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Lilly's Breast Cancer Combo Drug Phase III Results Positive

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Eli Lilly and Company (LLY - Free Report) recently announced that a phase III combination study evaluating its pipeline candidate abemaciclib in advanced breast cancer, met the primary endpoint of progression-free survival (PFS).

The double-blind MONARCH 2 phase III study evaluated abemaciclib, a CDK 4/6 inhibitor,plus fulvestrant  versus placebo with fulvestrant for the treatment of HR+/HER2- locally advanced or metastatic breast cancer. Data from the study showed that the addition of abemaciclib to fulvestrant led to a statistically significant improvement in PFS when compared to placebo plus fulvestrant.

Lilly’s shares have risen 14.2% so far this year, compared with a 7.0% increase for the Zacks classified Large-Cap Pharma industry.

Abemaciclib has received Breakthrough Therapy designation for the treatment of patients with refractory HR+ advanced or metastatic breast cancer.

We remind investors that in August last year, an independent Data Monitoring Committee (DMC) had recommended continuing the MONARCH 2 study without modification. The decision was based on a provisional analysis of the study as the interim efficacy criteria were not met.

Abemaciclib was also evaluated as a monotherapy in the MONARCH 1 phase II study in women with refractory metastatic breast cancer. On the basis of data from this study, Lilly expects to file a new drug application (NDA) for approval as a breast cancer monotherapy in the second quarter of this year. Meanwhile, it will file a separate application for combination treatment on the basis of MONARCH 2 in the third quarter of this year.

Other than these MONARCH studies, MONARCH 3 phase III combination study evaluating  abemaciclib in combination with a nonsteroidal aromatase inhibitor for the treatment of HR+, HER2- advanced breast cancer and phase II MONARCH study, monarcHER, evaluating abemaciclib plus trastuzumab (with or without fulvestrant) in HR+, HER2+ locally advanced or metastatic breast cancer are ongoing. The company is also evaluating the candidate in a phase III study for lung cancer.

Other available CDK4/6 inhibitors in the market include Pfizer, Inc.’s (PFE - Free Report) Ibrance and Novartis AG’s (NVS - Free Report) newly approved Kisqali. Abemaciclib, if approved would help Lilly to gain substantial foothold in the growing breast cancer market. Per the American Cancer Society, breast cancer is likely to impact 2,50,000 women in 2017. It is anticipated that up to one-third of the early stage breast cancer patients will develop metastatic disease subsequently.

Lilly currently carries a Zacks Rank #3 (Hold). A better-ranked large-cap pharma stock worth considering is GlaxoSmithKline plc (GSK - Free Report) , carrying a Zacks Rank #2 (Buy). You can seethe complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Glaxo have rallied 9.9% this year so far while estimates for 2017 and 2018 have improved by 4.5% and 2.9%, respectively, in the past 60 days.

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