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Palbociclib

Phase 2

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 29, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment4,200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02693535TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage CancerPHASE2 RECRUITING 4,200Mar 14, 2016Dec 31, 2028May 29, 2026181 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria
Assessed at 16 weeks of treatment

Each cohort includes participants with the same tumor type, genomic variant and study drug. For solid tumors, the Response Evaluation Criteria for Solid Tumors (RECIST) criteria will be used, for non-Hodgkin Lymphoma, the Lugano Criteria will be used, and for multiple myeloma, the International Uniform Response Criteria for Multiple Myeloma will be used.

Secondary Endpoints
Overall survival (OS)
Duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 4 (CDKN2A, CDK4, CDK6)OTHERParticipants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation
Group 5 (CSF1R,PDGFR,VEGFR)OTHERParticipants receive sunitinib - dosage, frequency and duration per label; acceptable genomic matches include CSF1R, PDGFR, VEGFR1/2/3, KIT, FLT-3, RET, FGFR1/2/3, VHL amplifications or mutations
Group 6 (mTOR, TSC)OTHERParticipants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations
Group 8 (ERBB2)OTHERParticipants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Group 9 (BRAF V600E/D/K/R)OTHERParticipants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations
Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)OTHERParticipants receive regorafenib - dosage, frequency and duration per label; acceptable genomic matches include RET, VEGFR1/2/3, KIT, PDGFRβ, RAF-1, BRAF mutations or amplifications
Group 14 (BRCA1/2; ATM)OTHERParticipants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions
Group 16 (MSI-H, high mutational load and others)OTHERParticipants receive nivolumab and ipilimumab - dosage, frequency and duration per label; acceptable genomic matches include MSI high status, high tumor mutational burden, MLH1, MSH2/6, PMS2, EPCAM mutations, specific POLE or POLD1 mutations, BRCA1/2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1/2/3/4/5, PCNA, RPA1/2/3/4, and SSBP1 loss of function mutations
Group 17 (CDKN2A, CDK4, CDK6)OTHERParticipants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation
Group 19 (BRCA1/2, PALB2)OTHERParticipants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations
Group 21 (BRCA1/2, PALB2, ATM, and others)OTHERParticipants receive atezolizumab plus talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic mutations in BRCA1/2, PALB2, ATM, ATR, CHEK2, FANCA, RAD51C, NBN, MLH1, MRE11A, CDK12; positive genomic instability score reported on the Myriad MyChoice CDx test; or Genomic Loss of Heterozygosity (LOH) Score above threshold as reported on a FoundationOne CDx test or another qualifying test for TAPUR with MTB approval
Group 24 (ERBB2)OTHERParticipants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
Group 25OTHERParticipants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation
Group 26 (BRAF V600 E mutation )OTHERParticipants receive Dabrafenib plus Trametinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600 E mutation .
Group 27 (ERBB2 amplification, ERBB2 (HER2) IHC2+ or IHC3+ overexpression)OTHERParticipants receive Fam-trastuzumab deruxtecan-nxki (ENHERTU®) - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification, For NSCLC Only-ERBB2 (HER2) IHC2+ or IHC3+ overexpression without ERBB2 amplification)
Interventions
NameTypeDescription
PalbociclibDRUGdrug
SunitinibDRUGdrug
TemsirolimusDRUGdrug
Trastuzumab and PertuzumabDRUGdrug
Vemurafenib and CobimetinibDRUGdrug
RegorafenibDRUGdrug
OlaparibDRUGdrug
Nivolumab and IpilimumabDRUGdrug
AbemaciclibDRUGdrug
TalazoparibDRUGdrug
Atezolizumab and TalazoparibDRUGdrug
Tucatinib plus Trastuzumab Subcutaneous (SC)DRUGdrug
FutibatinibDRUGdrug
Dabrafenib plus TrametinibDRUGDrug
Fam-Trastuzumab Deruxtecan-Nxki (TDxD)DRUGDrug
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites181

Inclusion Criteria: * 12 years of age or older (\*Restrictions apply. Not all therapies are available for patients \<18) * Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatmen...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT02693535lastUpdatePostDate: changed
LOWMay 29, 2026NCT02693535lastUpdatePostDate: changed
LOWMay 29, 2026NCT02693535lastUpdatePostDate: changed
LOWMay 26, 2026NCT02693535primaryCompletionDate: changed
LOWMay 24, 2026NCT02693535studyFirstPostDate: changed