Merck & Co. has announced positive results from a Phase 3 trial evaluating a subcutaneous formulation of pembrolizumab (Keytruda) in combination with chemotherapy. The trial demonstrated that the subcutaneous version was as effective as the original intravenous formulation. This development is particularly significant as Merck seeks to maintain its leadership in cancer care amid increasing competition and the impending patent expiration of Keytruda.
Keytruda's Market Dominance and the Need for Innovation
Keytruda has become a cornerstone of cancer treatment, holding 41 indications and generating $25 billion in sales in the past year. This success, however, makes Merck heavily reliant on Keytruda, which accounted for over 41% of the company's total sales in 2023. As direct competition looms in 2028, Merck is proactively bolstering its pipeline and innovating with new formulations like the subcutaneous version.
Subcutaneous Keytruda: A Competitive Edge
The subcutaneous Keytruda offers a significant advantage in administration time, requiring only 2-3 minutes for injection compared to the intravenous infusion, which can take up to an hour. This enhanced convenience could improve patient experience and potentially streamline treatment processes. Merck's subcutaneous delivery technology is developed in partnership with Alteogen, a South Korean company.
Marjorie Green, MD, Merck senior vice president and head of oncology global clinical development, noted the importance of this new formulation in maintaining Merck's competitive edge.
Competition in the Checkpoint Inhibitor Market
Merck faces increasing competition in the checkpoint inhibitor market. Roche's Genentech has already received FDA approval for a subcutaneous anti-PDL1 treatment, Tecentriq Hybreza, which utilizes Halozyme's delivery technology to reduce injection time to approximately seven minutes. In 2023, Tecentriq generated $4.2 billion in sales for Roche.
Bristol Myers Squibb is also developing a subcutaneous version of its anti-PD1 therapy, Opdivo, with an FDA decision expected soon. Opdivo's sales exceeded $9 billion last year, positioning it as a strong contender in the subcutaneous checkpoint inhibitor market.
Keytruda's Continued Growth and Expansion
Despite increasing competition, Keytruda continues to expand its market presence. In the third quarter of the past year, sales grew by 21% to $7.4 billion, driven by its wide range of indications, including non-small cell lung cancer. Merck is also exploring Keytruda's potential in earlier lines of cancer treatment, with nine FDA approvals for earlier-stage settings.
Gregory Lubiniecki, MD, VP of oncology research at Merck, has stated that Keytruda remains a strong choice as a control arm for other cancer trials because "it is such an important part of standard-of-care for many tumors."
