Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as valemetostat tosylate
valemetostat · 1 trial · 2 indications
Total number of participants with A Dose-Limiting Toxicity (DLT) at each dose level of valemetostat in combination with pembrolizumab per National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0.
Incidence of TEAEs, Grade 3 or 4 TEAEs, deaths, TESAEs, TEAEs leading to dose modifications (including interruption, reduction, and discontinuation), and AESIs using the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0
PFS is the time from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) per RECIST v1.1 or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Phase 1b: Pembrolizumab + Valemetostat Tosylate | EXPERIMENTAL | Participants will be provided with pembrolizumab at standard dose of 200 mg intravenously (IV) Q3W, and valemetostat will be provided per a dose escalation schedule, with an initial starting dose of 150 mg by mouth once daily. |
| Phase 2: Pembrolizumab + Valemetostat Tosylate | EXPERIMENTAL | Participants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W, and valemetostat will be provided per recommended phase 2 dose (RP2D) |
| Phase 2: Pembrolizumab | ACTIVE_COMPARATOR | Participants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W |
| Name | Type | Description |
|---|---|---|
| valemetostat tosylate | DRUG | Valemetostat will be administered orally once daily until RP2D of valemetostat is determined. |
| pembrolizumab | DRUG | One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles. |
Key Inclusion Criteria: 1. Has signed and dated the ICF, prior to the start of any trial-specific qualification procedures. 2. Is an adult ≥18 years of age or the minimum legal age (whichever is greater) at the time of informed consent. (Follow local regulatory requirements if the legal age of adul...
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Valemetostat is an investigational small molecule being studied for the treatment of non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development as a combination therapy with pembrolizumab for first-line NSCLC without actionable genomic alterations.
Valemetostat is a -stat class enzyme inhibitor, meaning it works by inhibiting a specific enzyme. In the context of its clinical trial, it is being evaluated in combination with pembrolizumab for the treatment of non-small cell lung cancer.
Valemetostat is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.
Valemetostat is in Phase 1 clinical development. It is currently being studied in an active, not recruiting clinical trial for non-small cell lung cancer, and it is not yet approved by regulatory authorities.
Valemetostat is being studied in one active Phase 1 clinical trial, NCT06644768, which evaluates valemetostat tosylate plus pembrolizumab versus pembrolizumab alone in first-line non-small cell lung cancer without actionable genomic alterations. The trial has an enrollment of 137 participants.
Yes, valemetostat and valemetostat tosylate refer to the same drug. Valemetostat tosylate is the salt form of valemetostat, and the clinical trial NCT06644768 specifically studies valemetostat tosylate in combination with pembrolizumab.