A comparison of the intent-to-treat population at eight years of follow-up with MONARCH 3 revealed that women taking Verzenio and an AI had a median OS of more than 5.5 years, which was 13.1 months higher than the control arm
A product shot of Verzenio 200mg tablets. (Credit: Eli Lilly and Company)
Eli Lilly and Company said that its Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) failed to show positive results in the final overall survival (OS) analysis of the Phase 3 MONARCH 3 certain breast cancer trial.
The late-stage study assessed the Verzenio combination against an AI alone as initial endocrine-based therapy for post-menopausal patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced, or metastatic breast cancer.
Verzenio is an oral twice-daily tablet, currently approved for patients with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting.
A comparison of the intent-to-treat (ITT) population at eight years of follow-up with MONARCH 3 revealed that women taking Verzenio and an AI had a median OS of more than 5.5 years, which was 13.1 months higher than the control arm.
However, statistical significance was not reached for the OS outcome based on eight years of follow-up.
For women with visceral organ metastases, including those whose breast cancer has spread to the liver or lungs, findings demonstrated a median OS of over five years with an increase of 14.9 months in the Verzenio arm compared to the control arm.
However, the OS results for this subgroup were not statistically significant either, Lilly said.
Lilly chief medical officer David Hyman said: “With a median OS of more than 5.5 years in patients treated with Verzenio in this study, these data further support the role of Verzenio in the survival of women with HR+, HER2- metastatic breast cancer.
“We remain confident in the differentiated profile of Verzenio and we look forward to sharing these results with the clinical community at SABCS and getting their perspective on these data and relevance for clinical practice.”
In an interim analysis in 2017, MONARCH 3 achieved its primary endpoint of progression-free survival (PFS), leading to global regulatory approvals for this indication in 2018.
In a separate development, Lilly has announced the availability of Zepbound (tirzepatide) injection in the US for adults living with obesity or those who are overweight and have weight-related medical issues.
Approved by the US Food and Drug Administration (FDA) last month, the injection is available in 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg via a prescription.