Evidence map›Paper›PMID 34158360›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study.

Paolo A Ascierto, Brigitte Dréno, James Larkin, Antoni Ribas, Gabriella Liszkay, Michele Maio, Mario Mandalà, Lev Demidov, Daniil Stroyakovskiy, Luc Thomas and 10 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01689519 (A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma), which is not on this map. Cited by 101 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 2 pooled it
10.2field-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.

NCT01689519 phase3completednot on this map

A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

TypeinterventionalSponsorHoffmann-La RocheRan2013 to 2019Enrolled495ConditionsMalignant MelanomaArmsPlacebo, Vemurafenib, Cobimetinib
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 2 syntheses or guidelines pooled it, 175 citations in OpenAlex.

  1. Pooled it
  2. SEOM-GEM clinical guidelines for cutaneous melanoma (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  3. Trial
  4. Phase II Trial of Dabrafenib Plus Trametinib in Relapsed/RefractoryJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  5. Efficacy and Safety of Trametinib Monotherapy or in Combination With Dabrafenib in PediatricJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  6. COLUMBUS 5-Year Update: A Randomized, Open-Label, Phase III Trial of Encorafenib Plus Binimetinib Versus Vemurafenib or Encorafenib in Patients WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  7. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib forJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Retreatment and rechallenge with BRAF/MEK inhibitors in patients with metastatic melanoma: results from the real-world Spanish Melanoma Registry (GEM-1801).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Observational
  17. Article
  18. Review
  19. Article
  20. Article

41 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

20 authors at 18 institutions in 10 countries.

Paolo A AsciertoIstituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.ORCID 0000-0002-8322-475X
Brigitte DrénoUniversity of Nantes, Nantes, France.
James LarkinThe Royal Marsden Hospital, London, UK.
Antoni RibasJonsson Comprehensive Cancer Center at the University of California at Los Angeles, Los Angeles, CA, USA.
Gabriella LiszkayNational Institute of Oncology, Budapest, Hungary.ORCID 0000-0001-6161-2033
Michele MaioAzienda Ospedaliera Universitaria Senese, Siena, Italy.
Mario MandalàPapa Giovanni XXIII Hospital, Bergamo, Italy.
Lev DemidovN.N. Blokhin Russian Cancer Research Center, Moscow, Russia.ORCID 0000-0002-8562-6082
Daniil StroyakovskiyMoscow City Oncology Hospital 62, Krasnogorsk, Russia.
Luc ThomasCentre Hospitalier Lyon Sud, Pierre-Bénite, France.ORCID 0000-0003-1995-2434
Luis de la Cruz-MerinoHospital Universitario Virgen Macarena, Seville, Spain.
Victoria AtkinsonPrincess Alexandra Hospital, Woolloongabba, Queensland, Australia; Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia; and University of Queensland, St. Lucia, Queensland, Australia.
Caroline DutriauxHôpital Saint André, Bordeaux, France.
Claus GarbeUniversity of Tübingen, Tübingen, Germany.ORCID 0000-0001-8530-780X
Jessie HsuGenentech, a Member of the Roche Group, South San Francisco, California.
Surai JonesGenentech, a Member of the Roche Group, South San Francisco, California.
Haocheng LiF. Hoffmann-La Roche Ltd, Mississauga, ON, Canada.
Edward McKennaGenentech, a Member of the Roche Group, South San Francisco, California.
Athina VoulgariRoche Products Ltd, Welwyn Garden City, UK.
Grant A McArthurPeter MacCallum Cancer Centre and the University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0001-8908-6071
Colorado Permanente Medical Group · USAzienda Ospedaliera Universitaria Senese · ITBernstein Center for Computational Neuroscience Tübingen · DEHôpital Lyon Sud · FRHôpital Saint-André · FRHospital Universitario Virgen Macarena · ESIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITLaboratoire de Thermique et Energie de Nantes · FRMoscow City Oncology Hospital №62 · RUNational Institute of Oncology · HUOspedale Papa Giovanni XXIII · ITPeter MacCallum Cancer Centre · AURoche (Canada) · CARoche (United Kingdom) · GBRoyal Marsden Hospital · GBRussian Cancer Research Center NN Blokhin · RUThe University of Queensland · AUUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation-positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized. PATIENTS AND

methodsEligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1-21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily).

results495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3-28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0-19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5-14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6-7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports.

conclusionsExtended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation-positive advanced melanoma.

Indexed as

MelanomaSkin NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsAzetidinesFollow-Up StudiesHumansMutationPiperidinesProto-Oncogene Proteins B-rafVemurafenibAzetidinescobimetinibPiperidinesProto-Oncogene Proteins B-rafVemurafenib

Identifiers

PMID34158360
PMCPMC9401485
OpenAlexW3173401695

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.