Recent Updates
Recently added Catalysts

Tislelizumab

Phase 2

Head and Neck Cancer | Monoclonal antibody | Oncology |China Pharma Holdings, Inc.|Last Updated: Jul 31, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05517330Neoadjuvant Tislelizumab With Afatinib for Resectable Head and Neck Squamous Cell CarcinomaPHASE2 COMPLETED 23Sep 19, 2022Jul 31, 2024Jul 31, 20251 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Major Pathologic Response
Time of surgery

Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.

Secondary Endpoints
Pathologic Complete Response
Time of surgery
Objective Response Rate
Up to 8 weeks
Adverse events
Up to 12 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment CohortEXPERIMENTAL* Tislelizumab administration on days 1 and 22, and afatinib continuous administration from days 1 to 42 * Standard of care surgery
Interventions
NameTypeDescription
TislelizumabBIOLOGICAL200mg IV Q3W
AfatinibDRUG30mg PO QD
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 18 years or above. 2. Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following conditions: * were newly diagnosed and without distant metastasis; * were deemed surgically resectable evaluated by a head and neck surge...

Countries:China
Unlock Eligibility Criteria
Competitive Landscape -Head and Neck Cancer 156 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN9PHASE3Monalizumab, Cetuximab, volrustomig, Volrustomig, Cisplatin
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Remzistotug, Niraparib
Merck & Co., Inc.MRK3PHASE3Pembrolizumab, Cisplatin /m^2, pembrolizumab, Cisplatin, Docetaxel
Johnson & JohnsonJNJ4PHASE3JNJ-90301900, Cetuximab, Amivantamab, Pembrolizumab, Carboplatin
Pfizer Inc.PFE6PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin, Palbociclib
Regeneron Pharmaceuticals, Inc.REGN4PHASE2cemiplimab, Platinum Doublet, fianlimab, fianlimab+cemiplimab, Cemiplimab
PDS Biotechnology Corp.PDSB1PHASE3Combination Treatment of PDS0101 and Pembrolizumab, Pembrolizumab Monotherapy
Exelixis, Inc.EXEL4PHASE2Zanzalintinib, Pembrolizumab, cabozantinib, atezolizumab, Nivolumab
Merus B.V.MRUS4PHASE3Petosemtamab, Pembrolizumab, MCLA-129, Osimertinib, Chemotherapy
Bristol-Myers Squibb CompanyBMY3PHASE2Nivolumab, Relatlimab, Ipilimumab, Intratumoral Ipilimumab, BMS-986340
Bicara Therapeutics Inc.BCAX3PHASE2Ficerafusp alfa, Nivolumab, Pembrolizumab, BCA101
Gilead Sciences, Inc.GILD2PHASE2Domvanalimab, Zimberelimab, Paclitaxel, Carboplatin
Inhibrx Biosciences, Inc.INBX2PHASE2INBRX-106, Pembrolizumab, INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5
Incyte CorporationINCY1PHASE2Retifanlimab, INCAGN02385, INCAGN02390
BioNTech SE Sponsored ADRBNTX1PHASE2BNT113, Pembrolizumab
Coherus Oncology, Inc.CHRS4PHASE2Toripalimab, Carboplatin, Cisplatin, Paclitaxel, Docetaxel
ALX Oncology Holdings, Inc.ALXO3PHASE2evorpacept, pembrolizumab, Cisplatin/Carboplatin; 5FU, ALX2004
ImmunityBio IncIBRX2PHASE2N-803 + Pembrolizumab, PD-L1 t-haNK, Cetuximab, NAI
Summit Therapeutics IncSMMT2PHASE3Ivonescimab /kg, Ligufalimab, Pembrolizumab, Ivonescimab
IO Biotech, Inc.IOBT1PHASE2IO102-IO103, Pembrolizumab KEYTRUDA
Unlock Competitive Intelligence