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MIK665

Phase 1

Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma | Small molecule | Oncology |Novartis AG|Last Updated: Aug 3, 2021

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
UNCONTROLLED
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02992483Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple MyelomaPHASE1 COMPLETED 31 — — Jul 12, 2017Jun 7, 2019Aug 3, 20218 United States, Australia +5
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Study Endpoints
Primary Endpoints
Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.
2 years
Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only
2 years
Tolerability: Dose interruptions
2 years
Tolerability: Dose reductions
2 years
Tolerability: Dose intensity
2 years
Secondary Endpoints
Best Overall response (BOR) per International Myeloma Working Group (IMWG) criteria for Myeloma; and per revised criteria for staging of the International Working Group (IWG) guidelines for Lymphoma
2 years
Area Under Curve (AUC)
2 years
Maximum Plasma Concentration (Cmax)
2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MIK665EXPERIMENTAL -
Interventions
NameTypeDescription
MIK665DRUGMIK665
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria * Age ≥ 18 years. * Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory. * Other Inclusion Criteria May Apply. Exclusion Criteria * Known history of chronic liver disease * History of chronic pancreatitis. * Prior t...

Countries:United StatesAustraliaFranceGermanyItalyJapanSpain
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