Evidence map›Paper›PMID 40272712›Full record

SynthesisAdvances in therapy2025

Pembrolizumab with Carboplatin and Paclitaxel Versus Alternative Systemic Treatments Recommended for the First-Line Treatment of Recurrent/Metastatic Head and Neck Cancer: An Indirect Treatment Comparison.

Marcin Dzienis, Ali Mojebi, Sam Keeping, Christopher M Black, Hilde Giezek, Niroshini Naicker, Chiara Vanetta, Julie E Park, Keith Chan, Sanjay Merchant and 1 more

2 registry-linked trialsAbstract readComparative StudyNetwork Meta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT02358031 phase3completednot on this map

A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2023Enrolled882ConditionsRecurrent Head and Neck Cancer, Metastatic Head and Neck CancerArmsPembrolizumab, Cisplatin, Carboplatin, 5-FU, Cetuximab
NCT04489888 phase4completednot on this map

A Phase 4, Single-arm, Open-label Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Efficacy and Safety of MK-3475 Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE B10).

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2020 to 2024Enrolled101ConditionsSquamous Cell Carcinoma of Head and NeckArmsPembrolizumab, Carboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Marcin DzienisCancer Department, Gold Coast University Hospital, Southport, QLD, Australia.ORCID http://orcid.org/0000-0002-8475-3282
Ali MojebiEvidence Synthesis, Precision AQ, Vancouver, BC, Canada.ORCID http://orcid.org/0000-0003-2318-8627
Sam KeepingEvidence Synthesis, Precision AQ, Vancouver, BC, Canada.ORCID http://orcid.org/0000-0002-4281-1536
Christopher M BlackValue and Implementation, Outcomes Research, Merck & Co., Inc., Rahway, NJ, USA.ORCID http://orcid.org/0000-0003-2934-108X
Hilde GiezekBiostatistics and Research Decision Sciences, Health Technology Assessment, MSD, Brussels, Belgium.
Niroshini NaickerOncology European Clinical Development, MSD (UK) Limited, London, UK.
Chiara VanettaBiostatistics and Research Decision Sciences, Health Technology Assessment, MSD, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-3741-6208
Julie E ParkEvidence Synthesis, Precision AQ, Vancouver, BC, Canada.ORCID http://orcid.org/0000-0002-8054-5443
Keith ChanEvidence Synthesis, Precision AQ, Vancouver, BC, Canada.
Sanjay MerchantValue and Implementation, Outcomes Research, Merck & Co., Inc., Rahway, NJ, USA.
Dandan ZhengValue and Implementation, Outcomes Research, Merck & Co., Inc., Rahway, NJ, USA. dandan.zheng@merck.com.ORCID http://orcid.org/0000-0002-6460-4036

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBased on the results of KEYNOTE-048 (NCT02358031), first-line standard-of-care treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) includes pembrolizumab alone or with platinum and fluorouracil (5-FU). Results from the single-arm KEYNOTE-B10 (NCT04489888) showed promising antitumor activity and a manageable safety profile offering an alternative pembrolizumab and chemotherapy regimen (KN-B10), with paclitaxel replacing 5-FU. With KEYNOTE-B10 being a non-comparative trial, this study aims to estimate the comparative efficacy of KN-B10 versus alternative first-line systemic treatments for R/M HNSCC via an indirect treatment comparison analysis.

methodsA systematic literature review (October 2023) identified six connected randomized controlled trials with similar eligibility criteria to KEYNOTE-B10. Interventions included cetuximab + platinum + 5-FU (EXTREME), cetuximab + cisplatin + docetaxel (TPEx), pembrolizumab + platinum + 5-FU (KN-048), platinum + 5-FU, cisplatin + paclitaxel, cisplatin, 5-FU, and methotrexate. To connect KEYNOTE-B10 to the network, individual patient-level data were weighted to match the population characteristics of the most similar trial in the network (KEYNOTE-048). The comparative efficacy of KN-B10 versus other interventions was estimated via fixed-effect Bayesian network meta-analyses. Due to violations of the proportional-hazards assumption, fractional polynomials were used to model overall survival (OS) and progression-free survival (PFS).

resultsFor objective response, KN-B10 was comparable to EXTREME and TPEx and more efficacious than all other identified treatments (range of odds ratios [ORs]: 1.69-11.75), including KN-048 (OR: 1.69; 95% credible interval: 1.01-2.81). For OS and PFS, KN-B10 was comparable to EXTREME (with improvements in OS after month 12), TPEx, and KN-048. KN-B10 improved OS versus platinum + 5-FU (range of time-varying hazard ratios: 0.60-0.18; months 9-60), cisplatin + paclitaxel (0.53-0.24; 9-36), cisplatin (0.59-0.32; 6-24), 5-FU (0.58-0.20; 6-36), and methotrexate (0.61-0.07; 6-60). KN-B10 improved PFS versus platinum + 5-FU (0.60-0.31; 3-36).

conclusionThe improved or comparable efficacy of KN-B10 versus alternative first-line interventions in terms of relevant clinical outcomes, as shown in this study, supports its recommendations for the treatment of R/M HNSCC.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHead and Neck NeoplasmsNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckCarboplatinFluorouracilHumansPaclitaxelRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedCarboplatinFluorouracilPaclitaxelpembrolizumabCarboplatinFirst-lineHead and neck squamous cell carcinomaImmuno-oncologyKEYNOTE-B10Matching-adjusted indirect comparisonNetwork meta-analysisPaclitaxelPembrolizumab

Identifiers

PMID40272712

What OpenQuestion holds

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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.