(Breast Cancer) Verzenio Plus Keytruda: Is It Effective?

From May 29–31, 2020, Dr. Hope S. Rugo presented at the ASCO 2020 Virtual Scientific Program interim analysis results from a Phase 1b clinical trial evaluating the CDK4/6 inhibitor Verzenio (abemaciclib) combined with the PD-1 antibody Keytruda (pembrolizumab) in previously treated patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer.

This Phase 1b trial was an open-label, multi-center study enrolling 28 patients with previously treated HR+, HER2-negative locally advanced or metastatic breast cancer. Patients received Verzenio 150 mg twice daily plus Keytruda 200 mg on a 21-day cycle. The primary endpoint was safety; secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).

The trial was initiated based on confirmed anti-tumor activity of Verzenio monotherapy or aromatase inhibitor plus fulvestrant in HR+, HER2-negative locally advanced or metastatic breast cancer patients, as well as preclinical data demonstrating anti-tumor activity of Verzenio plus Keytruda in mouse models.

Results:

Primary endpoint safety: Grade 3–4 adverse events included neutropenia (29%, N=8), AST elevation (18%, N=5), diarrhea (11%, N=3), and ALT elevation (11%, N=3). Safety findings were consistent with previously known Verzenio adverse events; no new safety signals were identified.

Secondary endpoints:

• Objective response rate (ORR): 29%
• Disease control rate (DCR): 82%
• Median PFS: 8.9 months
• Median OS: 26.3 months

Conclusion: Based on the interim analysis, Dr. Rugo concluded that Verzenio plus Keytruda showed numerically favorable ORR, PFS, and OS compared to historical Verzenio monotherapy data, though no statistically significant difference was confirmed.

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Source: A phase Ib study of abemaciclib in combination with pembrolizumab for patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer (MBC) (NCT02779751): Interim results. (2020 ASCO Virtual Scientific Program, Abstract No: 1051)

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