Voranigo (vorasidenib)
/ Servier, Royalty
- LARVOL DELTA
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July 17, 2026
Real-world efficacy and safety of vorasidenib in IDH-mutant grade 2 gliomas: a multicenter study from Spain
(ESMO 2026)
- No abstract available
Clinical • Real-world • Real-world effectiveness • Real-world evidence • Brain Cancer • Glioma • Oncology • Solid Tumor
May 28, 2026
Assessment of IDH-Mutated Glioma Treatment Response to Long-Term Targeted Therapy by Longitudinal Tumor Volume Measurements
(ASTRO 2026)
- "Vorasidenib (Vora), a dual mutant IDH1 and IDH2 inhibitor was recently FDA approved for recurrent IDH mutant (mIDH) glioma after demonstrating an improvement in progression free survival. Ivosidenib (Ivo), an mIDH1 inhibitor has also been used for mIDH glioma treatment...Four of 13 (31%) had a prior history of radiation therapy, 3 of 13 (23%) had been treated with chemotherapy (2 with temozolomide, 1 with PCV)... Most patients (12 of 13, 92%) who remain on long-term Ivo for greater than 36 months had radiographically stable disease; one patient had progressive disease after 36 months of treatment with Ivo. Based on results from this small cohort, long-term Ivo therapy may help to control tumor growth longitudinally and delay the initiation of chemoRT for some patients. Future studies will seek to further define long-term impact of mIDHi therapy on overall survival and role in delaying initial or repeat chemoRT."
Astrocytoma • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor • IDH1
July 17, 2026
Predictors of Early Progression in IDH-Mutant Gliomas Treated with Vorasidenib: A Real-World Study from the Spanish RETSINE-GEINO Registry
(ESMO 2026)
- No abstract available
Clinical • Real-world • Real-world evidence • Brain Cancer • Glioma • Oncology • Solid Tumor
July 17, 2026
Early metabolic response and seizure control with vorasidenib in IDH-mutant gliomas: real-world results from the VORAFET study
(ESMO 2026)
- No abstract available
Clinical • Real-world • Real-world evidence • Brain Cancer • Glioma • Oncology • Solid Tumor
July 17, 2026
Non-invasive finger sweat-based response monitoring of vorasidenib treatment in patients with IDH-mutant glioma
(ESMO 2026)
- No abstract available
Clinical • Non-invasive • Brain Cancer • Glioma • Oncology • Solid Tumor
July 17, 2026
Early predictors of vorasidenib efficacy in IDH-mutant grade 2 glioma: a prospective study integrating volumetric MRI, amino acid PET, plasma D-2-hydroxyglutarate, and seizure outcome
(ESMO 2026)
- No abstract available
Clinical • Brain Cancer • Glioma • Oncology • Solid Tumor
September 25, 2026
Diagnosis and treatment decision of an IDH-mutant glioma through CSF-based cfDNA sequencing.
(PubMed, Neurooncol Adv)
- "The patient was initially treated with vorasidenib, an IDH inhibitor, which was then switched to a procarbazine-CCNU chemotherapy due to clinical worsening under initial therapy. CSF-based cfDNA sequencing is a promising tool for minimally invasive diagnosis of tumors of the CNS in situations in which tissue biopsy is challenging or non-informative."
Journal • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor • IDH1 • TERT
August 15, 2026
Single-Center Experience with Vorasidenib in Patients with Grade 3 or 4 IDH-Mutant Gliomas
(EANO 2026)
- "Prior treatments included surgical resection (47, 84%), radiation (45, 80%), temozolomide (44, 78%), ivosidenib (13, 23%), bevacizumab (11, 20%), lomustine (10, 18%), lomustine + procarbazine (7, 13%), and pembrolizumab (4, 7%). In this heavily pre-treated cohort of patients with high-grade IDH mutant gliomas, vorasidenib was well-tolerated and associated with promising 6 and 12-month PFS rates. Optimal role of the agent in the treatment of high-grade gliomas requires prospective evaluation."
Clinical • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oligodendroglioma • Oncology • Solid Tumor
August 05, 2026
Preserving and Targeting IDH Mutations in Glioma: From Patient-Derived Models to Organoid Systems and Liquid Biopsy Monitoring
(EANO 2026)
- "Functional studies were performed in primary cells as well as in TB096 and BT142 models using the mutant IDH inhibitor Vorasidenib and the PARP inhibitor Olaparib, applied alone and in combination. These findings underscore the importance of preserving IDH mutations for biologically relevant glioma models. Organoid-based systems support maintenance of tumor-specific features and enable functional studies in a more physiological context. In parallel, liquid biopsy allows sensitive, non-invasive detection of IDH mutations."
Biopsy • Clinical • Liquid biopsy • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor
August 15, 2026
Disentangling disease from drug: neurological adverse events with IDH inhibitors in glioma
(EANO 2026)
- "Extracted outcomes focused on the incidence, severity, and characterization of neurological adverse events, with particular attention to reporting methodology and attribution. Across phase I-III trials of IDH inhibitors—including vorasidenib, ivosidenib, olutasidenib, and safusidenib—neurological adverse events were commonly reported, with headache being the most frequent (approximately 13-46%). The interpretation of neurological adverse events in IDH-mutant gliomas is limited by significant methodological heterogeneity, lack of standardized symptom reporting, and confounding from tumor-related manifestations and prior therapies. Neurological adverse events in IDH inhibitor-treated glioma patients are common but undercharacterized. Available evidence suggests that some symptoms-particularly headache-may reflect the underlying disease rather than drug toxicity, at least in certain contexts."
Adverse events • Brain Cancer • Glioma • Oncology • Solid Tumor
August 15, 2026
Targeting mTOR enhances the effects of vorasidenib in IDH-mutant astrocytomas
(EANO 2026)
- "These findings identify mTOR signaling as a targetable vulnerability in vorasidenib-treated IDH-mutant gliomas and supports combination therapy as a strategy to improve therapeutic outcomes."
Astrocytoma • Brain Cancer • Diffuse Glioma • Oncology • Solid Tumor • BCAT1 • IDH1 • IDH2
September 19, 2026
Emerging role of targeted therapy in drug-resistant epilepsy in patients with glioma.
(PubMed, Curr Opin Oncol)
- "Targeted agents are emerging as disease-modifying options that may also reduce seizure burden, but seizure freedom must be tested in future trials as a prespecified endpoint rather than inferred from exploratory analyses."
Journal • Brain Cancer • CNS Disorders • Epilepsy • Glioma • Glioneuronal Tumor • Oncology • Solid Tumor • IDH1 • IDH2
September 09, 2026
Alliance A072301: A Phase III trial of radiotherapy followed by adjuvant temozolomide in combination with vorasidenib vs placebo in IDH-mutated newly diagnosed grade 3 astrocytoma (VORTEX)
(SNO 2026)
- No abstract available
Clinical • Combination therapy • P3 data • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Oncology • Solid Tumor
August 15, 2026
Dual Molecularly Distinct IDH-Mutant Diffuse Gliomas in a Single Patient: Evidence for Multicentric Gliomagenesis and Therapeutic Implications of Targeted IDH Inhibition
(EANO 2026)
- "The patient subsequently received radiation therapy with concomitant temozolomide followed by 12 cycles of adjuvant chemotherapy.From the time of initial diagnosis, a non-enhancing contralateral temporal lesion was noted...Given bilateral diffuse disease and emerging therapeutic paradigms, treatment with the CNS-penetrant IDH inhibitor Vorasidenib was initiated. The presence of separate IDH-mutant gliomas with divergent molecular features in a single patient is uncommon and raises important considerations regarding tumorigenesis, surveillance strategies, and treatment selection. The presence of separate IDH-mutant gliomas with divergent molecular features in a single patient is uncommon and raises important considerations regarding tumorigenesis, surveillance strategies, and treatment selection. Molecular confirmation of new or progressive lesions is critical, particularly in the era of targeted therapies. This case highlights the potential role of IDH inhibition in..."
Clinical • Astrocytoma • Brain Cancer • Diffuse Glioma • Glioma • Oligodendroglioma • Oncology • Solid Tumor
September 09, 2026
Safety outcomes from Phase 1b/2 study of vorasidenib in combination with temozolomide in patients with high-grade mutant IDH1 or IDH2 glioma (IDHEAL-4U)
(SNO 2026)
- No abstract available
Clinical • Combination therapy • P1/2 data • Brain Cancer • Glioma • Solid Tumor • IDH1 • IDH2
August 05, 2026
Trial in progress: a Phase 2 trial of vorasidenib in combination with temozolomide in patients with grade 4 mutant IDH1 or IDH2 astrocytoma (IDHEAL-4U)
(EANO 2026)
- P1/2 | "After completion or discontinuation of TMZ, pts may continue to receive vorasidenib until disease progression, unacceptable toxicity or other discontinuation criteria are met.The primary objective is to evaluate safety, tolerability and clinical efficacy of vorasidenib + TMZ treatment as assessed by incidence and severity of adverse events (AEs), serious AEs and AEs of special interest and progression-free survival (PFS) rate at 12 months. Secondary objectives include assessing other clinical efficacy parameters based on PFS, overall survival, overall response and clinical benefit and characterizing the pharmacokinetics of vorasidenib when given alone and in combination with TMZ.As of November 2025, enrolment is complete, with 44 pts enrolled and who have received at least one dose of study drug combination.Phase 2 of the IDHEAL-4U study will provide preliminary efficacy and safety data to inform future investigations of this combination."
Clinical • Combination therapy • P2 data • Astrocytoma • Brain Cancer • Oncology • Solid Tumor • IDH1 • IDH2
August 05, 2026
Leveraging a genetic mouse model of IDH-mutant glioma to understand molecular responses to vorasidenib therapy
(EANO 2026)
- "At time of tumor progression on MRI, mice were randomized to either continue vorasidenib through concurrent radiation (RT) and temozolomide (TMZ), or stop vorasidenib prior to RT/TMZ. Our data leverage a genetic model of IDH-mutant glioma that can be used to study efficacy of treatments involving vorasidenib and molecular drivers of response and resistance to vorasidenib. Data from our GEMM do not identify genetic resistance mechanisms to vorasidenib, suggesting that resistance may be transcriptionally driven. We additionally do not observe antagonism between vorasidenib and chemoradiation when delivered concurrently."
Preclinical • Astrocytoma • Brain Cancer • Glioma • Oncology • Solid Tumor • ATRX • IDH1 • IDH2 • PIK3CA • TP53
August 15, 2026
Real-world utilization of vorasidenib among patients with grade 2 IDH-mutant gliomas in the USA
(EANO 2026)
- "Almost all pts received vorasidenib monotherapy (n=229, 99.1%), one received vorasidenib in combination with temozolomide and one received vorasidenib in combination with lomustine. This initial real-world analysis, conducted within ~18 months of vorasidenib approval, characterizes pt demographics and early clinical outcomes. The study demonstrates vorasidenib utilization, early tolerability and effectiveness in a heterogeneous grade 2 mIDH glioma population with evidence of durable use. These findings are consistent with those observed in the INDIGO trial."
Clinical • Real-world • Real-world evidence • Astrocytoma • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor • IDH1 • IDH2
September 18, 2026
Redefining Care for IDH-Mutant Low-Grade Gliomas: Clinical Implications of the INDIGO Trial and Updated Guidelines.
(PubMed, Clin Med (Lond))
- "The side-effect profile was tolerable compared to that of traditional cytotoxic chemotherapies. In August 2024, vorasidenib received FDA approval for the treatment of grade 2 mIDH gliomas and is included in the National Comprehensive Cancer Network Guidelines for central nervous system tumours."
Journal • Review • Astrocytoma • Brain Cancer • CNS Tumor • Glioma • Low Grade Glioma • Oligodendroglioma • Oncology • Solid Tumor • IDH1 • IDH2
September 09, 2026
A Phase 2 study evaluating the efficacy and safety of safusidenib in Grade 2 or 3 isocitrate dehydrogenase 1 (IDH1)-mutant glioma after disease progression (PD) on vorasidenib
(SNO 2026)
- No abstract available
Clinical • P2 data • Brain Cancer • Glioma • Solid Tumor • IDH1
September 09, 2026
CTCAE-graded feasibility and safety of concurrent vorasidenib and FOLFOX in progressive IDH-mutant astrocytoma in the setting of dual active malignancies
(SNO 2026)
- No abstract available
Clinical • Astrocytoma • Brain Cancer • Oncology • Solid Tumor
September 13, 2026
"The Danish Medical Council recommends vorasidenib for the treatment of adult and adolescent patients from 12 years of age with IDH1- or IDH2-mutated astrocytoma or oligodendroglioma WHO grade 2, who have undergone surgical treatment only and who do not require immediate radiotherapy or chemotherapy."
(Danish Medicines Council)
- "The Medical Council emphasizes that vorasidenib can significantly delay disease progression compared to active observation. The costs of the treatment are higher than the existing treatment, but the Medical Council assesses that the costs are acceptable in relation to the effect of the treatment. Treatment with vorasidenib entails drug costs of approximately DKK 6.7 million for an average treatment course of approximately 5.3 years. Compared to the existing treatment, vorasidenib entails additional costs of approximately DKK 6.4 million per patient. The costs are based on public list prices."
Reimbursement • Astrocytoma • Oligodendroglioma • Oncology
September 09, 2026
Infiltrating tumour cell populations adopt conserved transcriptional programs in IDHmt diffuse adult glioma that are manipulated by vorasidenib
(SNO 2026)
- No abstract available
Clinical • Tumor cell • Brain Cancer • Glioma • Oncology • Solid Tumor
September 12, 2026
Vorasidenib-Induced Acute Liver Injury.
(PubMed, Dig Dis Sci)
- "Data suggest that vorasidenib-induced liver injury is hepatocellular with a subset that presents with autoimmune-like features which responds to a finite course of corticosteroids."
Journal • Astrocytoma • Autoimmune Hepatitis • Brain Cancer • Glioma • Hepatology • Immunology • Inflammation • Liver Failure • Oligodendroglioma • Oncology • Solid Tumor • IDH1
August 15, 2026
The Role of Advanced Nurse Practitioners in Managing Patients on Managed Access Programmes (MAPs) in Neuro‑Oncology
(EANO 2026)
- "With the growing availability of innovative therapies in Neuro‑Oncology for example Vorasidenib and Eflornithine, MAP activity has increased substantially... Toxicities were common, with 29 of 30 patients (97%) experiencing at least one adverse event (AE). The most frequent toxicities were grade 1 transaminitis (n=16, 53%), grade 2 transaminitis (n=4, 13.3%), grade 3 transaminitis (n=3, 10%), grade 4 transaminitis (n=3, 10%), and grade 1-2 diarrhoea (n=4, 13.3%). Three patients (10%) permanently discontinued treatment: one due to severe toxicity, one due to disease progression, and one due to death."
Clinical • Metastases • Oncology
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