Eli Lilly and Co's combination of its experimental breast cancer drug and another widely used treatment slowed disease progression in patients who relapsed or did not benefit enough when treated with anti-oestrogen therapy, says a Reuters Health report.
In August, an independent data monitoring committee recommended the late-stage study continue without modification, even though interim evaluation suggested the combination treatment was not delaying cancer progression.
Lilly's drug, abemaciclib, is part of the same new class of breast cancer treatments as Pfizer Inc's Ibrance, and Novartis AG's newly approved Kisqali. The study, named Monarch-2, compared combined use of abemaciclib and anti-oestrogen therapy fulvestrant with fulvestrant alone.
Lilly said that data showed the addition of abemaciclib, which is also being evaluated for lung cancer, resulted in a statistically significant improvement in progression-free survival.
The US drugmaker is also evaluating the drug as a single agent in breast cancer patients who have not derived enough benefit from prior treatments, and multiple other studies are testing abemaciclib in combination with other drugs.
Lilly said it planned to submit an application to market abemaciclib as a monotherapy in the second quarter, and as a combination therapy in the third quarter. If approved, abemaciclib will be the third entrant to the US market, more than two years after Ibrance, and just over six months behind Kisqali.
Lilly said it would provide detailed data from the study at a future medical conference, which analysts predict is likely at the American Society of Clinical Oncology (ASCO) meeting in June.
[link url="http://www.reuters.com/article/us-lilly-syudy-idUSKBN16R0YS"]Reuters Health report[/link]