Keytruda Is Top Therapy for Melanoma in US
Why the FDA Granted Priority Review for Merck's Keytruda
What is Keytruda?
As discussed earlier, Keytruda is an immuno-oncology drug from Merck and Co (MRK). It is a human programmed death receptor protein 1 (PD-1) blocking antibody. This drug reduces tumor growth by blocking the interaction between PD-1 and its ligands. The drug is indicated for the treatment of non-small cell lung cancer as well as melanoma, a type of skin cancer.
Merck launched Keytruda in 4Q14. Its global sales for 3Q15 were ~$159 million, a 45% increase compared to 2Q15. Keytruda is the number one therapy for melanoma in the US across all treatment classes. It holds over 70% of anti-PD1 patient share in the US markets. It is approved for first-line and second-line treatment of melanoma in the European Union.
Recent developments for Keytruda
Keytruda is undergoing one of the broadest clinical programs in oncology. It has clinical studies for over 30 different types of tumors. Some of the recent developments for Keytruda include:
The National Institute of Health and Care Excellence in the United Kingdom issued a draft recommendation for Keytruda as a first-line treatment option for adults with advanced melanoma. It also issued its final guidance recommending Keytruda for patients who have already undergone treatment with ipilimumab.
The FDA (the US Food and Drug Administration) approved Keytruda’s sBLA (supplemental biologics license application) for the treatment of previously treated patients with metastatic NSCLC (non-small cell lung cancer) whose tumors express PD-L1.
The Keynote-010 study showed superior overall survival compared to chemotherapy in patients with NSCLC whose tumors express PD-L1. Merck plans to provide regulatory submissions based on the data to the FDA by the end of 2015 and to the European Medicines Agency in early 2016.
The findings from the Keynote-028 study were presented at the European Cancer Congress. Keytruda is being investigated for the treatment of multiple tumor types.
Merck announced or initiated more than 25 registration studies for Keytruda in more than ten tumor types during the last quarter.
Overall, Keytruda’s clinical development program is studying more than 30 tumor types in more than 160 clinical trials. This includes over 80 combinations of Keytruda with other cancer treatments.
Other companies like AstraZeneca (AZN), AbbVie (ABBV), Bristol-Myers Squibb (BMY), and Pfizer (PFE) also compete with Merck on different products. Investors can consider ETFs like the S&P 500 SPDR ETF (SPY), which holds ~0.8% of its investment in Merck and Co., or the Health Care Select Sector SPDR ETF (XLV), which holds ~5.5% of its total investments in Merck, in order to divest company-specific risk.
Browse this series on Market Realist:
