Evidence map›Paper›PMID 40157574›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2025

Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial.

E Felip, C I Rojas, M Schenker, D M Kowalski, I A Casarini, T Csöszi, M A N Şendur, J Martins, A Calles Blanco, C-C Wang and 9 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05722015 (A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05722015 phase3active not recruitingnot on this map

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2023 to 2028Enrolled377ConditionsMetastatic Non-small Cell Lung CancerArmsPembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Review
  5. Pharmacokinetic insights into atezolizumab SC: viability of extended dosing intervals beyond the standard regimen.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Subcutaneous immunotherapy as a catalyst for decentralized, oncologist-led cancer care: a mixed-methods analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  12. Review
  13. Article
  14. Strategies to target PD-1/PD-L1 in the tumor microenvironment.Cellular oncology (Dordrecht, Netherlands) · 2026
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

E FelipVall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Universitat Autonoma de Barcelona, Barcelona, Spain. Electronic address: efelip@vhio.net.
C I RojasBradfordhill-Clinical Area, Santiago, Chile.
M SchenkerMedical Oncology, Sfântul Nectarie Oncology Center, Craiova, Romania.
D M KowalskiDepartment of Lung Cancer and Thoracic Tumours, Marie Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
I A CasariniHospital Houssay, Mar del Plata, Buenos Aires, Argentina.
T CsösziHetényi Géza Hospital, Oncology Center of Jász-Nagykun-Szolnok County, Szolnok, Hungary.
M A N ŞendurAnkara Yıldırım Beyazıt University and Ankara Bilkent City Hospital, Ankara, Turkey.
J MartinsJoinville Institute of Hematology and Oncology, Joinville, Brazil.
A Calles BlancoGregorio Marañon University General Hospital, Madrid, Spain.
C-C WangChang Gung Memorial Hospital at Kaohsiung, Kaohsiung, Taiwan.
M WangBeijing Peking Union Medical College Hospital, Beijing, China.
R A L Ramirez FallasPrivate Practice, Guatemala City, Guatemala.
H YoshiokaKansai Medical University Hospital, Osaka, Japan.
S NairMid Florida Hematology and Oncology Center, Orange City, USA.
X SongShanxi Cancer Hospital, Shanxi, China.
X DengMerck & Co., Inc., Rahway, USA.
M LalaMerck & Co., Inc., Rahway, USA.
R EirasMerck & Co., Inc., Rahway, USA.
T TakahashiShizuoka Cancer Center, Shizuoka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPembrolizumab with berahyaluronidase alfa is for subcutaneous (s.c.) administration. The phase III open-label 3475A-D77 study (NCT05722015) assessed s.c. pembrolizumab versus intravenous (i.v.) pembrolizumab, plus chemotherapy, for treatment of metastatic non-small-cell lung cancer (mNSCLC). PATIENTS AND

methodsParticipants with newly diagnosed stage IV squamous or nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations were randomized 2 : 1 to pembrolizumab s.c. 790 mg every 6 weeks (q6w) or pembrolizumab i.v. 400 mg q6w (18 cycles), each given with platinum-doublet chemotherapy. Dual primary endpoints were pharmacokinetic exposure measures of cycle 1 area under the curve (AUC

resultsIn total 377 participants were randomized to the pembrolizumab s.c. (n = 251) or i.v. (n = 126) arms. The median time from randomization to data cut-off (12 July 2024) was 9.6 months (range 6.2-16.4 months). The median injection time for pembrolizumab s.c. was 2.0 min (range 1-12 min). The GMR [96% confidence interval (CI)] for cycle 1 AUC

conclusionsOverall exposure and trough concentrations of pembrolizumab s.c. 790 mg q6w were noninferior to those of pembrolizumab i.v. 400 mg q6w given with chemotherapy in participants with treatment-naive mNSCLC. Results support pembrolizumab s.c. as a treatment option in all indications where pembrolizumab i.v. can be used.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsAdministration, IntravenousAdultAgedFemaleHumansInjections, SubcutaneousMaleMiddle AgedAntibodies, Monoclonal, Humanizedpembrolizumabimmunotherapynon-small-cell lung cancerpembrolizumabphase IIIprogrammed cell death protein 1subcutaneous

Identifiers

PMID40157574

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.