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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) 29	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 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 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 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	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
NRAS G12D	acral lentiginous melanoma	predicted - sensitive	Tovorafenib	Case Reports/Case Series	Actionable	In a clinical case study, Ojemda (tovorafenib) treatment resulted in a partial response with therapy lasting at least 7.5 years in a patient with metastatic acral melanoma harboring NRAS G12D (PMID: 39001563).	39001563
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...
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 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 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 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 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

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT03429803	Phase I	Tovorafenib	DAY101 In Gliomas and Other Tumors	Active, not recruiting	USA	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	Active, not recruiting	USA \| FRA \| ESP \| CAN \| BEL \| AUS	1
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
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 \| ISR \| GBR \| DNK \| DEU \| CHE \| CAN \| AUS	2
NCT05465174	Phase II	Nivolumab + Tovorafenib Tovorafenib Nivolumab	Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults (PNOC029)	Recruiting	USA	0
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 \| SWE \| SVN \| NZL \| NOR \| NLD \| ITA \| ISR \| IRL \| HUN \| GRC \| GBR \| FRA \| FIN \| ESP \| DNK \| DEU \| CZE \| CHE \| CAN \| BRA \| BEL \| AUT \| AUS	4

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