Lilly reports positive new clinical data for breast cancer drug abemaciclib

Lilly has announced the findings of a phase III clinical trial showing the safety and efficacy of its new breast cancer drug abemaciclib.

Data from the MONARCH 2 trial the primary endpoint of progression-free survival, showing that a regimen of abemaciclib in combination with fulvestrant can benefit women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer who have relapsed or progressed after endocrine therapy.

The addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in survival rates when compared to the control arm of fulvestrant plus placebo, with an adverse event profile that was consistent with previous studies of abemaciclib.

Lilly will utilise the positive findings of the MONARCH 1 and MONARCH 2 trials to support future regulatory submissions for the drug planned for later this year.

Dr Levi Garraway, senior vice-president for global development and medical affairs at Lilly Oncology, said: "This data is an important milestone in our goal of bringing abemaciclib to patients with advanced breast cancer, and we look forward to our upcoming conversations with regulators."

The drug is also being studied in another trial, MONARCH 3, assessing a combination of abemaciclib plus a nonsteroidal aromatase inhibitor.

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