Generic name: pembrolizumab
Company: Merck & Co.
2015 sales: $566 million
2022 sales: $6.56 billion
Current indications: advanced melanoma; non-small cell lung cancer; head and neck squamous cell cancer
Keytruda was the first PD-1/PD-L1 inhibitor to be approved for marketing in the U.S., ahead of Bristol-Myers Squibb's Opdivo, but has lagged behind its rival in sales pretty much from the get-go. That could change, given some trial results for the BMS med last fall—and that, in turn, could push Keytruda higher on this list by the time 2022 rolls around.
While Keytruda remains in direct competition with Opdivo in melanoma, second-line non-small cell lung cancer, and head and neck cancer, it got a chance to strike out on its own when it won an FDA approval to treat first-line NSCLC, while competitor Opdivo failed to meet its primary endpoint in that lucrative area.
Use of the drug is expected to ramp up quickly in previously untreated NSCLC patients whose tumors express high levels of PD-L1, a group which represents around 25% of the total population. That puts a greater emphasis on PD-L1 testing and in turn could boost use of the drug in patients who’ve failed on prior regimens.
Keytruda has been losing out to Opdivo in that second-line setting because its use depends on PD-L1 testing, while the BMS drug can be given to all comers. Roche's Tecentriq has now won a lung cancer approval for second-line use, too. But as Keytruda picks up momentum in first-line patients, that could transmit to its other indications—and to its 2022 sales. The current revenue forecast of around $6.5 billion that year would be far from shabby, but still just over half the projection for its archrival at the time this list was generated.
Like BMS, Merck is studying its drug for a host of other uses, including multiple myeloma, Hodgkin lymphoma, and breast cancer, as well as looking at the drug's role in combination therapies, which is where immuno-oncology drugs are really expected to shine.
For example, Merck has reported the results of a first-line NSCLC study showing a 70% response rate with Keytruda given in tandem with Eli Lilly's Alimta (pemetrexed) and platinum doublet therapy, something that R&D head Roger Perlmutter called "an amazing result," albeit in a small number of patients.