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    DRUG:

    Ojemda (tovorafenib)

    i
    Other names: DAY101, MLN2480, BIIB024, TAK 580, TAK580, MLN 2480, MLN-2480, BIIB 024, BIIB-024, AMG 2112819, AMG2112819, AMG-2112819, TAK-580, DAY 101, DAY-101
    Company:
    Ipsen, Servier, Takeda, Xoma
    Drug class:
    pan-RAF inhibitor
    Related drugs:
    24d
    Rebound regrowth phenomenon in patients with pediatric low-grade gliomas treated with MAPK inhibitors - a systematic review. (PubMed, Oncol Rev)
    RR is a reproducible and clinically relevant phenomenon following MAPKi discontinuation in pLGG. Standardized definitions, structured post-discontinuation surveillance, and prospective evaluation of treatment duration and dose-tapering strategies are needed to optimize MAPKi discontinuation and long-term disease management in patients with pLGG.
    Review • Journal
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    BRAF (B-raf proto-oncogene) • NF1 (Neurofibromin 1)
    |
    BRAF V600E • BRAF V600
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    Mekinist (trametinib) • Zelboraf (vemurafenib) • Tafinlar (dabrafenib) • Koselugo (selumetinib) • Ojemda (tovorafenib)
    1m
    A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours (clinicaltrials.gov)
    P1, N=6, Recruiting, Ipsen | Not yet recruiting --> Recruiting
    Enrollment open
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    BRAF (B-raf proto-oncogene) • KIAA1549
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    BRAF mutation • BRAF V600 • BRAF fusion
    |
    Ojemda (tovorafenib)
    3ms
    PNOC029_Tovorafenib for the treatment of newly diagnosed or recurrent craniopharyngioma in children and young adults (2024-511510-20-00)
    P1/2, N=5, Not yet recruiting, Prinses Maxima Centrum voor Kinderoncologie B.V.
    New P1/2 trial
    |
    Ojemda (tovorafenib)
    3ms
    KiTZ-EPILOGUE-2024: Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE) (2024-516896-34-00)
    P1/2, N=31, Not yet recruiting, Universitaetsklinikum Heidelberg AR
    New P1/2 trial
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    BRAF (B-raf proto-oncogene) • KIAA1549
    |
    BRAF V600E • BRAF V600 • BRAF fusion
    |
    Ojemda (tovorafenib)
    3ms
    KiTZ-EPILOGUE-2024: Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE) (2024-516896-34-00)
    P1/2, N=28, Not yet recruiting, Universitaetsklinikum Heidelberg AR
    New P1/2 trial
    |
    BRAF (B-raf proto-oncogene) • KIAA1549
    |
    BRAF V600E • BRAF V600 • BRAF fusion
    |
    Ojemda (tovorafenib)
    3ms
    DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) (clinicaltrials.gov)
    P3, N=400, Recruiting, Day One Biopharmaceuticals, Inc. | Trial completion date: Mar 2030 --> Jun 2031 | Trial primary completion date: Feb 2026 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    carboplatin • Ojemda (tovorafenib)
    3ms
    A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Ipsen
    New P1 trial
    |
    BRAF (B-raf proto-oncogene) • KIAA1549
    |
    BRAF mutation • BRAF V600 • BRAF fusion
    |
    Ojemda (tovorafenib)
    3ms
    From Diagnosis Delay to Targeted Therapy: A Retrospective Study of Pediatric DLGNT with a Comprehensive Literature Review. (PubMed, Cancers (Basel))
    The median number of therapeutic lines was four: 82% received chemotherapy (weekly vinblastine in 55%, vincristine/carboplatin regimen in 45%), 64% received MAPK pathway-targeted therapy, and 18% underwent radiotherapy...Conventional low-grade glioma chemotherapy constitutes the current treatment backbone, while MAPK pathway-targeted therapies show promising potential. Further studies and the establishment of an international registry are crucial to better characterize aggressive subtypes and optimize management strategies.
    Retrospective data • Journal
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    BRAF (B-raf proto-oncogene) • KIAA1549
    |
    carboplatin • vincristine • Ojemda (tovorafenib) • vinblastine
    4ms
    PNOC014: DAY101 In Gliomas and Other Tumors (clinicaltrials.gov)
    P1, N=44, Completed, Karen D. Wright, MD | Active, not recruiting --> Completed
    Trial completion
    |
    NF1 (Neurofibromin 1)
    |
    Ojemda (tovorafenib)
    4ms
    Aggressive infantile melanoma arising in a congenital nevus with rare BRAF and BCOR mutations: a case report and literature review of pediatric melanoma. (PubMed, Dermatol Reports)
    Treatment included surgery and systemic therapies (nivolumab and ipilimumab, followed later by tovorafenib). The patient's clinical course was marked by aggressive local progression and therapeutic challenges. This case highlights the rarity of such presentations and the need for further research into the clinicopathological and molecular features of infantile melanoma arising in congenital melanocytic nevus (CMN).
    Journal • PD(L)-1 Biomarker
    |
    BRAF (B-raf proto-oncogene) • BCOR (BCL6 Corepressor)
    |
    BRAF mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Ojemda (tovorafenib)
    4ms
    Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab-Tuvorilimab for Advanced Gallbladder Cancer (ChiCTR2600117584)
    P2, N=44, Not yet recruiting, Xinhua Hospital Affiliated to Shanghai Jiaotong University of Medicine; Xinhua Hospital Affiliated to Shanghai Jiaotong University of Medicine
    New P2 trial
    |
    gemcitabine • albumin-bound paclitaxel • Ojemda (tovorafenib) • iparomlimab (QL1604)
    6ms
    Harnessing retinoic acid metabolism-related genes to identify lung adenocarcinoma subtype and establish a risk model for predicting prognosis and drug therapy response. (PubMed, Comput Biol Chem)
    RAMRGs serve as useful biomarkers to predict prognosis in LUAD patients, and may guide the immunotherapy regimen.
    Journal • IO biomarker
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    TP53 (Tumor protein P53) • CYP17A1 (Cytochrome P450 Family 17 Subfamily A Member 1) • IGF2BP1 (Insulin Like Growth Factor 2 MRNA Binding Protein 1) • IGFBP1 (Insulin Like Growth Factor Binding Protein 1)
    |
    Zelboraf (vemurafenib) • Tafinlar (dabrafenib) • lifirafenib (BGB-283) • Ojemda (tovorafenib)