Uveal Melanoma Approved Therapies & Global Pipeline


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Last Update: Nov 25, 2022

Approved therapies

CompanyCandidateMoAIndicationApprovals
ImmunocoreKIMMTRAK (Tebentafusp)gp100-HLA-A*02:01-targeted TCR-anti-CD3 scFv bispecificUnresectable/metastatic uveal melanoma in patients who are HLA-A*02:01-positiveJan 2022 (US), Apr 2022 (EU), Jun 2022 (UK, AU, CA)
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Global pipeline

CompanyCandidateMoAIndicationPhase
Aura BiosciencesAU-0111Suprachoroidal injected viral nanoparticle conjugateOcular melanomas (inc. UM)IIb
IDEAYA BiosciencesDarovasertib + Crizotinib2PKC inhibitor + cMET inhibitormUM II
Linnaeus TherapeuticsLNS8801GPER agonistmUM (mono or +pembrolizumab)I/II
Vanquish OncologyPAC-1Procaspase 3 activatormUM (+entrectinib)Ib/II
Verastem OncologyVS-6766 + Defactinib3RAF/MEK clamp + FAK inhibitorGNAQ/11+ mUMII
Merck/SyndaxPembrolizumab + Entinostat4Anti-PD-1 + Class I HDAC inhibitormUMII
Foghorn TherapeuticsFHD-286BRG/BRM1 inhibitormUMI
IDEAYA BiosciencesDarovasertib (IDE196)2PKC inhibitorUM adjuvant therapyI
RocheRO7293583anti-TYRP1/CD3 T cell engagerTYRP1+ melanomasI
ReplimmuneRP25Modified HSV-1 expressing anti-CTLA4mUM (mono or +nivolumab)I
NovartisDYP6886GNAQ/GNA11?mUM, GNAQ/11 mutant melanomasI
NovartisLX1967PKC InhibitormUMI
InxMed (Shanghai)IN10018FAK inhibitor +- Cobimetinib (MEKi)mUMI
Prelude TherapeuticsPRT811PRMT5 inhibitorUM, high grade gliomaI
Hillstream BioPharmaHSB-12168IMCD modulator/ferroptosis inducermUMIND
Kymera TherapeuticsKT-253MDM2 PROTAC degraderAML, lymphomas, UMIND
Discontinued/Failed
BioMed Valley DiscoveriesUlixertinib (BVD-523)9ERK inhibitormUMII
MerckVorinostat10HDAC inhibitormUMII
Array Biopharma/PfizerSotrastaurin + MEK16211PKC inhibitor + MEKimUMIb
Bellicum PharmaceuticalsBPX-70112HLA-A2-PRAME-directed TCR autologous T cellsAML/MDS or UMI
NovartisLX196 + HDM20113PKC inhibitormUMI
1. AU-011: NCT04417530 ph2b pivotal trial ongoing.
2. Darovasertib/Crizotinib combo: Data released 12 Sep 2022. 4/8 cPR in 1L, 11/35 any-line. Tumor shrinkage in 31/35 any-line. Median PFS in 1L not reached. Median PFS ~5 months any-line. Press release. Company planning to initiate registrational trial in 1L mUM in Q1 2023 and trial in neo-adjuvant UM in Q4 2022 as monotherapy.
3. VS-6766 + Defactinib: NCT04720417. Investigator sponsored trial
4. Pembrolizumab+Entinostat. NCT02697630. Investigator-sponsored. Ph2 results published in Nat Comm. Access. ORR: 14%. CBR 28% at 18 weeks. Median OS 13.4 months. 1-year OS 59%. PFS 2.1 months. 66% of pts developed Gr3+ AEs
5. RP2: NCT04336241. Expansion cohort.
6. DYP688. NCT05415072 FIH not yet recruiting
7. LX196: NCT02601378.
8. HSB-1216: Encapsulated nanoparticle formulation of salinomycin . ODD received Feb 16 2022
9. Ulixertinib (BVD-523): "ERK inhibition with ulixertinib (BVD-523) did not demonstrate activity in patients with metastatic uveal melanoma" - ASCO 2020 abstract conclusion
10. Vorinostat: NCT01587352. Terminated. Investigator sponsored (NCI)
11. Sotrastaurin + MEK162: NCT01801358. Terminated for scientific reasons before the initiation of the Phase II
12. BPX-701: NCT02743611.
13. LX196 + HDM201: NCT02601378. Combination part of study terminated due to business reasons. Monotherapy ongoing.

Pipeline list does not include non-targeted treatments in unselected solid tumor trials (in which UM patients may be treated).

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