Merck (MRK - Analyst Report) recently presented preliminary data on its oncology candidate, lambrolizumab (MK-3475), from an ongoing phase Ib expansion study. The study is being conducted in patients with advanced (inoperable and metastatic) melanoma.
The multi-center, single-arm open-label study is being conducted to evaluate the safety and efficacy of the candidate. Three dosing regimens are being evaluated. The overall confirmed response rate was 38% across all the dosing regimens with the highest overall response rate being 52% in the 10 mg/kg Q2W dosing regimen.
Merck said that the response rates for Yervoy (ipilimumab)-pretreated and Yervoy-naïve patients were similar. Yervoy is Bristol-Myers Squibbs’ (BMY - Analyst Report) treatment for unresectable or metastatic melanoma.
These results were presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
Merck said that it intends to move lambrolizumab into late-stage studies for advanced melanoma and non-small cell lung cancer in the third quarter of 2013. While the advanced melanoma phase III study will be conducted in Yervoy-naïve patients, the non-small cell lung cancer study will be a phase II/III study.
Merck recently moved lambrolizumab into a global, randomized phase II study in treatment-experienced advanced melanoma patients. Lambrolizumab is also being evaluated for the treatment of triple negative breast, metastatic bladder cancer and head & neck cancer.
We note that Merck received breakthrough therapy designation for lambrolizumab from the FDA earlier this year for the advanced melanoma indication. The designation, which was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act, is granted to potential new treatments for serious or life-threatening diseases where the initial clinical data shows that the treatment has the potential to demonstrate substantial improvement on one or more clinically significant endpoints compared to existing therapies.
Merck as well as Bristol-Myers currently carry a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Santarus, Inc. and Salix Pharmaceuticals, Ltd. (SLXP - Analyst Report). Both are Zacks Rank #1 (Strong Buy) stocks.