Evidence map›Paper›PMID 38725995›Full record

ArticleNeuro-oncology advances

POLARIS: A phase 2 trial of encorafenib plus binimetinib evaluating high-dose and standard-dose regimens in patients with

Alexander M Menzies, Georgina V Long, Amiee Kohn, Hussein Tawbi, Jeffrey Weber, Keith Flaherty, Grant A McArthur, Paolo A Ascierto, Yanina Pfluger, Karl Lewis and 10 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03911869 (A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03911869 phase2terminatednot on this map

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis

TypeinterventionalSponsorPfizerRan2019 to 2022Enrolled13ConditionsBrain MetastasesArmsencorafenib, binimetinib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. A Review on Melanoma Brain Metastases.Current pharmaceutical design · 2026
    Review
  2. Review
  3. Review
  4. Review
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.

Alexander M MenziesMelanoma Institute Australia, NSW, Australia, and The University of Sydney, Sydney, Australia.
Georgina V LongMelanoma Institute Australia, NSW, Australia, and The University of Sydney, Sydney, Australia.
Amiee KohnDivision of Hematology/Medical Oncology, School of Medicine, Oregon Health Sciences University, Portland, Oregon, USA.
Hussein TawbiDepartment of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID https://orcid.org/0000-0003-1942-851X
Jeffrey WeberLaura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.
Keith FlahertyMassachusetts General Cancer Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
Grant A McArthurSir Peter MacCallum Department of Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
Paolo A AsciertoUnit of Melanoma Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Yanina PflugerAlexander Fleming Institute, Buenos Aires, Argentina.
Karl LewisMedical Oncology, University of Colorado, Health Center, Denver, Colorado, USA.
Katy K TsaiHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA.
Omid HamidThe Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate Los Angeles, California, USA.
Hans PrenenOncology Department, University Hospital Antwerp, Antwerp, Belgium.ORCID https://orcid.org/0000-0001-8802-7352
Luis FeinAlexander Fleming Institute, Buenos Aires, Argentina.
Erjian WangFormerly Pfizer, New York, New York, USA.
Carolin GuenzelFormerly Pfizer, New York, New York, USA.
Fan ZhangFormerly Pfizer, New York, New York, USA.
Joseph F KlehaFormerly Pfizer, New York, New York, USA.
Alessandra di PietroPfizer Srl, Milan, Italy.
Michael A DaviesDepartment of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: POLARIS (phase 2 [ph2]; NCT03911869) evaluated encorafenib (BRAF inhibitor) in combination with binimetinib (MEK1/2 inhibitor) in BRAF/MEK inhibitor-naïve patients with Methods: The safety lead-in (SLI) assessed tolerability for high-dose encorafenib 300 mg twice daily (BID) plus binimetinib 45 mg BID. If the high dose was tolerable in ph2, patients would be randomized to receive high or standard dose (encorafenib 450 mg once daily [QD] plus binimetinib 45 mg BID). Otherwise, standard dose was evaluated as the recommended ph2 dose (RP2D). Patients who tolerated standard dosing during Cycle 1 could be dose escalated to encorafenib 600 mg QD plus binimetinib 45 mg BID in Cycle 2. Safety, efficacy, and pharmacokinetics were examined. Results: RP2D was standard encorafenib dosing, as >33% of evaluable SLI patients (3/9) had dose-limiting toxicities. Overall, of 13 safety-evaluable patients (10 SLI, 3 ph2), 9 had prior immunotherapy. There were 9 treatment-related adverse events in the SLI and 3 in ph2. Of the SLI efficacy-evaluable patients ( Conclusions: Despite small patient numbers due to early trial termination, BMRR appeared similar between the SLI and ph2, and the ph2 safety profile appeared consistent with previous reports of standard-dose encorafenib in combination with binimetinib.

Indexed as

BinimetinibBRAF V600EncorafenibMelanomaPOLARIS

Identifiers

PMID38725995
PMCPMC11079948

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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.