Evidence map›Paper›PMID 40053697›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

Pembrolizumab in Combination with Binimetinib in Patients with Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer.

Saranya Chumsri, Joseph J Larson, Emily Liu, Kathleen S Tenner, Daniel Adams, Morgan T Weidner, Amanda N Arnold, Dana L Haley, Pooja Advani, Kostandinos Sideras and 4 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

14 authors.

Saranya ChumsriDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0001-7117-1446
Joseph J LarsonDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0001-8372-0465
Emily LiuDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.ORCID 0009-0007-1020-1227
Kathleen S TennerDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0003-4607-4286
Daniel AdamsCreatv MicroTech Inc., Rockville, Maryland.ORCID 0000-0002-1916-9637
Morgan T WeidnerDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0009-0003-0550-6940
Amanda N ArnoldDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0009-0007-1555-1314
Dana L HaleyDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0009-0000-7800-2370
Pooja AdvaniDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0009-0007-5470-3149
Kostandinos SiderasDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0002-4698-2105
Alvaro Moreno-AspitiaDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0002-2317-2580
E Aubrey ThompsonDepartment of Cancer Biology, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0002-9001-4240
Edith A PerezDivision of Hematology-Oncology, Department of Medicine, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0002-5037-6677
Keith L KnutsonDepartment of Cancer Biology, Mayo Clinic, Jacksonville, Florida.ORCID 0000-0001-9932-4467

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
The Role of CHFR in Tumorigenesis and Paclitaxel-Sensitivity in Breast CancerP50CA116201 · NCI · MAYO CLINIC ROCHESTER · PI Fergus Joseph Couch · 2005 to 2026
$49.9M
Bankhead-Coley Foundation 22BC08Breast Cancer Research Foundation (BCRF) BCRF 23-161NCI NIH HHS P30 CA015083NCI NIH HHS P50 CA116201
6 · The paper itself

Abstract

purposeActivation of the RAS/MAPK pathway is associated with reduced tumor-infiltrating lymphocytes and poor outcomes in triple-negative breast cancer. Previous studies demonstrated that inhibition of the MAPK pathway with a MEK inhibitor is synergistic with immune checkpoint inhibitors. PATIENTS AND

methodsWe conducted a phase I/II trial of pembrolizumab and binimetinib in patients with metastatic triple-negative breast cancer with ≤3 prior lines of therapy. There were two dose levels (DL) with binimetinib at 45 mg at DL 0 and 30 mg at DL -1.

resultsThe recommended phase II dose was the standard dose of pembrolizumab with binimetinib 30 mg twice daily. The objective response rate (ORR) was 30.4%, with a numerically higher ORR in patients without liver metastasis at 45.5%. Among patients who achieved objective responses, 80% had a duration of response >12 months and ongoing even after stopping treatment (5.4-69.0 months). Patients with PD-L1-positive tumors (modified proportion score ≥10) were more likely to respond with an ORR of 66.7%. However, clinical benefit was observed in 25% of patients with PD-L1-negative tumors. Consistent with preclinical studies, four of six patients with clinical benefit had either increased PD-L1 or decreased p-ERK expressions in serial circulating cancer-associated macrophage-like cells after starting binimetinib.

conclusionsPembrolizumab and binimetinib at 30 mg are safe with manageable toxicities. Promising activity was observed in patients without liver metastases. Future larger clinical trials are warranted to further evaluate the efficacy of this chemotherapy-free combination.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesTriple Negative Breast NeoplasmsAdultAgedFemaleHumansMiddle AgedNeoplasm MetastasisAntibodies, Monoclonal, HumanizedBenzimidazolesbinimetinibpembrolizumab

Identifiers

PMID40053697
PMCPMC12079099

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.