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The US FDA has approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck), a subcutaneous version of the intravenous formulation of Keytruda, for adults and children aged 12 years or older.
The new approval is for all solid tumor indications approved for the intravenous formulation. Prescribing information, including indications, can be found at Drugs@FDA. Recommended dosing for the subcutaneous formulation is either 395 mg pembrolizumab and 4800 units of berahyaluronidase alfa-pmph every 3 weeks or 790 mg and 9600 units of the agents, respectively, every 6 weeks until disease progression or unacceptable toxicity or as indicated in the prescribing information.
Efficacy and safety of Keytruda Qlex was evaluated in the randomized, open-label MK-3475A-D77 trial of 377 treatment-naive patients with metastatic non-small cell lung cancer with no EGFR, ALK, or ROS1 mutations. No significant differences were observed in pharmacokinetic (PK) endpoints or response rates between those randomly assigned to receive the subcutaneous formulation and those who received the intravenous formulation.
PK endpoints were cycle 1 AUC0-6 weeks and cycle 3 Ctrough. The trial met the predefined acceptance margin for the PK endpoints with the lower boundary of the geometric mean ratios above the prespecified threshold of 0.8 for comparability.
Overall response rates were 45% and 42% with subcutaneous and intravenous treatment, respectively, and no notable differences were observed in progression-free and overall survival.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X @SW MedReporter.
