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Talimogene Laherparepvec

Phase 2

Sarcoma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Oct 29, 2025

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
NCT03069378A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced SarcomaPHASE2 ACTIVE NOT_RECRUITING 41Mar 3, 2017Mar 1, 2026Oct 29, 20255 United States
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Study Endpoints
Primary Endpoints
Best Objective Response Rate
24 weeks

(complete response + partial response) RECIST 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Talimogene Laherparepvec (T-VEC) Administered with PembrolizuEXPERIMENTALPatients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Interventions
NameTypeDescription
Talimogene Laherparepvec (T-VEC)DRUGTalimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
PembrolizumabDRUGPembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male or female age ≥ 18 years at the time of informed consent * Be willing and able to provide written informed consent/assent for the trial * Be willing to comply with treatment protocol * Subjects must have a histologically confirmed metastatic and/or locally advanced inoper...

Countries:United States
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