Evidence map›Paper›PMID 41206766›Full record

Trial reportNeuro-oncology2026

Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naïve isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas.

Yoshiki Arakawa, Ryuta Saito, Yonehiro Kanemura, Kazuhiko Mishima, Shunichi Koriyama, Yoshitaka Narita, Toshihiro Kumabe, Kazuya Motomura, Kazuhiko Sugiyama, Fumiyuki Yamasaki and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Neuro-oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04458272 (A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04458272 phase2active not recruitingnot on this map

A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2020 to 2026Enrolled25ConditionsWHO Grade II GliomaArmsDS-1001b
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Current and emerging therapies in IDH-mutant glioma.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  3. 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

17 authors.

Yoshiki ArakawaDepartment of Neurosurgery, Graduate School of Medicine, Kyoto University, Kyoto (Y.A.).ORCID 0000-0003-4626-4645
Ryuta SaitoDepartment of Neurosurgery, Graduate School of Medicine, Nagoya University, Nagoya (R.S., K.Mo.).ORCID 0000-0002-2484-1360
Yonehiro KanemuraDepartment of Biomedical Research and Innovation, Institute for Clinical Research, Osaka (Y.Kan.).
Kazuhiko MishimaDepartment of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center, Hidaka (K.Mi.).
Shunichi KoriyamaDepartment of Neurosurgery, Tokyo Women's Medical University, Tokyo (S.K.).
Yoshitaka NaritaDepartment of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, Tokyo (Y.N.).ORCID 0000-0003-4303-6006
Toshihiro KumabeDepartment of Neurosurgery, Kitasato University School of Medicine, Sagamihara (T.K).
Kazuya MotomuraDepartment of Neurosurgery, Graduate School of Medicine, Nagoya University, Nagoya (R.S., K.Mo.).
Kazuhiko SugiyamaDepartment of Clinical Oncology & Neuro-Oncology Program, Hiroshima University Hospital, Hiroshima (K.S).
Fumiyuki YamasakiDepartment of Neurosurgery, Hiroshima University Hospital, Hiroshima (F.Y.).ORCID 0000-0003-0164-6295
Akitake MukasaDepartment of Neurosurgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto (A.M.).
Masayuki KanamoriDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai (M.K.).ORCID 0000-0002-3380-1192
Daisuke KugaDepartment of Neurosurgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka (D.K.).
Motoo NaganeDepartment of Neurosurgery, Kyorin University Faculty of Medicine, Tokyo (M.N.).ORCID 0000-0002-0018-1652
Yasuyuki KakuraiData Intelligence Department, Daiichi Sankyo Co., Ltd, Tokyo (Y.Kak.).
Koji IsobeClinical Science Department, Daiichi Sankyo Co., Ltd, Tokyo (K.I.).
Hideo NakamuraDepartment of Neurosurgery, Kurume University School of Medicine, Kurume (H.N.).

Funding

Daiichi Sankyo Co., Ltd.
6 · The paper itself

Abstract

backgroundGliomas are primary brain tumors arising from glial cells. WHO grade 2 gliomas are initially managed with surgery for diagnosis and tumor reduction. However, complete resection is difficult due to their infiltrative growth into the normal brain and the need to preserve brain function. Current treatment options for WHO grade 2 gliomas are limited. Isocitrate dehydrogenase 1 (IDH1) mutations are frequently observed in WHO grade 2 gliomas. Safusidenib erbumine is a selective inhibitor of mutant IDH1 with substantial blood-brain barrier penetration. This study aimed to investigate the efficacy and safety of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naïve IDH1-mutated WHO grade 2 gliomas.

methodsThis phase II study implemented a multicenter, open-label, single-arm design and evaluated the efficacy and safety of safusidenib erbumine in 27 patients with chemotherapy- and radiotherapy-naïve IDH1-mutated WHO grade 2 gliomas (NCT04458272).

resultsThe confirmed objective response rate according to the Response Assessment in Neuro-Oncology criteria for WHO grade 2 gliomas was 44.4%. Median progression-free survival was not reached, with an event-free probability of 87.9% at 24 months. The frequently reported treatment-emergent adverse events (TEAEs) by Medical Dictionary for Regulatory Activities Preferred Terms (reported in ≥40%) were alopecia (59.3%), arthralgia (55.6%), skin hyperpigmentation (48.1%), and alanine aminotransferase increased (40.7%). Treatment-emergent adverse events were characterized as mostly grade 1 or 2. The incidence of treatment-related grade ≥3 TEAEs was 18.5%.

conclusionsSafusidenib erbumine is a potential treatment option for patients with chemotherapy- and radiotherapy-naïve IDH1-mutated WHO grade 2 gliomas.

Indexed as

Brain NeoplasmsGliomaIsocitrate DehydrogenaseMutationAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm GradingPrognosisSurvival RateYoung AdultIDH1 protein, humanIsocitrate Dehydrogenasechemotherapy- and radiotherapy-naïvedelayed recurrence and progressiongrade 2 gliomasIDH1 inhibitorsafusidenib erbumine

Identifiers

PMID41206766
PMCPMC13070488

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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.