Subcutaneous Pembrolizumab Is FDA Approved, Slashes Chair Time

Subcutaneous pembrolizumab cut chair time and prep time each by nearly half.

The FDA has approved the use of pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), the subcutaneous formulation of pembrolizumab (Keytruda) for all previously approved indications of the latter, according to an announcement from the agency.¹

According to a news release from Merck, subcutaneous pembrolizumab cut chair time by 49.7% and time in the treatment room by 47.4%.² Time spent on treatment preparation, administration process, and patient monitoring was also cut by 45.7%.

The approval will affect all indications of pembrolizumab, spanning breast, lung, hematologic, gastrointestinal, gynecologic, genitourinary, and more cancer types.¹

Unpacking Efficacy Data

The efficacy of subcutaneous pembrolizumab was determined in the randomized, multicenter, open-label, and active-controlled Study MK-3475A-D77 (NCT05722015). The study investigated the use of this formulation in 377 patients with treatment-naive metastatic non-small cell lung cancer (NSCLC) harboring no EGFR, ALK, or ROS1 mutations.

Patients were randomized 2:1 to receive either treatment with subcutaneous pembrolizumab or standard intravenous pembrolizumab, respectively. All patients received platinum doublet chemotherapy.

The objective response rate in the subcutaneous arm was 45% (95% CI, 39%-52%) vs 42% (95% CI, 33%-51%). No noteworthy differences were observed in PFS or OS.

According to data published in ESMO Annals of Oncology, the median duration of response (DOR) was 9.1 months (range, 6.9 months-not reached [NR]) in the subcutaneous arm and 8.0 months (range, 7.4 months-NR) in the intravenous arm.³

Dual pharmacokinetic primary end points included Cycle 1 area under the curve and steady-state trough concentration of pembrolizumab. Secondary end points included safety, efficacy, pembrolizumab immunogenicity, and additional pharmacokinetic exposure measures.

Descriptive efficacy outcomes included ORR by blinded independent central review (BICR), progression-free survival by BICR, and overall survival (OS).

What Should Nurses Know About Subcutaneous Pembrolizumab?

The median injection time was 2.0 minutes (range, 1-12 minutes). According to Merck’s news release, the weighted mean (WM) chair times for patients receiving subcutaneous and intravenous pembrolizumab were 59.0 minutes and 117.2 minutes, respectively (P < .0001).² Likewise, WM time in the treatment room was 66.7 minutes vs 126.9 minutes, respectively.

WM total active health care professionals (HCPs) time was 14.0 minutes in the subcutaneous arm compared with 25.8 minutes in the intravenous arm. HCPs spent 44.6% less time on preparation of subcutaneous pembrolizumab vs intravenous (5.1 minutes vs 9.2 minutes) and 46.7% less time on administration process and patient monitoring (8.9 minutes vs 16.7 minutes).

Treatment-related adverse events (TRAEs) led to treatment discontinuation in 8.4% of patients receiving subcutaneous pembrolizumab and 8.7% of patients receiving intravenous pembrolizumab.³ Global health status/quality of life (QOL), physical functioning, and role functioning, assessed with the EORTC QLQ-C30, as well as overall health and QOL as measured by the EQ-5D-5L visual analogue scale score were not significantly different across treatment arms.

Regarding the safety of subcutaneous, results demonstrated consistency between pembrolizumab’s established safety profile and the observed safety of subcutaneous pembrolizumab.

Pembrolizumab’s label contains warnings for immune-mediated adverse reactions, hypersensitivity and administration-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.

What Dose is Recommended for Subcutaneous Pembrolizumab?

Subcutaneous pembrolizumab is recommended at a dose of either 395 mg of pembrolizumab and 4800 units of berahyaluronidase alfa-pmph every 3 weeks or 790 mg of pembrolizumab and 9600 units of berahyaluronidase alfa-pmph every 6 weeks.

References

1. FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection. FDA. September 19, 2025. Accessed September 19, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection
2. Merck’s investigational subcutaneous pembrolizumab with berahyaluronidase alfa demonstrates noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in pivotal 3475A-D77 trial. News release. Merck & Co., Inc. March 27, 2025. Accessed September 19, 2025. https://www.businesswire.com/news/home/20250327895076/en/Mercks-Investigational-Subcutaneous-Pembrolizumab-With-Berahyaluronidase-Alfa-Demonstrates-Noninferior-Pharmacokinetics-Compared-to-Intravenous-IV-KEYTRUDA-pembrolizumab-in-Pivotal-3475A-D77-Trial
3. Felip E, Rojas CI, Schenker M, et al. Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial. Ann Oncol. 2025;36(7):775-785. doi:10.1016/j.annonc.2025.03.012