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) 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 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 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 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 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 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 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 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... |
| 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 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 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT05465174 | Phase II | Nivolumab + Tovorafenib Tovorafenib Nivolumab | Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults (PNOC029) | Recruiting | USA | 0 |
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