The benefit of adjuvant Verzenio in combination with endocrine therapy continues to deepen with additional follow-up, now demonstrating an absolute improvement in invasive disease-free survival (IDFS) and distance relapse-free survival (DRFS) rates of 6.4% and 5.9% at four years, respectively, in patients with HR+, HER2-, node-positive, high risk early breast cancer

INDIANAPOLIS, Dec. 6, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced updated results from the pivotal Phase 3 monarchE trial of adjuvant Verzenio® (abemaciclib) in combination with standard endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC). These data, which include results for investigational uses in the intent-to-treat (ITT) and Cohort 1 populations, were presented today as an oral presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) and simultaneously published in The Lancet Oncology.

Data include updated results from a prespecified analysis reflecting a median follow-up of 3.5 years, with all patients having now discontinued or completed the two-year Verzenio treatment period. The absolute increase in invasive disease-free survival (IDFS) and distance relapse-free survival (DRFS) continued to deepen in magnitude at four years, to 6.4% and 5.9%, respectively, reflecting improvements from the two- and three-year rates. This IDFS and DRFS benefit was seen across all prespecified subgroups, regardless of Ki-67 score. While overall survival (OS) data remain immature at this time, fewer deaths were observed in the Verzenio-plus-ET arm compared to the ET monotherapy arm (HR=0.929, 95% CI: 0.748, 1.153). There were no new safety findings, and overall results are consistent with the well-established safety profile for Verzenio.

"These results from the monarchE trial provide further evidence of the clinically meaningful benefit that adjuvant Verzenio adds to standard endocrine therapy in patients with high risk early breast cancer, a population with an urgent need to intensify therapy. Moreover, this benefit continues to deepen at four years, well beyond the two-year treatment course with adjuvant Verzenio," said Stephen Johnston, M.D., Ph.D., Professor of Breast Cancer Medicine and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust (London, U.K.) and lead investigator for the monarchE trial.

The monarchE trial (N=5,637) included women and men with HR+, HER2-, node-positive EBC with a high risk of disease recurrence. The ITT population included patients enrolled to both Cohort 1 and Cohort 2, with Cohort 1 (N=5,120) representing 91% of all enrolled patients. Cohort 1 enrolled patients based on high risk clinical pathological factors (≥4 positive axillary lymph nodes [ALN], or 1-3 positive ALN and either Grade 3 disease or tumor size ≥5 cm). Cohort 2 enrolled patients with 1-3 positive ALN and centrally determined Ki-67 score of ≥20% (defined in the study as "Ki-67 high"). Ki-67 is a marker of cellular proliferation. Ki-67 score was also determined centrally in Cohort 1 patients with a suitable sample, but Ki-67 determination was not required for enrollment in this cohort.

At the July 1, 2022 data cutoff, in the ITT population, the risk of developing invasive disease was reduced by 33.6% (HR=0.664, 95% CI: 0.578, 0.762; nominal p