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MET/VEGFR2 inhibitor Foretinib

Phase 1

Lung Cancer | Small molecule | Oncology |GSK plc|Last Updated: Aug 4, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01068587MET/VEGFR2 Inhibitor GSK1363089 and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone in Locally Advanced or Metastatic NSCLC That Has Not Responded to Previous ChemotherapyPHASE1 COMPLETED 31Jan 21, 2010Feb 13, 2015Aug 4, 20234 Canada
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Study Endpoints
Primary Endpoints
The recommended phase II dose of daily oral MET/VEGFR2 inhibitor Foretinib when given in combination with standard erlotinib hydrochloride therapy (phase I)
3 years

After completion of Phase I portion of the study

Safety, tolerability, dose-limiting toxicities, and pharmacokinetic profile (phase I)
3 years

Assessed from the time of first dose. Results will be analyzed at time of final analysis

Correlation between toxicity and pharmacokinetics (phase I)
3 years

After completion of phase I

Objective tumor response rate (partial or complete response) (phase II)
After every second cycle
Secondary Endpoints
Clinical benefit (complete response, partial response, and stable disease for ≥ 8 weeks) (phase II)
8 weeks
Tumor size at 8 weeks (phase II)
8 weeks
1-year survival rate (phase II)
1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ErlotinibACTIVE_COMPARATOR -
Foretinib plus ErlotinibACTIVE_COMPARATOR -
Interventions
NameTypeDescription
MET/VEGFR2 inhibitor ForetinibDRUGPhaseI and Phase II Arm A: Foretinib PO daily dosing starting cycle 1 day 15 and erlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I.
erlotinib hydrochlorideDRUGerlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I.
laboratory biomarker analysisOTHERTumour markers alone cannot be used to assess objective tumour response. If markers are initially above the upper normal limit, however, they must normalize for a patient to be considered in complete response
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting all of the following criteria: * Locally advanced or metastatic disease * Failed 1-2 prior chemotherapy regimen * Must be eligible to receive erlotinib therapy (i.e., patients ...

Countries:Canada
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Competitive Landscape -Lung Cancer 290 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK10PHASE3Pembrolizumab, Olaparib, Etoposide /m^2, Pembrolizumab/Vibostolimab Co-Formulation, Etoposide
Gilead Sciences, Inc.GILD5PHASE3Sacituzumab Govitecan, Topotecan, Amrubicin, Lurbinectedin, Domvanalimab
Amgen Inc.AMGN14PHASE3Tarlatamab, Durvalumab, ABP 234, Pembrolizumab, Lurbinectedin
AstraZeneca PLCAZN32PHASE3Durvalumab, Tremelimumab, Volrustomig, Pembrolizumab, Carboplatin
BioNTech SE Sponsored ADRBNTX6PHASE3Pumitamig, Atezolizumab, Etoposide, Carboplatin, PM8002
Bristol-Myers Squibb CompanyBMY15PHASE3MRTX849, Docetaxel, BMS-986489, Atezolizumab, Carboplatin
Pfizer Inc.PFE13PHASE3PF-08634404, Pembrolizumab, Chemotherapy Regimen 1, PF-07220060, Letrozole
AbbVie, Inc.ABBV4PHASE3ABBV-706, Topotecan, Lurbinectedin, Amrubicin, Telisotuzumab Adizutecan
ArriVent BioPharma, Inc.AVBP6PHASE3furmonertinib , daily, platinum-based chemotherapy, Firmonertinib, JAB-21822, Tislelizumab
Eli Lilly and CompanyLLY3PHASE3Ramucirumab, Erlotinib, Gefitinib, Osimertinib, LY4175408
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Atezolizumab, Lurbinectedin, Carboplatin, Etoposide, Durvalumab
Summit Therapeutics IncSMMT1PHASE3AK112
Revolution Medicines, Inc.RVMD2PHASE3daraxonrasib, docetaxel, RMC-6291, RMC-6236, Pembrolizumab
Incyte CorporationINCY3PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3TAK-788, Pemetrexed, Cisplatin, Carboplatin
Regeneron Pharmaceuticals, Inc.REGN5PHASE2BNT116, Cemiplimab, Fianlimab, Pemetrexed, Paclitaxel
ImmunityBio IncIBRX3PHASE3Drug: Nogapendekin alfa inbakicept, Pembrolizumab, Cisplatin or Carboplatin, Nab-paclitaxel OR Pemetrexed, Nab-paclitaxel OR Paclitaxel OR Docetaxel
Immutep Ltd Sponsored ADRIMMP2PHASE3eftilagimod alfa, carboplatin plus paclitaxel, cisplatin or carboplatin + pemetrexed, pembrolizumab, IMP321
GSK plc Sponsored ADRGSK1PHASE3Ris-Rez, Topotecan
Zai Lab Ltd. Sponsored ADRZLAB2PHASE3ZL-1310, Atezolizumab, Carboplatin
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