Subcutaneous Keytruda meets goals, says Merck

US pharma giant Merck & Co (NYSE: MRK) today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form.

The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck’s anti-PD-1 therapy, available for intravenous use as Keytruda, together with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen (MK-3475A; “subcutaneous pembrolizumab”), administered with chemotherapy versus intravenous (IV) Keytruda administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

Although Merck is not facing the loss of exclusivity on Keytruda until 2028, the data could help build up a patchwork of indications and trials to stave off a full switchover to biosimilar versions of the drug, according to BMO Capital Markets analysts. Keytruda generated sales of $25 billion last year.