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Clinical Trial
. 2025 Dec;42(12):6175-6189.
doi: 10.1007/s12325-025-03365-7. Epub 2025 Oct 21.

A Time and Motion Study Comparing Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab in Combination with Chemotherapy for the Treatment of Metastatic Non-small Cell Lung Cancer

Erwin De Cock  1 , Sabine Oskar  2 , Cecilia Lourdudoss  3 , Renata Eiras  2 , M Catherine Pietanza  2 , Ashwini Arunachalam  2 , Gustavo Alves  4 , Gaston Lucas Martinengo  5 , Enriqueta Felip  6
Affiliations
Clinical Trial

A Time and Motion Study Comparing Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab in Combination with Chemotherapy for the Treatment of Metastatic Non-small Cell Lung Cancer

Erwin De Cock et al. Adv Ther. 2025 Dec.

Abstract

Introduction: Subcutaneous (SC) formulations of oncology therapies could provide time-saving benefits for both patients and healthcare professionals (HCPs) compared with intravenous (IV) delivery. This prospective observational study, conducted alongside the MK-3475A-D77 phase 3, open-label randomized clinical trial, quantifies HCP and patient time with pembrolizumab SC versus pembrolizumab IV among patients with metastatic non-small cell lung cancer.

Methods: Seventeen sites across eight countries in Europe (n = 4), South America (n = 3), and Asia (n = 1) were enrolled. Primary endpoints were active HCP time; patient time in the treatment chair, treatment room, and healthcare facility; and consumables usage. Descriptive statistics included weighted mean (WM), and a linear mixed model (LMM) was employed to explore differences in time measures between pembrolizumab SC and pembrolizumab IV per visit.

Results: Overall, 212 observations were analyzed (153 SC and 59 IV). Total active HCP time was reduced by 45.6% with SC versus IV (WM, 14.0 vs 25.8 min); HCPs spent 44.3% less time on the drug preparation process with SC versus IV (WM, 5.1 vs 9.1 min) and 46.3% less time on the drug administration process with SC versus IV (WM, 8.9 vs 16.7 min). Patient chair time was reduced by 49.6% with SC versus IV (WM, 59.0 vs 117.2 min). Patients receiving SC spent less time in the treatment room than those receiving IV (WM, 66.7 vs 126.9 min; difference - 47.4%). Exploratory LMM showed considerable between-group differences for active HCP time and patient time in the treatment chair and treatment room.

Conclusion: Pembrolizumab SC substantially reduces active HCP time and patient chair time versus pembrolizumab IV. Time liberated for HCPs could be reallocated toward additional patient care activities, while optimized chair utilization could improve overall healthcare efficiency.

Keywords: Clinic workflow; Healthcare professional time; Non-small cell lung cancer; Operational efficiency; Patient chair time; Pembrolizumab; Subcutaneous administration; Time and motion study; Time savings; Treatment efficiency.

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Conflict of interest statement

Declarations. Conflict of Interest: Erwin De Cock was an employee of Syneos Health at the time of the study. Since the time of the study, Erwin De Cock is no longer affiliated with Syneos Health. Cecilia Lourdudoss is an employee of Syneos Health. Sabine Oskar, Renata Eiras, M. Catherine Pietanza, and Ashwani Arunachalam are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD), who may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. Gustavo Alves received research support from MSD, grants or contracts from Roche, AstraZeneca, Bristol Myers Squibb, MSD, Merck Serono, Pfizer, BeiGene, Ipsen; consulting fees from AstraZeneca and MSD; payment or honoraria from GlaxoSmithKline, AstraZeneca, MSD; and travel support from Janssen Pharmaceuticals. Gaston Lucas Martinengo reported no conflicts of interest. Enriqueta Felip reported receiving consulting fees from AbbVie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daichii, F. Hoffmann–La Roche, Gilead, GlaxoSmithKline, Iteos Therapeutics, Janssen Pharmaceuticals, Johnson & Johnson, MSD, Novartis, Pierre Fabre, Pfizer, Regeneron, Turning Point; payment or honoraria from Amgen, AstraZeneca, Bristol Myers Squibb, Daichii Sankyo, Eli Lilly, F. Hoffmann–La Roche, Genentech, Gilead, Janssen Pharmaceuticals, Johnson & Johnson, Medical Trends, Medscape, Merck Serono, MSD, Novartis, Peervoice, Pfizer, Regeneron; travel support from AstraZeneca, Janssen Pharmaceuticals, and Roche; and served as an independent member of the board for Grifols Diagnostic Solutions Inc. Ethical Approval: Ethics approval for this T&M study was obtained for each site in accordance with local regulations, where applicable. The study was conducted in compliance with the approved protocol, the applicable principles outlined in Good Pharmacoepidemiology Practice guidelines, and the Declaration of Helsinki (1964 and its later amendments). The WCG IRB served as the master ethics committee for this study. WCG IRB approval was received on 13 Sep 2023 (WCG IRB tracking number: 20234046). Additional IRBs overseeing site-specific approvals are listed in Supplementary Material Table S1, along with their respective reference identifiers. All HCPs provided written agreements prior to observation. Patients under passive observation verbally consented after reviewing the study’s patient information leaflet. All HCPs and study sites participated voluntarily and retained the right to withdraw from the study at any time and for any reason.

Figures

Fig. 1
Fig. 1
Patient pathway during clinic visit and HCP pathway showing generic workflows for pembrolizumab IV and pembrolizumab SC preparation and administration processes. Workflow variations may have occurred between study sites and were captured by site-specific case report forms. Boxes do not represent duration of time. HCP healthcare professional, IV intravenous, pembro pembrolizumab, SC subcutaneous
Fig. 2
Fig. 2
Overall average active HCP time for preparation and administration processes by treatment group. Values are in weighted mean time (minutes). HCP healthcare professional, IV intravenous, pembro pembrolizumab, SC subcutaneous
Fig. 3
Fig. 3
Overall average patient time spent in the treatment chair, treatment room, and healthcare facility, by treatment groupa. Values are in weighted mean time (minutes). aFor observations including concomitant chemotherapy [43/59 (72.9%) for pembrolizumab IV and 85/153 (55.6%) for pembrolizumab SC; 98% pemetrexed for both treatment groups], any time associated with chemotherapy administration (on average 12.7 min) was removed from patient time endpoints (see Statistical analysis). IV intravenous, pembro pembrolizumab, SC subcutaneous
Fig. 4
Fig. 4
Consumables usage for pembrolizumab SC and pembrolizumab IV. Values are weighted mean units. IV, intravenous; pembro, pembrolizumab; SC, subcutaneous
See this image and copyright information in PMC

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