Therapy Detail

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Therapy Name Tovorafenib
Synonyms
Therapy Description

MLN2480 (TAK-580) is an inhibitor of pan-Raf kinases, which interrupts RAF/MEK/ERK signal transduction pathways to inhibit tumor cell growth (PMID: 28082416, PMID: 30622172).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Tovorafenib BIIB-024|TAK-580|MLN-2480|TAK580|DAY101|MLN2480 RAF Inhibitor (Pan) 27 Tovorafenib (MLN2480) is an inhibitor of pan-Raf kinases, which interrupts RAF/MEK/ERK signal transduction pathways to inhibit tumor cell growth (PMID: 28082416, PMID: 30622172).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF mutant Advanced Solid Tumor predicted - sensitive Tovorafenib Preclinical - Cell culture Actionable In a preclinical study, Tovorafenib (MLN2480) 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 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 Tovorafenib (MLN2480) in culture (PMID: 32540409). 32540409
BRAF fusion low grade glioma predicted - sensitive Tovorafenib Phase II Actionable In a Phase II trial (FIREFLY-1), Tovorafenib (MLN2480) treatment was well-tolerated and resulted in an overall response rate of 64% (44/69, 3 complete responses, 41 partial responses (10 unconfirmed)) and a clinical benefit rate of 91% in pediatric patients with low-grade glioma harboring BRAF fusions (n=64) or BRAF V600E (n=13) (J Clin Oncol 41, 2023 (suppl 16; abstr 10004); NCT04775485). detail...
BRAF mutant melanoma sensitive Tovorafenib Phase I Actionable In a Phase I trial, Tovorafenib (MLN2480) 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, Tovorafenib (MLN2480) demonstrated efficacy in BRAF mutant xenograft models of melanoma and colorectal cancer (J Clin Oncol 31, 2013 (suppl; abstr e13529)). detail...
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 Tovorafenib (MLN2480) in culture (PMID: 32540409). 32540409
BRAF mutant colorectal cancer sensitive Tovorafenib Preclinical - Cell line xenograft Actionable In a preclinical study, Tovorafenib (MLN2480) demonstrated efficacy in BRAF mutant xenograft models of melanoma and colorectal cancer (J Clin Oncol 31, 2013 (suppl; abstr e13529)). detail...
BRAF V600E low grade glioma predicted - sensitive Tovorafenib Phase II Actionable In a Phase II trial (FIREFLY-1), Tovorafenib (MLN2480) treatment was well-tolerated and resulted in an overall response rate of 64% (44/69, 3 complete responses, 41 partial responses (10 unconfirmed)) and a clinical benefit rate of 91% in pediatric patients with low-grade glioma harboring BRAF fusions (n=64) or BRAF V600E (n=13) (J Clin Oncol 41, 2023 (suppl 16; abstr 10004); NCT04775485). detail...

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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
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 | GBR | DEU | CAN | AUS 6
NCT05465174 Phase II Nivolumab + Tovorafenib Tovorafenib Nivolumab Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults (PNOC029) Recruiting USA 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
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 | ESP | DEU | CAN | AUS 11


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