FDA Approval Announcement
INDIANAPOLIS, Oct. 13, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor‑positive (HR+), human epidermal growth factor receptor 2‑negative (HER2‑), node‑positive, early breast cancer (EBC) at high risk of recurrence and a Ki‑67 score of ≥20% (as determined by an FDA‑approved test). Ki‑67 is a marker of cellular proliferation.Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
Company Statement
Jacob Van Naarden, senior vice president, CEO of Loxo Oncology at Lilly and president of Lilly Oncology, stated that the Verzenio clinical program has demonstrated a differentiated CDK4/6 inhibitor profile, and the monarchE trial data represent an important advance for patients in need of new therapies. Lilly looks forward to further expanding the use of Verzenio in the adjuvant setting as data mature.
Phase 3 monarchE Trial Design
The monarchE trial is a randomized (1:1), open‑label, two‑cohort, multicenter study in adult men and women with HR+ HER2‑, node‑positive, resected EBC at high risk of recurrence.
Patients received 2 years of Verzenio 150 mg twice daily plus standard endocrine therapy (ET) or ET alone.
Adjuvant ET was continued for up to 5–10 years per physician recommendation.
Primary endpoint: invasive disease‑free survival (IDFS).
Efficacy Results
The trial met its primary endpoint, with statistically significant improvement in IDFS for Verzenio plus ET versus ET alone in the intent‑to‑treat (ITT) population.
Prespecified Ki‑67 ≥20% Subgroup Analysis (N=2,003)
Included patients with:
≥4 positive axillary lymph nodes, or
1–3 positive nodes plus Grade 3 disease and/or tumor size ≥5 cm,and Ki‑67 score ≥20%.
HR for IDFS: 0.643 (95% CI: 0.475–0.872; p=0.0042)
Post‑hoc analysis with extended follow‑up:
37% reduction in risk of breast cancer recurrence or death (HR=0.626; 95% CI: 0.49–0.80)
3‑year absolute IDFS benefit: 7.1%
IDFS events: 104 in Verzenio‑ET group vs. 158 in ET‑alone group
Overall survival data were immature and follow‑up is ongoing.
