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Merck (NYSE:MRK) is ramping up its R&D efforts to introduce a new version of the blockbuster cancer drug Keytruda, as the pharma giant faces loss of market exclusivity for its top revenue generator later this decade.
The intravenously delivered anti-PD-1 therapy is approved for nearly 40 indications in the U.S., and it accounted for more than 40% of the company’s total sales in 2023, adding $25.0B to the top line.
As its U.S. patent cliff in 2028 nears, the company is accelerating its efforts to introduce a subcutaneous version of the drug, also known as pembrolizumab.
Rahway, New Jersey-based MRK is recruiting patients for at least two clinical trials designed to study subcutaneous Keytruda against its intravenous version.
According to an update posted in a federal register this week, the company has increased the number of study sites for a Phase 2 trial designed to test subcutaneous Keytruda in multiple tumors. That trial, targeted at more than 100 patients, is expected to be completed in 2026.
A recruitment drive is also underway for a Phase 3 trial designed to test subcutaneous pembrolizumab versus intravenous Keytruda plus chemotherapy as a first-line option for adults with lung cancer.
A recent update shows that its enrollment has improved to more than 370 patients last month. The Japan-based trial is expected to be completed in 2028.
The new formulation “is an innovation that is going to be demanded and is being demanded by the field,” Merck (MRK) research chief Dean Li said during the company’s recent earnings call.
Generic drugmakers are taking notice. In late February, Korean biopharma Samsung Bioepis announced the start of a Phase 1 trial for its Keytruda biosimilar, SB27. The trial, targeted at 135 patients with lung cancer, is expected to be completed in 2025.
Other drugmakers eyeing Keytruda biosimilars include Novartis (NVS) spinoff Sandoz (OTCQX:SDZNY). Its copycat version, GME751, is set for Phase 3 and Phase 1 trials in lung and skin cancer, expected to be completed in 2026 and 2025, respectively.