Merck , known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous injection in adults across most KEYTRUDA® (pembrolizumab) solid tumor indications. Berahyaluronidase alfa, a variant of human hyaluronidase, is developed and manufactured by Alteogen Inc. KEYTRUDA QLEX must be administered by a healthcare provider (HCP), with availability expected in the U.S. in late September. For a full list of the 38 approved indications, see “KEYTRUDA QLEX Indications.”
“This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers. We now have a new option with a broad set of indications that has demonstrated comparability with intravenous (IV) pembrolizumab but in a subcutaneous injection that can be administered in one minute every three weeks or two minutes every six weeks,” said Dr. J. Thaddeus Beck, oncologist and Medical Director of the Highlands’ Clinical Trials Office. “Subcutaneous pembrolizumab provides faster administration than IV pembrolizumab, offers two dosing options and gives patients more choices of health care settings in which they can receive their therapy.”
The pivotal trial comparing subcutaneous KEYTRUDA QLEX to IV KEYTRUDA every six weeks, both with chemotherapy, included treatment-naïve metastatic non-small cell lung cancer (NSCLC) patients without EGFR, ALK, or ROS1 genomic tumor aberrations. The study demonstrated comparable pharmacokinetic exposure to pembrolizumab, with similar overall response rates (45% vs 42%) and no notable differences in progression-free survival or overall survival. Safety profiles were also comparable.
KEYTRUDA QLEX is contraindicated in patients with hypersensitivity to berahyaluronidase alfa, hyaluronidase, or any excipients. Severe immune-mediated reactions can occur in multiple organ systems, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, and transplant rejection. Fatal complications may occur in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT). Early recognition and management of immune-mediated reactions are essential, with treatment withheld or discontinued as necessary. Administration-related reactions and potential fetal harm in pregnant women are also key considerations.
Subcutaneous administration offers convenience, enabling HCPs to deliver treatment in multiple settings, from infusion centers to community clinics. KEYTRUDA QLEX can be administered in one minute every three weeks or two minutes every six weeks, substantially reducing time compared to a 30-minute IV infusion. Injection sites can be the thigh or abdomen, avoiding a 5 cm area around the navel, simplifying treatment for patients without a port or with difficult veins.
“At Merck, we are committed to putting patients first, as we work relentlessly to discover new options that may help patients manage their treatment in a way that fits their needs,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are honored to build on the foundation of KEYTRUDA with KEYTRUDA QLEX, a new injectable immunotherapy option that has similar results to KEYTRUDA and can be administered in as little as one minute.”
“As part of supporting patients and families through their cancer journeys, we are excited to see patient-focused developments in subcutaneous cancer treatment that shorten administration time and may allow for more patients to receive treatment in multiple health care settings,” said Sally Werner, Chief Executive Officer, Cancer Support Community.