Lilly’s breast cancer drug meets primary endpoint
pharmafile | March 21, 2017 | News story | Manufacturing and Production, Research and Development | CDK 4/6 inhibitors, Eli Lilly, abemaciclib
Eli Lilly has announced that its trial of abemaciclib, in combination with fulvestrant, had met its primary endpoint of progression-free survival (PFS) in a Phase 3 trial. The drug is one of a new generation of CDK 4/6 inhibitors, and should, all being well, follow Pfizer and Novartis’ drugs onto the market.
The trial involved 669 patients who received a twice daily dose of abemaciclib or a placebo, alongside fulvestrant – a hormonal drug used to treat breast cancer in women who have been through the menopause.
The trial found a “statistically significant improvement in PFS when compared to the control arm of placebo plus fulvestrant”. Full details of the trial were not released on the results.
“We are excited about the outcome of our first Phase 3 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, Senior Vice President, 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.”
The trial will very likely see the drug progress through onto the market to compete with Pfizer’s Ibrance and Novartis’ recently-approval Kisqali. It means that Lilly are able to recover after choosing to continue with its study passed an interim analysis checkpoint – suggesting that efficacy was not strong enough to push for an early approval.
Lilly is also exploring abemaciclib’s potential as a form of treatment in lung cancer, with Phase 3 trials on-going.
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