Merck's Subcutaneous Keytruda Approval: A Game-Changer in Cancer Treatment

In a significant development for the pharmaceutical industry, Merck & Co. has secured FDA approval for Keytruda Qlex, a subcutaneous version of its blockbuster cancer drug Keytruda. This approval marks a pivotal moment in oncology treatment, offering potential benefits for patients, healthcare providers, and Merck's market position.

Keytruda Qlex: Enhancing Patient Convenience and Treatment Efficiency

Keytruda Qlex, the newly approved subcutaneous formulation, promises to dramatically reduce treatment time for cancer patients. While the intravenous Keytruda requires a 30-minute infusion, Keytruda Qlex can be administered in just one to two minutes, depending on the dosing schedule. This significant reduction in administration time could greatly improve patient experience and potentially increase treatment adherence.

Marjorie Green, Merck's head of oncology global clinical development, emphasized the value of this time-saving feature: "Just that time component and being able to give that back is really valuable for patients." The new formulation also offers flexibility in treatment settings, as it can be administered not only in infusion centers but also in doctors' offices and community clinics.

Efficacy and Approval Details

The FDA's approval of Keytruda Qlex covers 38 cancer indications, encompassing most of the solid tumor indications approved for the original intravenous formulation. This broad approval was based on the MK-3475A-D77 study, which demonstrated comparable efficacy between the subcutaneous and intravenous versions in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC).

Key findings from the study include:

• A 45% overall response rate in NSCLC patients treated with Keytruda Qlex, compared to 42% for the intravenous version
• Similar progression-free and overall survival rates between the two formulations
• Comparable blood concentrations and pharmacokinetic profiles

Strategic Implications for Merck

The approval of Keytruda Qlex comes at a crucial time for Merck, as the company faces the looming expiration of key Keytruda patents in 2028. This new formulation is part of Merck's strategy to maintain its market dominance in oncology and mitigate potential revenue losses from biosimilar competition.

Keytruda has been a cornerstone of Merck's financial success, with sales reaching $29.5 billion in 2024, accounting for more than half of the company's total revenue. Merck expects to transition 30% to 40% of Keytruda uses to the subcutaneous version within 18 months to two years, primarily in monotherapy settings or combinations with oral drugs.

However, Merck faces ongoing patent litigation with Halozyme Therapeutics regarding the human hyaluronidase protein used in Keytruda Qlex. This legal challenge adds a layer of complexity to the drug's market prospects.