The FDA has granted approval for Merck & Co.’s subcutaneous formulation of Keytruda, known as Keytruda Qlex, enhancing patient convenience while protecting potential revenue from the world’s leading cancer drug. This move addresses the growing need for reducing treatment time, offering a significantly quicker administration method compared to the original intravenous version.
Keytruda Qlex retains the same solid tumor indications as the initial infusion-based Keytruda. With a staggering $8 billion in sales during the second quarter, Keytruda has become a cornerstone of Merck’s financial stability, contributing to more than half of the company’s overall revenue. However, with patent protection for the infused version set to expire in 2028, the new subcutaneous formulation is poised to strengthen Merck’s market position.
The convenience of Keytruda Qlex is one of its most significant advantages, allowing patients to receive the treatment via injection in roughly one minute every three weeks, or two minutes for every six-week regimen. In contrast, the traditional infusion requires more than half an hour. “Just that time component and being able to give that back is really valuable for patients,” said Marjorie Green, Merck’s head of oncology global clinical development.
This subcutaneous option not only alleviates the treatment burden on patients but also eases the demands on healthcare providers, thanks to its shorter preparation and administration times. The effectiveness of Keytruda Qlex was demonstrated in the MK-3475A-D77 study, which revealed that it offers similar pharmacokinetic properties to the intravenous version, with no notable differences in efficacy outcomes such as tumor response rates or overall survival among patients with metastatic non-small cell lung cancer (NSCLC).
While the recent trial focused on NSCLC, the FDA’s approval encompasses existing solid tumor indications for Keytruda. Merck is also conducting a pivotal study aimed at extending approval to blood cancer indications, targeting previously treated Hodgkin lymphoma and primary mediastinal large B cell lymphoma.
In the coming years, Merck anticipates transitioning 30% to 40% of its Keytruda usage to the subcutaneous formulation, particularly in settings where Keytruda is administered alone or alongside oral medications. The drug has increasingly been used in the treatment of various early-stage cancers, given as monotherapy following surgical tumor removal. Green highlighted the potential for Keytruda Qlex to be adopted in certain metastatic cancer scenarios, especially where chemotherapy infusions are limited to short durations.
Merck plans to incorporate the subcutaneous version into new clinical trials, including a combination with its oral KRAS inhibitor, MK-1084, in first-line NSCLC. Before Keytruda Qlex, Merck’s competitors had already rolled out subcutaneous versions of their own immunotherapies, such as Roche’s Tecentriq and Bristol Myers Squibb’s Opdivo.
From a competitive standpoint, Green expressed confidence that Keytruda Qlex can uphold the success of its predecessor, maintaining efficacy while offering the shortest administration time in the market. Merck is preparing to launch Keytruda Qlex, even as it navigates ongoing patent litigation with Halozyme Therapeutics concerning the human hyaluronidase protein essential for its subcutaneous delivery. This product uses Alteogen’s berahyaluronidase alfa, which Halozyme alleges infringes on its portfolio of modified hyaluronidase patents.
As Merck braces for key challenges, including the potentially impactful patent expiration of Keytruda and the underwhelming performance of its HPV vaccine, Gardasil, the company has initiated a cost-cutting plan aimed at saving $3 billion annually by 2027. This strategy includes a workforce reduction of approximately 6,000 jobs, representing 8% of Merck’s global staff, as it seeks to navigate the evolving landscape of the pharmaceutical industry.
