mevrometostat (PF-06821497) / Pfizer - LARVOL DELTA

Safety and efficacy of mevrometostat monotherapy in patients (pts) with metastatic castration‑resistant prostate cancer (mCRPC) (ESMO 2026) - No abstract available

Clinical • Metastases • Monotherapy • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

MEVPRO-3: Phase III trial of mevrometostat plus enzalutamide (versus placebo plus enzalutamide) in metastatic castration-sensitive prostate cancer (mCSPC). (ASCO-GU 2026) - P1, P3 | "Enrollment is ongoing in North America and the Asia-Pacific, and planned in Europe and Latin America. Disclosure: Pfizer's generative AI tool, MAIA, was used in developing this abstract; the authors take full responsibility for the content."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Mevrometostat (PF-06821497) in combination with enzalutamide for androgen receptor pathway inhibitor (ARPI)-naïve patients with metastatic castration-resistant prostate cancer (mCRPC): The phase 3, randomized MEVPRO-2 trial. (ASCO-GU 2025) - P1, P3 | "In a nonrandomized, phase 1 dose-escalation study, objective responses to mevrometostat with enzalutamide were observed in patients with CRPC and prior abiraterone or enzalutamide treatment (NCT03460977; Schweizer MT, et al...Hazard ratios and 95% confidence intervals will be estimated using a Cox proportional hazard model, stratified by prior docetaxel and presence of hepatic metastases. P-values will be provided using a stratified log-rank test. Safety and tolerability will also be assessed."

Clinical • Combination therapy • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • EZH2

Efficacy and safety of mevrometostat (M) in combination with enzalutamide (E) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Data from a phase 1 study. (ASCO 2026) - P1 | "We report efficacy and safety data from two pt cohorts (2A and 2C) who received M 875 mg BID with food + E. Pts with mCRPC who received prior abiraterone and/or E (2A) or prior abiraterone (2C), ≤1 prior chemotherapy in any setting, with evidence of progression per modified Prostate Cancer Working Group 3 criteria were included. M 875 mg BID with food + E shows promising outcomes in pts with mCRPC and a manageable AE profile. Further investigation of M + E in pts with mCRPC is warranted."

Clinical • Combination therapy • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

MEVROMETOSTAT (PF-06821497) IN COMBINATION WITH ENZALUTAMIDE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE: THE PHASE 3, RANDOMIZED MEVPRO-1 STUDY (SUO 2024) - P1 | "Approximately 600 patients will be randomized 1:1 to receive mevrometostat (875mg BD with food) with enzalutamide (160mg QD), or physician's choice of enzalutamide (160mg QD) or docetaxel (75mg/m 2 intravenously every 21d). Stratified log-rank P -values, HRs, and 95% CIs will be estimated using a stratified Cox proportional hazard model, and Kaplan–Meier analysis will summarize time-to-event endpoints. "

Clinical • Combination therapy • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

Mevrometostat (PF-06821497) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with abiraterone acetate: The phase 3, randomized MEVPRO-1 study. (ASCO-GU 2025) - P1, P3 | "Approximately 600 patients will be randomized 1:1 to receive mevrometostat (875mg BD with food) with enzalutamide (160mg QD), or physician's choice of enzalutamide (160mg QD) or docetaxel (75mg/m2 intravenously every 21d). Secondary endpoints include anti-tumor activity, safety, pharmacokinetics, ctDNA, and patient-reported outcomes. Stratified log-rank P-values, HRs, and 95% CIs will be estimated using a stratified Cox proportional hazard model, and Kaplan–Meier analysis will summarize time-to-event endpoints."

Clinical • Combination therapy • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and pharmacokinetics of mevrometostat (M) in combination with enzalutamide (E) in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P1 | "Pts with mCRPC who received prior treatment with abiraterone or E, with evidence of progression per modified Prostate Cancer Working Group 3 criteria were included. In pts with mCRPC treated with M + E, M 875 mg with food had an improved safety profile compared with M 1250 mg on an empty stomach. M 875 mg with food has similar plasma exposures to M 1250 mg on an empty stomach. M 875 mg with food + E was selected as the recommended dose for pivotal phase 3 studies."

Clinical • Combination therapy • Metastases • PK/PD data • Anemia • Castration-Resistant Prostate Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. (ASCO-GU 2025) - P1 | " Pts with mCRPC who received prior abiraterone, ≤1 prior chemotherapy in any setting, with evidence of progression per modified Prostate Cancer Working Group 3 criteria were included. M+E shows improved outcomes vs E in pts with mCRPC, with a manageable AE profile. In M+E combination, M 875 mg with food has similar plasma exposure as M 1250 mg on empty stomach. Further investigation of M+E in pts with mCRPC is warranted."

Clinical • Combination therapy • Late-breaking abstract • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 1 trial of mevrometostat (PF-06821497), a potent and selective inhibitor of enhancer of zeste homolog 2 (EZH2), in castration-resistant prostate cancer (CRPC). (ASCO 2024) - P1 | "Dose exploration of M in combination with enzalutamide (E) plus androgen deprivation therapy showed a manageable safety profile and preliminary evidence of objective response (OR), decline in prostate-specific antigen (PSA) to ≥50% of baseline (PSA50), and peripheral pharmacodynamic (PD) modulation in patients (pts) with CRPC in part 2A of a phase 1/2 study (NCT03460977; Schweizer, ESMO 2022, 488P)... This is an open-label, phase 1/2 study of M (orally, 150-1250 mg twice daily) + E (160 mg daily) in adult pts with CRPC who had received prior abiraterone (A) and/or E and had evidence of cancer progression per Prostate Cancer Working Group 3 (PCWG3) criteria at entry... M+E shows promising activity in both post-A (without E) and post-E (± A) pts with CRPC with evidence of tumor PD modulation and with a manageable AE profile. Further investigation of M+E in pts with CRPC is warranted."

P1 data • Anemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor • AR • TP53

Mevrometostat in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone acetate: The phase 3, randomized MEVPRO-1 study. (ASCO 2025) - P1, P3 | "The optimal treatment sequence for patients with mCRPC who progress after first-line treatment with ARPI is not defined; a second ARPI or docetaxel are options used in real-world settings. Time to event endpoints will be compared between treatment arms using a stratified log-test. HRs and 95% CIs will be estimated using a stratified Cox proportional hazard model, and Kaplan–Meier analysis will summarize time-to-event endpoints."

Clinical • Combination therapy • Metastases • P3 data • Anemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

Mevrometostat in combination with enzalutamide for androgen receptor pathway inhibitor (ARPI)-naïve patients with metastatic castration-resistant prostate cancer (mCRPC): The phase 3, randomized MEVPRO-2 study. (ASCO 2025) - P1, P3 | "In a nonrandomized, phase 1 dose-escalation study, objective responses to mevrometostat with enzalutamide were observed in patients with CRPC and prior abiraterone or enzalutamide treatment (NCT03460977; Schweizer MT, et al...Hazard ratios and 95% confidence intervals will be estimated using a Cox proportional hazard model, stratified by prior docetaxel and presence of hepatic metastases. P-values will be provided using a stratified log-rank test. Safety and tolerability will also be assessed."

Clinical • Combination therapy • Metastases • P3 data • Addiction (Opioid and Alcohol) • Anemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hormone Sensitive Prostate Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor • EZH2

Patient-reported outcomes in a randomised phase I study of mevrometostat (M) plus enzalutamide (E) vs E alone in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (ESMO 2025) - P1 | "Methods Pts with progressive mCRPC who received prior abiraterone and ≤1 prior chemotherapy were randomised 1:1 to M (1250 mg BD [empty stomach]) + E (160 mg QD) or E alone. TTDD was significantly longer with M + E vs E for the FACT-P prostate cancer subscale. These findings are being validated in ongoing phase 3 studies."

Clinical • Metastases • P1 data • Patient reported outcomes • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Pfizer | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Pfizer

Metastases • New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Pfizer | Trial completion date: Nov 2021 ➔ Oct 2023 | Trial primary completion date: Nov 2021 ➔ Oct 2023

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Thoracic Cancer

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Pfizer | Trial completion date: Apr 2022 ➔ Mar 2023 | Trial primary completion date: Apr 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=185 | Recruiting | Sponsor: Pfizer | Trial primary completion date: Jul 2023 ➔ Dec 2024

Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Pfizer | Trial completion date: Sep 2023 ➔ Dec 2023 | Trial primary completion date: Sep 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Thoracic Cancer

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Pfizer | Trial completion date: Oct 2021 ➔ Apr 2022 | Trial primary completion date: Oct 2021 ➔ Apr 2022

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Thoracic Cancer

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Pfizer | Trial completion date: Oct 2023 ➔ Feb 2023 | Trial primary completion date: Oct 2023 ➔ Feb 2023

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Thoracic Cancer

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=267 | Recruiting | Sponsor: Pfizer | Trial completion date: Jan 2025 ➔ Apr 2025 | Trial primary completion date: Jan 2025 ➔ Apr 2025 | N=185 ➔ 267

Enrollment change • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Pfizer | Trial completion date: Apr 2023 ➔ Nov 2022 | Trial primary completion date: Apr 2023 ➔ Nov 2022

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

MEVPRO-2: A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Pfizer | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=185 | Recruiting | Sponsor: Pfizer | Trial completion date: Nov 2024 ➔ Jul 2025 | Trial primary completion date: Nov 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=172 | Not yet recruiting | Sponsor: Pfizer | Trial completion date: Jul 2021 ➔ Oct 2020 | Trial primary completion date: Jul 2021 ➔ Oct 2020

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor