What Happened with Merck’s Keytruda in 2017?

In 4Q17, Merck’s (MRK) Keytruda generated revenues of $1.3 billion, compared with $483 million in 4Q16. In 4Q17, Keytruda witnessed a ~24% rise on a QoQ (quarter-over-quarter) basis. In 4Q17, in the US and in international markets, Keytruda reported revenues of $783 million and $510 million, respectively, compared with $311 million and $172 million in 4Q16.

In fiscal 2017, Keytruda reported revenues of $3.8 billion, compared with $1.4 billion in 2016, which reflected a ~172% rise on a YoY (year-over-year) basis. In 2017, in the US and in international markets, Keytruda reported revenues of $2.3 billion and $1.5 billion, respectively, compared with $792 million and $610 million in 2016.

In January 2018, Merck announced that its pivotal phase-3 Keynote-189 trial met its primary endpoints of overall survival and progression-free survival. Merck conducted the phase-3 Keynote-189 trial to evaluate the safety and efficacy of Keytruda in combination with Eli Lilly’s (LLY) Alimta and cisplatin or carboplatin for the first-line treatment of individuals with metastatic non-squamous non-small cell lung cancer.

The success of the clinical trial should help Merck file regulatory filing for the label expansion of the drug and further strengthen Keytruda’s commercialization capabilities.

In January 2018, Merck presented the data from the registrational phase-2 Keynote-224 trial, which is being conducted to evaluate Keytruda for the treatment of individuals with advanced hepatocellular carcinoma, or HCC. In the Keynote-224 trial, Keytruda monotherapy demonstrated an ORR (overall response rate) of 16.3% in individuals with advanced HCC.

In the marketplace, Keytruda’s peers include Roche’s (RHHBY) Avastin, Bristol-Myers Squibb’s (BMY) Opdivo, Eli Lilly’s (LLY) Alimta and Cyramza, and AstraZeneca’s (AZN) Imfinzi.