Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral [14C] PF-06821497, Mevrometostat (PF-06821497), Mevrometostat
PF-06821497 · 4 trials · 9 indications
rPFS is defined as the time from randomization until PD based on BICR assessment per RECIST v1.1 (soft tissue disease) and PCWG3 (bone disease), or death due to any cause, whichever occurs first.
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
First cycle DLTs will be utilized to determine the MTD
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[4.03\])
Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version \[4.03\]), and timing.
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.
PCWG3
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily) |
| Arm B | ACTIVE_COMPARATOR | Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily) |
| Dose Escalation (Part 1A) | EXPERIMENTAL | Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels |
| Dose Escalation (Part 1B) | EXPERIMENTAL | Participants with FL will receive mevrometostat at escalating dose levels |
| Dose Escalation (Part 1C) | EXPERIMENTAL | Participants with mCRPC will receive mevrometostat at escalating dose levels. |
| Dose Escalation (Part 2A) | EXPERIMENTAL | Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC. |
| Dose Expansion (Part 2B) | EXPERIMENTAL | Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone. |
| Japan Cohort | EXPERIMENTAL | Participants with CRPC will receive mevrometostat at one or two doses |
| China cohort | EXPERIMENTAL | Participants will receive mevrometostat at one or two doses |
| Dose Expansion (Part 2C) | EXPERIMENTAL | Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC |
| BE Substudy | EXPERIMENTAL | In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
| DDI Substudy | EXPERIMENTAL | The DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day. |
| Name | Type | Description |
|---|---|---|
| Mevrometostat | DRUG | Oral continuous |
| Placebo | DRUG | Oral continuous |
| Enzalutamide | DRUG | Oral continuous |
| PF-06821497 | DRUG | Oral continuous |
| Docetaxel | DRUG | 75 mg/m2 IV (every 21 days) |
| Mevrometostat (PF-06821497) | DRUG | Oral continuous |
| Itraconazole | DRUG | Oral solution |
Inclusion Criteria * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic prostate cancer documented by positive bone s...
Mevrometostat is an investigational oral medicine being studied for prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It is also being evaluated in small cell lung cancer and follicular lymphoma. It is not yet approved for any indication and remains in clinical development.
Mevrometostat is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is running the clinical program for the drug across prostate cancer and other tumor types.
Mevrometostat is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting participants, and one additional Phase 3 trial is active but no longer recruiting. An earlier Phase 1 study is also still recruiting. The drug is investigational and has not been approved by the FDA.
Mevrometostat is being studied in several trials. NCT07028853 is a Phase 3 trial combining mevrometostat with enzalutamide in mCSPC. NCT06629779 is a Phase 3 trial in mCRPC. NCT06551324 (MEVPRO-1) is a Phase 3 trial in mCRPC previously treated with abiraterone acetate. NCT03460977 is a Phase 1 trial in relapsed or refractory small cell lung cancer, castration-resistant prostate cancer, and follicular lymphoma.
Yes, mevrometostat and PF-06821497 refer to the same investigational drug. The compound is also identified in some study records as oral [14C] PF-06821497, which denotes a radiolabeled version used in clinical research. All of these names refer to the same Pfizer development program.