March 20, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Eli Lilly and Company announced today that its MONARCH 2 Phase III clinical trial of abemaciclib for breast cancer met its primary endpoint of progression-free survival (PFS).
Abemaciclib was being evaluated in combination with fulvestrant in patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer patients who have relapsed or progressed after endocrine therapy. The addition of the drug to fulvestrant showed statistically significant improvement in PFS compared to the control arm, which consisted of a placebo plus fulvestrant.
“We are excited about the outcome of our first Phase III study for abemaciclib,” said Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology, in a statement. “These data are 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. This is another example of Lilly’s commitment to delivering breakthrough treatments and improving outcomes for patients with cancer.”
The drug is also being evaluated in lung cancer, other categories of breast cancer, and in combination with other drugs. Abemaciclib is an oral cell cycle inhibitor. It is designed to inhibit cancer cell growth by inhibiting cyclin-dependent kinases, CDK 4 and CDK 6. The U.S. Food and Drug Administration (FDA) granted the drug Breakthrough Therapy Designation in 2015.
Other drugs in that class include Pfizer ’s Ibrance and Novartis AG ’s Kisqali.
John Carroll, writing for Endpoints News, says, the drug’s “late arrival could carry a heavy penalty. According to the key trial design, Lilly’s drug was restricted to patients who have not previously been treated with a CDK 4/6 drug. If that makes its way to the label, Lilly’s treatment would not be allowed for any patients who had been treated with either Pfizer’s Ibrance or Novartis’s ribociclib (LEE011). And with both of those drugs on the market ahead of Lilly, that could significantly shrink its market reach.”
The company plans to submit a new drug application (NDA) for abemaciclib in the second quarter of 2017. It also plans to submit another application for MONARCH 2 in the third quarter of 2017.
Seamus Fernandez, an analyst with Leerink, wrote in a note to investors this morning, “The company has the ‘data package ready to go’ and will submit an NDA for single-agent abemaciclib in 2Q17 based on the MONARCH-1 study; the package will include data on response rate (RR), PFS and OS (overall survival). An additional application submission for MONARCH-2 is expected in 3Q17. Management also confirmed that the MONARCH-3 study, which is in combination with letrozole, is expected to have an interim analysis in 2Q and the final readout is expected before the end of 2017.”
Ibrance has been on the market two years. Kisqali hit the market about six months ago.
Timothy Anderson, an analyst with Bernstein’s, wrote a note to clients today as well. As reported by Reuters, “With Monarch-2 supportive of the drug’s effectiveness and/or assuring on its long-term safety profile, the odds of monotherapy approval have improved.”
Bernstein’s forecast for the drug is $1.3 billion by 2021, but that prediction is based on the drug entering the market third without being able to differentiate itself from its two competitors. If, Anderson noted, Lilly had detailed data showing the drug was more competitive, that number go up significantly. For example, a higher relative response rate, a longer duration of response, and good tolerability despite frequent diarrhea.
Lilly plans to release detailed data at a future medical conference, which most analysts expect will be the American Society of Clinical Oncology (ASCO) meeting held in June.
