(Breast Cancer) Verzenio Plus Keytruda: Is It Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
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.
Disclaimer: Medical Supporter translates overseas clinical trial data and pharmaceutical information for informational purposes only. This does not constitute encouragement to participate in clinical trials or use any new drug. Translation materials are for reference only. Please consult your healthcare provider for medical decisions.
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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