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panobinostat/LBH589B

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Novartis AG|Last Updated: Dec 19, 2020

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
UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01463046Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic SyndromePHASE1 COMPLETED 29 — — Jan 1, 2012Dec 1, 2018Apr 22, 20191 United States
NCT01055483A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid LeukemiaPHASE1 COMPLETED 59 — — Sep 1, 2009Feb 1, 2012Dec 19, 20206 France, Germany
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Study Endpoints
Primary Endpoints
The maximum tolerated dose (MTD) for the combination of panobinostat with standard-dose cytarabine and daunorubicin (7+3) for untreated AML and advanced MDS in the elderly.
Start of induction therapy until 21 days after the last dose of induction or second induction therapy or until count recovery in patients without residual disease, whichever is longer
The recommended Phase II dose for the combination of panobinostat with standard-dose cytarabine and daunorubicin (7+3) for untreated AML and advanced MDS in the elderly.
Start of induction therapy until 21 days after the last dose of induction or second induction therapy or until count recovery in patients without residual disease, whichever is longer
Incidence of dose limiting toxicity (DLT)
1 cycle (1 cycle = 28 days)
Secondary Endpoints
Response rate (OR, CR, CRi) for AML using Revised Recommendations of the International Working Group
18 days after the start of induction therapy or 37 days after the second induction therapy or when white blood cell count recovers, whichever is first.
Response rate (OR, CR, CRi) for AMS using International Working Group response criteria in myelodysplasia
18 days after the start of induction therapy or 37 days after the second induction therapy or when white blood cell count recovers, whichever is first.
Relapse-free survival
The time to relapse or death from any cause from the date of confirmed morphologic CR.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PanobinostatEXPERIMENTAL -
LBH589EXPERIMENTAL -
Interventions
NameTypeDescription
PanobinostatDRUGInduction - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8 Second induction - 20-60 mg (1-3 20 mg capsules) PO days 1,3 and 5 Consolidation - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8
CytarabineDRUGInduction - 100 mg/m2 continuous IV daily for 7 doses on day 3-9. Second induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-7. Dosing for consolidation - 100 mg/m2 continuous IV daily for 7 doses on day 3-9.
DaunorubicinDRUGInduction - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5. Second induction - 60 mg/m2 IV over 15-30 minutes daily for 2 doses on day 3 and 4. Dosing for consolidation - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5.
panobinostat/LBH589BDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Untreated histologically confirmed acute myeloid leukemia OR advanced myelodysplastic syndrome (INT-2 or High risk) not previously treated with anthracycline-based chemotherapy OR a therapy-related myeloid neoplasm * Male or female aged ≥ 60 years * ECOG performance status 0-2...

Countries:United StatesFranceGermany
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