Lilly's Verzenio falls short in long-term OS analysis

05 Dec 2023
firstwordpharma.com
Clinical ResultASCOPhase 3Phase 1
Eli Lilly reported Tuesday that its CDK 4/6 blocker Verzenio (abemaciclib) combined with aromatase inhibitor therapy came up short in the final overall survival (OS) analysis of the Phase III MONARCH 3 breast cancer trial. Nevertheless, study investigator Stephen Johnston said the combination delivered "a meaningful survival difference" in both the intent-to-treat (ITT) population of women with HR+/HER2- metastatic breast cancer and those at even higher risk due to visceral disease.
An interim analysis in 2017 had shown that MONARCH 3 met its primary endpoint of progression free survival (PFS), leading to global regulatory approvals for this indication which followed in the months after. The trial randomised 493 postmenopausal women with HR+/HER2- advanced breast cancer to receive Verzenio plus aromatase inhibitor therapy, or aromatase inhibitor therapy alone. Eli Lilly's drug was associated with a 46% reduction in the risk of progression or death in patients receiving initial therapy for metastatic disease, according to data reported in 2017.
Benefit of 13.1 months
The latest findings, which are due to be presented at the San Antonio Breast Cancer Symposium (SABCS), showed that women taking Verzenio and an aromatase inhibitor had a median OS of more than 5.5 years – or 13.1 months more than the control arm in the ITT population. However, Eli Lilly said that statistical significance for the OS outcome – based on eight years of follow-up – was not reached.
Meanwhile, for women with visceral organ metastases, including those whose breast cancer has spread to the liver or lungs, data showed a median OS of more than 5 years, with an increase in median OS of 14.9 months in the Verzenio arm compared to controls. However, the OS results for this subgroup were not statistically significant either, the company said.
"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," remarked Eli Lilly chief medical officer David Hyman.
SERD combo data
The company also plans to share updated results at SABCS from the Phase I EMBER study evaluating its SERD drug imlunestrant, both alone and in combination with Verzenio, with or without an aromatase inhibitor, in patients with ER+/HER2- advanced breast cancer. It said that with 5.5 months longer follow-up from the last disclosure, imlunestrant plus Verzenio, with or without an aromatase inhibitor, resulted in an objective response rate (ORR) of 62% and 32%, respectively, and a clinical benefit rate (CBR) of 79% and 71%, respectively.
Data from the trial unveiled last year at the American Society of Clinical Oncology (ASCO) meeting showed that imlunestrant monotherapy was associated with an ORR of 8% and CBR of 40.4% in evaluable patients with advanced breast cancer.
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