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LXH254

Phase 2

Melanoma | Small molecule | Oncology |Novartis AG|Last Updated: Mar 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment134
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04417621Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic MelanomaPHASE2 ACTIVE NOT_RECRUITING 134Oct 30, 2020Feb 2, 2027Mar 12, 202636 United States, Argentina +10
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Study Endpoints
Primary Endpoints
Overall Response Rate
35 months

Confirmed ORR using RECIST v1.1, per local assessment

Secondary Endpoints
Duration of Reposnse (DOR)
4 years
Progression Free Survival (PFS)
4 years
Disease Control Rate (DCR)
3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LXH254 + LTT462EXPERIMENTAL -
LXH254 + trametinibEXPERIMENTAL -
LXH254 + ribociclibEXPERIMENTAL -
Interventions
NameTypeDescription
LXH254DRUGLXH254 will be supplied as tablet for oral use.
LTT462DRUGLTT462 will be supplied as hard gelatin capsule for oral use.
TrametinibDRUGTrametinib will be supplied as film-coated tablet for oral use
RibociclibDRUGRibociclib will be supplied in tablets and hard gelatin capsules.
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Eligibility Criteria
Age Range12 Years — 120 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight \> 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma Previously treated for unresectable or metastatic melanoma: * Participants with NRAS mutation: * Participants must h...

Countries:United StatesArgentinaAustraliaBelgiumFranceGermanyIsraelItalyNetherlandsNorwaySwitzerlandUnited Kingdom
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Competitive Landscape -Melanoma 127 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Intismeran autogene, Pembrolizumab, pembrolizumab, Pembrolizumab Berahyaluronidase alfa
Bristol-Myers Squibb CompanyBMY7PHASE3Nivolumab, Nivolumab + Relatlimab, rHuPH20, Relatlimab, relatlimab+nivolumab
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Fianlimab, Cemiplimab, Pembrolizumab, fianlimab, cemiplimab
Pfizer Inc.PFE4PHASE3Encorafenib, Binimetinib, Pembrolizumab, PF-08046049, PF-07799933
IDEAYA Biosciences, Inc.IDYA4PHASE3Darovasertib, IDE196, Crizotinib, Pembrolizumab, Ipilimumab
Iovance Biotherapeutics IncIOVA6PHASE3Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period, Lifileucel, LN-145/LN-144, Cyclophosphamide
Replimune Group, Inc.REPL5PHASE3Vusolimogene Oderparepvec, Nivolumab, Pembrolizumab, Single-agent chemotherapy, RP1
Amgen Inc.AMGN1PHASE3ABP 206, Nivolumab
Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 ShIMCR3PHASE3Tebentafusp, Brenetafusp, Nivolumab
Immatics N.V.IMTX2PHASE3IMA203, nivolumab plus relatlimab, lifileucel, pembrolizumab, ipilimumab
Aura Biosciences IncAURA4PHASE3Bel-sar
Novartis AG Sponsored ADRNVS6PHASE2LXH254, LTT462, Trametinib, Ribociclib, DYP688
IO Biotech, Inc.IOBT2PHASE3IO102-IO103, Pembrolizumab, Pembrolizumab KEYTRUDA
Erasca, Inc.ERAS1PHASE3Naporafenib, Dacarbazine, Temozolomide, Trametinib
AstraZeneca PLCAZN3PHASE2Ceralasertib, Durvalumab, AZD6750, rilvegostomig, Trastuzumab deruxtecan
Eikon Therapeutics, Inc.EIKN2PHASE2EIK1001, Pembrolizumab, Association atezolizumab + BDB001 + RT
Moderna, Inc.MRNA1PHASE2mRNA-4157, Pembrolizumab
Genmab A/S Sponsored ADRGMAB2PHASE2Acasunlimab, Pembrolizumab, GEN1042, Cisplatin, Carboplatin
Agenus Inc.AGEN1PHASE2Botensilimab, Balstilimab
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04417621primaryCompletionDate: changed
LOWMay 24, 2026NCT04417621studyFirstPostDate: changed