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Lilly’s (LLY) Verzenio Fails in Phase III Lung Cancer Study


The series of setbacks continues for Eli Lilly and Company LLY as the company announced that its phase III JUNIPER study failed to meet the primary endpoint. The study was evaluating Verzenio in advanced non-small lung cancer ("NSCLC") with KRAS mutation. Shares fell 1% on Tuesday after the announcement.

Verzenio received approval for treating metastatic breast cancer last month in patients where the disease progressed after platinum-based chemotherapy.

Lilly’s shares are up 17.1% so far this year, slightly underperforming the industry’s gain of 18.3% in the period.

The JUNIPER study compared Verzenio with Roche/Astella Pharma’s Tarceva in stage IV lung cancer patients who have progressed after platinum-based chemotherapy and may have received an additional systemic therapy. The study did not meet its primary endpoint of overall survival. However, it showed some improvement in secondary endpoints of progression-free survival in patients and overall response rate.

A successful completion of the study would have given Verzenio an edge over Pfizer Inc's PFE Ibrance and Novartis AG's NVS Kisqali, which are only approved for breast cancer.

Lilly is currently evaluating Verzenio in multiple studies in NSCLC, including a combination therapy with Merck’s MRK Keytruda, an anti-PD-1 therapy.

We remind investors that Lilly faced two major setbacks in the past one year. These included a complete response letter from the FDA for its rheumatoid arthritis candidate, baricitinib, in April 2017 and a failed study on Alzheimer's candidate solanezumab in November last year.

Meanwhile, Lilly is also facing generic competition due to loss of exclusivity for several key drugs including Zyprexa and Cymbalta. Moreover, Alimta is facing competition from immuno-oncology agents in the United States.

Given the recent setbacks, generic competition and absence of drugs nearing approval, Lilly may struggle to maintain the growth pace that it has shown so far this year.

Lilly carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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