Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit.
On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.
With the win, Merck will “discuss these results with regulatory authorities worldwide as soon as possible,” Marjorie Green, Merck’s head of oncology, global clinical development, said in a release.
Gaining approval for subcutaneous Keytruda would expand access for the world’s best-selling drug, which racked up sales of $25 billion last year. In its IV form, Keytruda is administered at infusion centers, with the procedure taking approximately 30 minutes, every three to six weeks.
During the trial, patients received Keytruda “in approximately 2-3 minutes,” Green added.
“Patients don’t want to be tethered. They can’t be tethered to an infusion center,” Dean Li, the head of Merck Research Laboratories, said last year at the J.P. Morgan Healthcare Conference. “If you can remove that for them, you will increase access not just in the cities, but in the world, throughout the United States, but in other countries. So this is [an] important innovation.”
During Merck’s third-quarter conference call last month, Li said that Keytruda was approved in 41 indications, with nine of those nods for the treatment of early-stage cancers. With Keytruda scheduled to lose its patent protection in the U.S. in 2028, the company is anxious to maximize its growth potential.
In the trial, subcutaneous Keytruda—which includes Alteogen’s berahyaluronidase alfa, an enzyme used to improve the absorption and dispersion of drugs and other agents—was given to metastatic non-small cell lung cancer patients along with chemotherapy. Another group of patients received IV Keytruda and chemotherapy.
Subcutaneous Keytruda administered with chemotherapy demonstrated its non-inferiority to IV Keytruda as evaluated in two pharmacokinetic measures—Area Under the Curve (AUC) exposure of Keytruda during the first dosing cycle, and trough concentration (Ctrough) of Keytruda measured at steady state.
In its hopes to clear a subcutaneous version of Keytruda, Merck is playing catch up with Roche, which gained approval of Tecentriq Hybreza in the U.K. in 2023 and was set to do the same in the U.S. before manufacturing delays pushed the nod back by 12 months.
In December, the FDA is scheduled to decide whether to approve Bristol Myers Squibb’s subcutaneous formulation of its PD-1 checkpoint inhibitor Opdivo.