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Filanesib, KSP inhibitor

Phase 2

Advanced Multiple Myeloma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 19, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment231

FDA Designations

No designations recorded

Clinical trial landscape

Filanesib, KSP inhibitor · 2 trials · 1 indication

Phase 2 2
NCT02092922A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)Advanced Multiple Myeloma
COMPLETED154 Analytics
NCT01989325A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple MyelomaAdvanced Multiple Myeloma
COMPLETED77 Analytics
PHASE2COMPLETED
A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
Advanced Multiple MyelomaUnlock trial analytics
PHASE2COMPLETED
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
Advanced Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.
up to 2 years
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
18 months

Secondary Endpoints

In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.
up to 2 years
In all patients, assess the efficacy of the study drug in terms of duration of response.
up to 2 years
In all patients, assess the efficacy of the study drug in terms of progression-free survival.
up to 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FilanesibEXPERIMENTAL -
Carfilzomib + FilanesibEXPERIMENTALSingle agent + Carfilzomib arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information. Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
CarfilzomibEXPERIMENTALSingle agent arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.

Interventions

NameTypeDescription
Filanesib, KSP (Eg5) inhibitor; intravenousDRUGmultiple dose, single schedule
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDRUGstandard of care
Carfilzomib, proteasome inhibitor; intravenousDRUGmultiple dose, single schedule
Filanesib, KSP(Eg5) inhibitor; intravenousDRUGmultiple dose, single schedule
Dexamethasone, steroid; oral or intravenousDRUGas indicated, per the carfilzomib prescribing information
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites60

Key Inclusion Criteria: * Patients with confirmed multiple myeloma whose treatment history must include all of the following: 1. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy). 2. Received at l...

Countries:United StatesBelgiumCanadaFranceGermanyGreeceSpainUnited Kingdom
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Advanced Multiple Myeloma")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about Filanesib, KSP inhibitor

What is Filanesib used for?

Filanesib is an investigational small molecule being studied for the treatment of advanced multiple myeloma. It is a kinesin spindle protein (KSP) inhibitor, which means it targets a protein involved in cell division. Filanesib is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Filanesib target?

Filanesib targets kinesin spindle protein (KSP), a protein essential for cell division. By inhibiting KSP, Filanesib is designed to disrupt the division of cancer cells, potentially slowing or stopping tumor growth. This mechanism is being evaluated in clinical trials for advanced multiple myeloma.

Who is developing Filanesib?

Filanesib is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for advanced multiple myeloma, and it remains an investigational agent.

What phase is Filanesib in?

Filanesib is in Phase 2 clinical development. It has completed two Phase 2 trials for advanced multiple myeloma, with a total enrollment of 231 patients. Filanesib is not FDA approved and remains an investigational drug under study.

What clinical trials is Filanesib in?

Filanesib has completed two Phase 2 clinical trials. The first, NCT01989325, studied Filanesib in combination with carfilzomib in 77 patients with advanced multiple myeloma in the United States. The second, NCT02092922, known as the AfFIRM trial, enrolled 154 patients with relapsed or refractory multiple myeloma across multiple countries.

Is Filanesib the same as ARRY-520?

Yes, Filanesib is also known as ARRY-520. In clinical trials, the drug has been referred to by both names. For example, the study NCT01989325 is titled 'A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma,' confirming that Filanesib and ARRY-520 refer to the same investigational drug.