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S-1

Phase 2

Gastric Cancer | Small molecule | Oncology |Sanofi|Last Updated: Dec 18, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00816543Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal AdenocarcinomaPHASE2 COMPLETED 41Dec 1, 2008May 1, 2012Dec 18, 20121 South Korea
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Study Endpoints
Primary Endpoints
R0 resection rate
At the end of the treatment period
Secondary Endpoints
Physical examination
Every 3 months during the study period
Chest X-Ray
Throughout the study period
Computed Tomography scan of the abdomen
Every 6 months during the study period
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
Interventions
NameTypeDescription
DOCETAXELDRUG50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
S-1DRUG80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.
OXALIPLATINDRUG100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-esophageal adenocarcinoma, that is considered operable. * The bulk of disease must be localized in the stomach, although the gastroesophageal junction may be involved. * Patients with T3 ...

Countries:South Korea
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Competitive Landscape -Gastric Cancer 118 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab+ paclitaxel, Paclitaxel, Docetaxel, Irinotecan
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Merck & Co., Inc.MRK1PHASE3pembrolizumab, cisplatin, 5-FU, leucovorin, levoleucovorin
Amgen Inc.AMGN2PHASE3Bemarituzumab, Nivolumab, Chemotherapy, CAPOX, SOX
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY7PHASE2Pumitamig, Folfox, Capox, Nivolumab, BMS-986340
Pfizer Inc.PFE7PHASE2tucatinib, trastuzumab, oxaliplatin, leucovorin, fluorouracil
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel, LY4337713
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography /Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab, Cabozantinib, Durvalumab, Tremelimumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed /m2, Cisplatin /m2
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab, S095029
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
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