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LY3022855

Phase 1

Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Oct 16, 2023

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02718911A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid TumorsPHASE1 COMPLETED 72 — — Jun 16, 2016Dec 14, 2018Oct 16, 202314 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Recommended Phase 2 Dose of LY3022855 Combined With Durvalumab (Maximum Tolerated Dose [MTD])
Cycle 1 (4 weeks)

Recommended Phase 2 dose of LY3022855 that could be safely administered in combination with Durvalumab was based on defined dose limiting toxicities (DLT) assessment and MTD definition. MTD is defined as the highest tested dose that has less than 33% probability of causing a DLT.

Secondary Endpoints
Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Baseline through Measured Progressive Disease or Death (Up To 24 months)
Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]
Baseline through Measured Progressive Disease (Up To 24 months)
Number of Participants With Anti-LY3022855, Anti-Durvalumab or Anti-Tremelimumab Antibodies
Baseline through Follow-up (Up To 24 Months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3022855 + Durvalumab (Dose Escalation)EXPERIMENTALCohort D1A: LY3022855 (25 mg,QW)+Durvalumab (750mg,Q2W): 25 mg LY3022855 administered once weekly (QW) intravenously (IV) in combination with 750 mg durvalumab administered every 2 weeks (Q2W) IV. Treatment may continue until disease progression or discontinuation. Cohort D2A: LY3022855 (50 mg,QW)+Durvalumab (750mg,Q2W) 50 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. Cohort D3A: LY3022855 (75 mg,QW)+Durvalumab (750mg,Q2W) 75 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. Cohort D4A: LY3022855 (100 mg,QW)+Durvalumab (750mg,Q2W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
LY3022855 + Tremelimumab (Dose Escalation)EXPERIMENTALCohort T1A: LY3022855 (50 mg,QW) +Tremelimumab (75mg,Q4W): 50 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered every 4 weeks (Q4W) IV. Treatment may continue until disease progression or discontinuation. Cohort T2A: LY3022855 (100 mg,QW) +Tremelimumab (75mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 75 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. Cohort T3A: LY3022855 (100 mg,QW) +Tremelimumab (225 mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 225 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation. Cohort T4A: LY3022855 (100 mg,QW) +Tremelimumab (750 mg,Q4W) 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg tremelimumab administered Q4W IV. Treatment may continue until disease progression or discontinuation.
LY3022855 + Durvalumab (Expansion)EXPERIMENTALCohort B-1: NSCLC LY3022855+ Durvalumab: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation. Cohort B-1: OVARIAN LY3022855+ Durvalumab: 100 mg LY3022855 administered QW intravenously (IV) in combination with 750 mg durvalumab administered Q2W IV. Treatment may continue until disease progression or discontinuation.
Interventions
NameTypeDescription
LY3022855DRUGAdministered IV
DurvalumabDRUGAdministered IV
TremelimumabDRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Must have histological or cytological evidence of a diagnosis of cancer that is not amenable to curative therapy. * Part B: Must have a type of malignancy that is being studied. * Part A and Part B (ovarian cancer cohort only): Must be willing to undergo pretreatment and on-tr...

Countries:United StatesBelgiumCzechiaIsrael
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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