Evidence map›Paper›PMID 36335120›Full record

ArticleNPJ breast cancer2022

Abemaciclib in combination with pembrolizumab for HR+, HER2- metastatic breast cancer: Phase 1b study.

Hope S Rugo, Peter Kabos, J Thad Beck, Guy Jerusalem, Hans Wildiers, Elena Sevillano, Luis Paz-Ares, Michael J Chisamore, Sonya C Chapman, Anwar M Hossain and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02779751 (A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer), which is not on this map. Cited by 69 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 2 pooled it
10.6field-weighted citation impact, top 1% of its field
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.

NCT02779751 phase1active not recruitingnot on this map

A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2026Enrolled100ConditionsNon Small Cell Lung Cancer, Breast CancerArmsAbemaciclib, Pembrolizumab, Anastrozole
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Pembrolizumab and Paclitaxel in Patients with HR+/HER2- Breast Cancer with HER2-Enriched or Basal-like Subtypes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. The immunology of human breast cancer.Nature reviews. Immunology · 2026
    Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. CDK4/6 Inhibition Induces CD8Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  17. Article
  18. Review
  19. Review
  20. Review

9 more citing papers are in PubMed but not listed here.

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

12 authors at 11 institutions in 4 countries.

Hope S RugoUniversity of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. Hope.Rugo@ucsf.edu.ORCID http://orcid.org/0000-0001-6710-4814
Peter KabosDivisions of Medical Oncology, Department of Medicine, University of Colorado, Anschutz Medical Campus, 12801 East 17th Avenue, Aurora, CO, 80045, USA.
J Thad BeckHighlands Oncology Group, Fayetteville, AR, USA.
Guy JerusalemLaboratory of Medical Oncology, University of Liège, Liège, Belgium.
Hans WildiersDepartment of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0001-8990-7837
Elena SevillanoDepartment of Medical Oncology, Centro Integral Oncologico Clara Campal, Madrid, Spain.
Luis Paz-AresHospital Universitario 12 de Octubre, CNIO-H120 Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.
Michael J ChisamoreDepartment of Clinical Research, Merck & Co., Inc., Rahway, NJ, USA.
Sonya C ChapmanEli Lilly and Company, Bracknell, UK.ORCID http://orcid.org/0000-0002-6453-2749
Anwar M HossainEli Lilly and Company, Indianapolis, IN, USA.
Yanyun ChenEli Lilly and Company, Indianapolis, IN, USA.
Sara M TolaneyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID http://orcid.org/0000-0002-5940-8671
Eli Lilly (United States) · USCentro Oncológico de Galicia · ESDana-Farber Cancer Institute · USEli Lilly (United Kingdom) · GBHighlands Oncology Group · USHospital Universitario 12 De Octubre · ESKU Leuven · BEMerck & Co., Inc., Rahway, NJ, USA (United States) · USUniversity of California, San Francisco · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Liège · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This nonrandomized, open-label, multi-cohort Phase 1b study (NCT02779751) investigated the safety and efficacy of abemaciclib plus pembrolizumab with/without anastrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) without prior CDK4 and 6 inhibitor exposure. Patients were divided into two cohorts: treatment naïve (cohort 1) and pretreated (cohort 2). Patients received abemaciclib plus pembrolizumab with (cohort 1) or without (cohort 2) anastrozole over 21-day cycles. The primary objective was safety, and secondary objectives included efficacy and pharmacokinetics (PK). Cohort 1/2 enrolled 26/28 patients, respectively. Neutropenia (30.8/28.6%), AST increase (34.6/17.9%), ALT increase (42.3/10.7%), and diarrhea (3.8/10.7%) were the most frequent grade ≥3 adverse events in cohort 1/2, respectively. A total of two deaths occurred, which investigators attributed to treatment-related adverse events (AEs), both in cohort 1. Higher rates of all grade and grade ≥3 interstitial lung disease (ILD)/pneumonitis were observed compared to previously reported with abemaciclib and pembrolizumab monotherapy. The PK profiles were consistent between cohorts and with previous monotherapy studies. In cohorts 1/2, the overall response rate and disease control rate were 23.1/28.6% and 84.6/82.1%, respectively. Median progression-free survival and overall survivals were 8.9 (95% CI: 3.9-11.1) and 26.3 months (95% CI: 20.0-31.0) for cohort 2; cohort 1 data are immature. Abemaciclib plus pembrolizumab demonstrated antitumor activity, but high rates of ILD/pneumonitis and severe transaminase elevations occurred with/without anastrozole compared to the previous reporting. Benefit/risk analysis does not support further evaluation of this combination in the treatment of HR+, HER2- MBC.

Identifiers

PMID36335120
PMCPMC9637121
OpenAlexW4308308471

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.