Evidence map›Paper›PMID 34916216›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

Melanie Royce, Christy L Osgood, Anup K Amatya, Mallorie H Fiero, C J George Chang, Tiffany K Ricks, Krithika A Shetty, Jeffrey Kraft, Junshan Qiu, Pengfei Song and 27 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
3.2field-weighted citation impact, top 6% 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.

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

22 citing papers in PubMed, 39 citations in OpenAlex.

  1. A First-in-Class mAb (BI-1607) Targeting FcγRIIB: Preclinical Data and First-in-Human Studies in Patients with HER2-Positive Advanced Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. The History and Development of HER2 Inhibitors.Pharmaceuticals (Basel, Switzerland) · 2023
    Review
  13. Beyond Neoantigens: Antigens Derived from Tumor Drivers as Cancer Vaccine Targets.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  14. Review
  15. Review
  16. Targeting Breast Cancer: An Overlook on Current Strategies.International journal of molecular sciences · 2023
    Review
  17. Article
  18. Review
  19. Review
  20. 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

37 authors at 1 institution in 1 country.

Melanie RoyceCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-7173-1295
Christy L OsgoodCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Anup K AmatyaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Mallorie H FieroCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
C J George ChangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Tiffany K RicksCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Krithika A ShettyCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jeffrey KraftCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Junshan QiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Pengfei SongCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Rosane CharlabCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jingyu YuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kathryn E KingCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-6357-0930
Anshu RastogiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Brian JanelsinsCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Wendy C WeinbergCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-8299-7339
Kathleen ClouseCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Vicky Borders-HemphillCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Lindsey BrownCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Candace Gomez-BroughtonCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Zhong LiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Thuy Thanh NguyenCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Zhihao QiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Anh-Thy LyCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Suyoung ChangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Tingting GaoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Chi-Ming TuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Bellinda King-KallimanisCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
William F PierceCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kelly ChiangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clara LeeCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kirsten B GoldbergCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-8659-1240
John K LeightonCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Shenghui TangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Richard PazdurOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Julia A BeaverCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
United States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with HER2-positive (HER2+) metastatic breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Approval was based on data from SOPHIA, a multicenter, randomized, open-label, active controlled study comparing margetuximab with trastuzumab, in combination with chemotherapy. The primary efficacy endpoint was progression-free survival (PFS) by blinded independent central review. SOPHIA demonstrated a 0.9-month difference in median PFS between the two treatment arms [5.8 vs. 4.9 months, respectively; stratified HR, 0.76 (95% confidence interval: 0.59-0.98; P = 0.0334)]. Overall survival (OS) was immature at the data cut-off date of September 10, 2019. Infusion-related reactions (IRR) are an important safety signal associated with margetuximab plus chemotherapy. In SOPHIA, 13% of patients treated with margetuximab plus chemotherapy reported IRRs, of which 1.5% were grade 3. The most commonly reported adverse drug reactions (>10%) with margetuximab in combination with chemotherapy were fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, IRR, palmar-plantar erythrodysesthesia, and extremity pain. Overall, the favorable risk-benefit profile for margetuximab when added to chemotherapy supported its approval for the intended indication.

Indexed as

Breast NeoplasmsAdultAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsDrug ApprovalErb-b2 Receptor Tyrosine KinasesFemaleHumansTrastuzumabAntibodies, MonoclonalErb-b2 Receptor Tyrosine KinasesmargetuximabTrastuzumab

Identifiers

PMID34916216
PMCPMC9012688
OpenAlexW4200438498

What OpenQuestion holds

Textmetadata
LicenceTDM
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.