KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
September 19, 2025--RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. KEYTRUDA QLEX must be administered by a health care provider (HCP). Merck expects to have KEYTRUDA QLEX (pronounced key-TRUE-duh Q-lex) available in the U.S. in late September. For a full list of the 38 indications for which KEYTRUDA QLEX is approved, see “KEYTRUDA QLEX Indications” below.
“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 administered every six weeks, each with chemotherapy, was conducted in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations. This trial demonstrated comparable pharmacokinetic exposure levels to pembrolizumab [assessed as Cycle 1 AUC0-6 weeks (area under the curve from 0 to 6 weeks) and Cycle 3 (i.e. Steady State) Ctrough]. In descriptive efficacy analyses, overall response rates (ORR) were similar between KEYTRUDA QLEX and KEYTRUDA (45% [95% CI: 39, 52] vs 42% [95% CI: 33, 51]). Additionally, no notable differences were observed in progression-free survival (PFS) and overall survival (OS). Effectiveness of KEYTRUDA QLEX for its approved indications was established based on these data and pivotal trial data demonstrating comparable safety with KEYTRUDA, as well as evidence from adequate and well-controlled studies conducted with KEYTRUDA.
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. Additionally, immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD-L1 blocking antibody, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection and other transplant (including corneal graft) rejection. Additionally, fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment. Consider the benefit versus risks for these patients. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled trials due to the potential for increased mortality. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA QLEX. Based on the severity of the adverse reaction, KEYTRUDA QLEX should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA QLEX can also cause severe or life-threatening administration-related reactions. Based on its mechanism of action, KEYTRUDA QLEX can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.
As a subcutaneous injection, KEYTRUDA QLEX may provide added convenience compared to IV KEYTRUDA because it can be administered by HCPs in multiple settings from an infusion center to a doctor’s office or a local community-based clinic, providing more options where patients can receive their treatment. KEYTRUDA QLEX also provides flexibility in treatment administration. It can be given in one minute every three weeks or in two minutes every six weeks, requiring substantially less time to administer than a 30-minute IV infusion of KEYTRUDA, and also offers a choice of injection site in the thigh or abdomen avoiding the 5 cm area around the navel. For patients who do not require a port or whose veins are difficult to access, subcutaneous administration may simplify treatment administration.
“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.
Study 3475A-D77 trial design and additional data supporting the approval
Study 3475A-D77 is a multicenter, randomized, open-label, active-controlled Phase 3 trial (ClinicalTrials.gov, NCT05722015) conducted in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations. The primary outcome measure was pembrolizumab exposure [Cycle 1 AUC0-6 weeks and Cycle 3 (i.e. Steady State) Ctrough] of subcutaneous KEYTRUDA QLEX as compared to IV pembrolizumab. Additional descriptive efficacy outcome measures were ORR by blinded independent central review (BICR), PFS by BICR and OS.
A total of 377 patients were randomized 2:1 to receive either KEYTRUDA QLEX (790 mg/9,600 units) every six weeks with platinum doublet chemotherapy (n=251) or pembrolizumab (400 mg) every six weeks with platinum doublet chemotherapy (n=126).
At the primary analysis, the confirmed ORR was 45% (95% Cl: 39, 52) in the subcutaneous KEYTRUDA QLEX arm versus 42% (95% Cl: 33, 51) for IV pembrolizumab arm. There were no notable differences in PFS and OS observed in patients who received KEYTRUDA QLEX compared to patients who received IV pembrolizumab.
The most common adverse reactions (≥20%) of patients who received KEYTRUDA QLEX in combination with chemotherapy were nausea (25%), fatigue (25%), and musculoskeletal pain (21%).
About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use
KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL).
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.