Just a week after Novartis scored a key approval for its CDK 4/6 cancer drug, Eli Lilly is announcing that its long-awaited Phase III readout for its rival drug abemaciclib looks good. We won’t get the data until later, but the pharma giant says its MONARCH-2 trial comes with positive progression-free data on advanced hormone-receptor-positive, HER2 negative breast cancer.
Investigators compared abemaciclib combined with fulvestrant to fulvestrant alone. And the data set up an FDA filing sometime in the next three months.
If it’s successful, Lilly will still be jumping into the CDK 4/6 game far behind Pfizer, which was first to the market with Ibrance, and Novartis’ ribociclib, now being marketed as Kisqali.
Lilly had been keeping its fingers crossed that it could get the positive data it needed in an interim analysis, but disappointed investors last summer with the news that it would need to go all the way to the end. Now, with a breakthrough drug designation, Lilly will do everything it can to cut the review cycle short so it can hit the market ASAP.
But its 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 patient 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.
Leerink’s Seamus Fernandez fleshed out Lilly’s timeline this morning, including a likely ASCO presentation, after talking to execs. He noted:
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. Mgmt 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.
“We are excited about the outcome of our first Phase III study for abemaciclib. 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,” said Levi Garraway, SVP, global development and medical affairs, Lilly Oncology. “This is another example of Lilly’s commitment to delivering breakthrough treatments and improving outcomes for patients with cancer.”
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