Keytruda, a Merck most cancers immunotherapy that has turn into the world’s top-selling treatment, is run as an intravenous infusion over the course of half-hour. The pharmaceutical large now has outcomes from a pivotal medical trial exhibiting an experimental injectable model of Keytruda dosed in minutes was roughly corresponding to the IV-administered drug. Merck now plans to debate these outcomes with regulators, laying the groundwork for potential submissions searching for approvals of the extra patient-friendly subcutaneous model.
Injectable Keytruda may enhance entry to the product with a model that’s much less burdensome to each sufferers and clinicians. For Merck, an injectable formulation would assist the corporate maintain on to some market share and income that will probably be misplaced when biosimilar variations of the drug turn into out there. In pursuing an injectable model of its blockbuster most cancers drug, Merck is taking the identical technique as another pharmaceutical firms that additionally face looming biosimilar competitors.
Pembrolizumab, model identify Keytruda, belongs to a category of immunotherapies referred to as checkpoint inhibitors. The drug is an antibody designed to dam PD-1, a protein on immune cells that hold these cells from recognizing and concentrating on tumors. Antibodies medicine are usually administered as IV infusions. Merck developed the injectable model of Keytruda with enzyme know-how that allows intravenous medicine to be administered as injections. This know-how, referred to as Hybrozyme, comes from South Korea-based Alteogen.
The outcomes introduced Tuesday are from an open-label Part 3 check enrolled about 378 adults with superior non-small cell lung most cancers. Keytruda was evaluated as a first-line therapy. Sufferers had been randomly assigned to obtain injectable Keytruda together with chemotherapy or IV-infused Keytruda and chemotherapy. Each drug regimens had been administered each six weeks. The principle objective was to evaluate pharmacokinetics (PK) — how the drug distributed within the physique.
With out releasing particular figures, Merck stated injectable Keytruda met the 2 important PK objectives of the examine, demonstrating publicity within the physique that was no worse than the IV-infused formulation of the drug throughout the first dosing cycle and on the Keytruda’s trough focus measured on the drug’s regular state. On secondary objectives of efficacy and security, Merck stated the subcutaneous formulation was according to the IV formulation. Merck stated these outcomes, plus information from ongoing analyses, will probably be introduced at an unspecified upcoming medical assembly and shared with regulatory authorities worldwide.
“It is rather encouraging to see constructive Part 3 outcomes evaluating this fixed-dose mixture of subcutaneous pembrolizumab, which was administered, on common, in roughly two to a few minutes and has the potential to enhance the affected person expertise in addition to improve entry for sufferers and healthcare suppliers in comparison with intravenous administration,” Marjorie Inexperienced, senior vice chairman and head of oncology, world medical improvement, Merck Analysis Laboratories, stated in a ready assertion.
Keytruda accounted for $21.6 billion in income by means of the primary three quarters of 2024, a 17.6% improve in comparison with the identical interval within the prior yr. It’s far and away Merck’s largest product by income and in addition the top-selling treatment on the earth. Keytruda drug faces patent expiration in 2028.
Merck isn’t the one firm that has turned to Alteogen’s know-how as a strategy to attempt to compete in opposition to biosimilars. Earlier this month, Daiichi Sankyo secured rights to make use of the know-how to develop a subcutaneous model of Enhertu, a blockbuster antibody drug conjugate most cancers remedy that’s commercialized in partnership with AstraZeneca. However Alteogen additionally has alliances with firms which are growing biosimilars. Sandoz has world rights to make use of the Alteogen know-how to develop a subcutaneous model of an unspecified biosimilar in its portfolio. That deal contains an choice for Sandoz to license the know-how for 2 extra merchandise.
Roche has already acquired FDA approvals for brand spanking new injectable formulations of two of its blockbuster merchandise. In September, the FDA permitted an injectable model of the pharma large’s most cancers immunotherapy Tecentriq. That approval was adopted by a regulatory nod for an injectable formulation of a number of sclerosis drug Ocrevus. Each Roche merchandise had been developed with Enhanze, a Halozyme drug supply know-how that allows biologic medicine to be administered as injections.
Photograph: Christopher Occhicone/Bloomberg through Getty Photographs
