29.1% without; Placebo: 66.8% with, 33.2% without

Metastasis sites — Verzenio group: visceral 54.9%, bone 27.6%, other 16.8%; Placebo: visceral 57.4%, bone 25.6%, other 17.0%

Trial Results: The secondary endpoint median OS was: Verzenio group 46.7 months vs. placebo group 37.3 months. The Verzenio group's death risk was 24.3%, hazard ratio 0.757 — a significant improvement.

Subgroup analysis: Patients with visceral metastases showed a 32.5% reduction in death risk (HR 0.657), an improvement. Patients with bone-only metastases showed a 9.03% reduction in death risk (HR 0.907), an improvement.

Based on MONARCH2 results, George W. Sledge Jr. concluded: In hormone receptor-positive, HER2-negative breast cancer patients after endocrine therapy, CDK4/CDK6 cyclin-dependent kinase inhibitor Verzenio improved overall survival compared to placebo.

Source: The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy — MONARCH 2: A Randomized Clinical Trial. (JAMA Oncol. 2019 Sep 29. doi: 10.1001/jamaoncol.2019.4782.)

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Related Cancer Information

• Breast cancer