Therapy Detail

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Therapy Name Tovorafenib
Synonyms
Therapy Description

Ojemda (tovorafenib) is an inhibitor of pan-Raf kinases, which interrupts RAF/MEK/ERK signal transduction pathways to inhibit tumor cell growth (PMID: 28082416, PMID: 30622172). Ojemda (tovorafenib) is FDA approved for use in patients 6 months or older with relapsed or refractory pediatric low grade glioma harboring BRAF fusion or rearrangement or BRAF V600 mutation (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Tovorafenib Ojemda BIIB-024|TAK-580|MLN-2480|TAK580|DAY101|MLN2480 RAF Inhibitor (Pan) 27 Ojemda (tovorafenib) is an inhibitor of pan-Raf kinases, which interrupts RAF/MEK/ERK signal transduction pathways to inhibit tumor cell growth (PMID: 28082416, PMID: 30622172). Ojemda (tovorafenib) is FDA approved for use in patients 6 months or older with relapsed or refractory pediatric low grade glioma harboring BRAF fusion or rearrangement or BRAF V600 mutation (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF mutant melanoma sensitive Tovorafenib Phase I Actionable In a Phase I trial, Ojemda (tovorafenib) treatment resulted in stable disease in 23% (5/22) of patients with advanced solid tumors in the dose escalation phase, an objective response rate of 15% (10/68) in the dose expansion phase with responses in 50% (8/16) of patients with RAF and MEK inhibitor-naive BRAF-mutant melanoma, an overall median duration of response of 6.0 months, and a median progression-free survival of 1.9 months (PMID: 37219686; NCT01425008). 37219686
BRAF mutant melanoma sensitive Tovorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, Ojemda (tovorafenib) demonstrated efficacy in BRAF mutant xenograft models of melanoma and colorectal cancer (J Clin Oncol 31, 2013 (suppl; abstr e13529)). detail...
BRAF fusion childhood low-grade glioma sensitive Tovorafenib FDA approved Actionable In a Phase II trial (FIREFLY-1) that supported FDA approval, Ojemda (tovorafenib) was well tolerated and resulted in an overall response rate (ORR) per RAPNO criteria of 51% (39/76, 28 partial and 11 minor responses), clinical benefit rate (CBR) of 82% (62/76), and median duration of response of 13.8 mo in pediatric patients with low-grade glioma harboring BRAF fusions, rearrangements, or BRAF V600 mutations, with an ORR of 52% (33/64) in patients harboring BRAF fusions (PMID: 37978284; NCT04775485). detail... 37978284
BRAF mutant Advanced Solid Tumor predicted - sensitive Tovorafenib Preclinical - Cell culture Actionable In a preclinical study, Ojemda (tovorafenib) inhibited downstream signaling and proliferation of several BRAF mutant solid tumor cell lines in culture (EJC Supp, Nov 2010, Vol 8(7), p40-41). detail...
BRAF L485_P490delinsFS Advanced Solid Tumor predicted - sensitive Tovorafenib Preclinical - Biochemical Actionable In a preclinical study, Ojemda (tovorafenib) inhibited Mek and Erk phosphorylation in cells expressing BRAF L485_P490delinsFS in culture (PMID: 37656784). 37656784
BRAF G469A lung adenocarcinoma resistant Tovorafenib Preclinical - Patient cell culture Actionable In a preclinical study, cells derived from a lung adenocarcinoma patient harboring BRAF G469A were resistant to treatment with Ojemda (tovorafenib) in culture (PMID: 32540409). 32540409
BRAF L597V lung adenocarcinoma resistant Tovorafenib Preclinical - Patient cell culture Actionable In a preclinical study, cells derived from a lung adenocarcinoma patient harboring BRAF L597V were resistant to treatment with Ojemda (tovorafenib) in culture (PMID: 32540409). 32540409
BRAF rearrange childhood low-grade glioma sensitive Tovorafenib FDA approved Actionable In a Phase II trial (FIREFLY-1) that supported FDA approval, Ojemda (tovorafenib) was well tolerated and resulted in an overall response rate (ORR) per RAPNO criteria of 51% (39/76, 28 partial and 11 minor responses), clinical benefit rate (CBR) of 82% (62/76), and median duration of response of 13.8 mo in pediatric patients with low-grade glioma harboring BRAF fusions, rearrangements, or BRAF V600 mutations, with an ORR of 52% (33/64) in patients harboring BRAF fusions (PMID: 37978284; NCT04775485). detail... 37978284
BRAF V600E melanoma sensitive Tovorafenib Preclinical - Cell culture Actionable In a preclinical study, Ojemda (tovorafenib) treatment inhibited viability of a melanoma cell line harboring BRAF V600E in culture (PMID: 31618628). 31618628
BRAF V600X childhood low-grade glioma sensitive Tovorafenib FDA approved Actionable In a Phase II trial (FIREFLY-1) that supported FDA approval, Ojemda (tovorafenib) was well tolerated and resulted in an overall response rate (ORR) per RAPNO criteria of 51% (39/76, 28 partial and 11 minor responses), clinical benefit rate (CBR) of 82% (62/76), and median duration of response of 13.8 mo in pediatric patients with low-grade glioma harboring BRAF fusions, rearrangements, or BRAF V600 mutations, with an ORR of 50% (6/12) in patients harboring BRAF V600E (PMID: 37978284; NCT04775485). detail... 37978284
BRAF mutant colorectal cancer sensitive Tovorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, Ojemda (tovorafenib) demonstrated efficacy in BRAF mutant xenograft models of melanoma and colorectal cancer (J Clin Oncol 31, 2013 (suppl; abstr e13529)). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05566795 Phase III Tovorafenib DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) Recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13
NCT04775485 Phase II Tovorafenib A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors (FIREFLY-1) Recruiting USA | NLD | GBR | DEU | CAN | AUS 5
NCT05465174 Phase II Nivolumab + Tovorafenib Tovorafenib Nivolumab Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults (PNOC029) Recruiting USA 0
NCT03429803 Phase I Tovorafenib DAY101 In Gliomas and Other Tumors Active, not recruiting USA 0
NCT06381570 Phase I Tovorafenib + Vinblastine Tovorafenib Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas (VICTORY) Recruiting CAN 0
NCT01425008 Phase I Tovorafenib Study of MLN2480 in Patients With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Patients With Metastatic Melanoma Completed USA | GBR 0
NCT04985604 Phase Ib/II Pimasertib + Tovorafenib Tovorafenib Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors Recruiting USA | FRA | ESP | CAN | BEL | AUS 1


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