- Eli Lilly reported Monday its experimental breast cancer drug abemaciclib succeeded in an important Phase 3 study, positioning the Indianapolis pharma to file for approval of the CDK 4/6 inhibitor as both a single agent and a combination therapy later this year.
- The so-called MONARCH 2 trial paired abemaciclib with the commonly used anti-estrogen drug fulvestrant, testing the combo in patients with advanced breast cancer that did not respond to endocrine therapy.
- Treatment with the two drugs led to a statistically significant improvement in progression-free survival, although Lilly did not disclose further details. Lilly hopes to compete with Pfizer's fast-growing Ibrance (palbociclib) and Novartis' recently approved Kisqali (ribociclib).
Ibrance, Kisqali and Lilly's abemaciclib are all part of the same new class of drugs, known as CDK 4/6 inhibitors. Promising efficacy, coupled with Ibrance's success to date, has sparked interest in the commercial prospects of the class.
Lilly sees abemaciclib as a key driver of growth through 2023, along with drugs like the diabetes medicines Trulicity (dulaglutide) and Jardiance (empagliflozin). Novartis beat Lilly as second to market, though, scoring an approval for Kisqali earlier this month, stiffening the competition abemaciclib will face if approved.
Last year, Lilly had opted to continue the MONARCH-2 trial past an interim analysis checkpoint, suggesting the drug had not shown enough efficacy to stop the trial early. That delay pushed a readout into 2017, giving Novartis a window to move ahead.
Similar to Ibrance and Kisqali, abemaciclib is aimed first at breast cancer patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer that has progressed after treatment with endocrine therapy.
Lilly will disclose detailed results at an upcoming medical meeting and plans to submit a filing for approval of abemaciclib in combination with fulvestrant in the third quarter. Before that though, Lilly will also apply to market abemaciclib as a monotherapy for heavily pre-treated patients with metastatic breast cancer based on a smaller Phase 2 study.
Shares in the Indianapolis drugmaker rose nearly 1% in value in Monday morning trading on the news.