August 10, 2016
By Alex Keown, BioSpace.com Breaking News Staff
INDIANAPOLIS – Despite the interim goal efficacy failure of progression free survival for a late stage breast cancer therapy, Eli Lilly said it will continue the trial, following the recommendation of an independent data monitoring committee.
The Phase III Monarch 2 trial comparing the combination treatment of abemaciclib plus fulvestrant against AstraZeneca ’s Faslodex (fulvestrant) for the treatment of women with Her-2 positive breast cancer will continue through early 2017, the company announced this morning. The trial will continue despite failing to meet what company officials called “stringent criteria” for the interim analysis of the drug study. That criteria was progression free survival. The company said it remains hopeful the combination treatment will ultimately offer improved outcomes for cancer patients. The drug is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy.
That hope seems to have extended to company investors, as Eli Lilly stock only dropped about 1.5 percent in early trading this morning to $79.67 per share. While still slightly down from Tuesday’s closing price of $81.50 per share, the stock has inched back up to $80.40 per share.
Abemaciclib is part of a class of drugs developed to inhibit the CDK 4 and CDK 6 proteins.
The Monarch study included 669 patients who received the treatment or placebo orally every 12 hours on a continuous dosing schedule. Each of the enrolled patients had experienced disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for metastatic disease.
Even if Lilly’s hopes are met following the continuation of the trial, the company’s combination treatment would face tough competition in the breast cancer market if it were approved for marketing by the U.S. Food and Drug Administration. Lilly’s combination treatment is in the same class of drug as Pfizer ’s recently approved Ibrance, which has shown strong sales since its 2015 approval. Analysts predict the drug could ultimately earn $3 to $5 billion annually.
Another drug that drug in the same class that could crowd the market for abemaciclib is Novartis ’ ribociclib. In May, a Phase III trial for ribociclib in combination letrozole was halted early by an independent data monitoring committee due to clinically meaningful improvement. Earlier this month ribociclib received breakthrough therapy designation as a first-line treatment for HR+ and Her2- breast cancer.
Breast cancer in women is the second most common type of cancer in the United States. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.
In addition to the Monarch 2 study, Eli Lilly is evaluating abemaciclib in multiple trials for the treatment of breast cancer. Last year, the FDA granted abemaciclib breakthrough therapy status for breast cancer treatment.Abemaciclib is also being studied for the treatment of lung cancer.
