Lilly shares positive Verzenio data as adjuvant early breast cancer therapy

Eli Lilly (Lilly) has shared its latest results from the pivotal phase 3 monarchE trial of Verzenio (abemaciclib) adjuvant in combination with standard endocrine therapy (ET) for patients with high risk early breast cancer (EBC).

The adjuvant treatment is specifically for those diagnosed with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk EBC.

The results, which included data regarding investigational uses in the intent-to-treat (ITT) and cohort 1 populations, have been published in The Lancet Oncology and were also presented at the 2022 San Antonio Breast Cancer Symposium (SABCS).

The monarchE phase 3 global, randomised, open-label, two cohort, multicentre study enrolled adult women and men diagnosed with HR+, HER2-, node-positive resected EBC with clinical and pathological features consistent with a high risk of disease recurrence.

The trial involved a total of 5,637 patients who were randomised to receive two years of Verzenio, dosed at 150mg twice daily alongside the physician's choice of standard ET, or standard ET alone.

The company stated ‘the benefit of adjuvant Verzenio in combination with ET continues to deepen with additional follow-up, now demonstrating an absolute improvement in invasive disease-free survival and distance relapse-free survival rates of 6.4% and 5.9% at four years, respectively, in patients with HR+, HER2-, node-positive, high risk early breast cancer’.

Included in its findings were 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 treatment period using Verzenio.

Although, at this time, overall survival data is still immature, fewer deaths were observed in the Verzenio-plus-ET arm compared to the ET monotherapy arm. In addition, there were no new safety findings noted, while overall results remain consistent with the established safety profile for Verzenio.

Professor Stephen Johnston, lead investigator for the monarchE trial and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, London, said: "These results from the monarchE trial provide further evidence of the clinically meaningful benefit that adjuvant Verzenio adds to standard ET 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."

According to GLOBOCAN, breast cancer has now surpassed lung cancer as the most commonly diagnosed cancer worldwide. Almost 90% of all breast cancers are identified at an early stage, and despite the prognosis for HR+, HER2- EBC being generally positive, 20% of patients will experience recurrence potentially reaching incurable metastatic disease.

Around two to three years post-diagnosis is when the risk of recurrence is at its highest, particularly in those with node-positive, high risk EBC.