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.
Rattachement africain : jp, es, us, cn. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
e17043 Background: M is a potent and selective inhibitor of enhancer of zeste homolog 2. M 1250 mg twice daily (BID) on an empty stomach + E + androgen deprivation therapy showed improved outcomes vs E alone in pts with mCRPC, with a manageable adverse event (AE) profile, in the randomized, dose-expansion part of a phase 1 study (NCT03460977). We report efficacy and safety data from two pt cohorts (2A and 2C) who received M 875 mg BID with food + E. Methods: 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. Primary endpoints were radiographic progression-free survival (rPFS) per investigator assessment and safety. Secondary endpoints included objective response (OR) by RECIST 1.1 (for pts with measurable disease at baseline) and decline in prostate-specific antigen of ≥50% from baseline (PSA 50 ). Results: As of September 1, 2025, 29 pts had received M 875 mg BID with food + E (2A, n = 15; 2C, n = 14). Median (range) age was 74 (61–86) years in 2A and 73 (55–83) years in 2C. In 2A, 9 pts (60.0%) had received abiraterone and 9 pts (60%) had received E; in 2C, 14 pts (100%) received prior abiraterone and were E naive. Efficacy and safety outcomes for 2A and 2C are shown (Table). Six confirmed events (5 progressive disease,1 death) were observed in 2A and 4 (all progressive disease) in 2C; median (90% confidence interval [CI]) rPFS was 14.3 (2.0, not estimable [NE]) months in 2A and NE (6.2, NE) months in 2C. Confirmed PSA 50 was observed in 6 pts (40.0%; 95% CI 16.3, 67.7) in 2A and 6 pts (42.9%; 95% CI 17.7, 71.1) in 2C. In pts with measurable disease at baseline (2A, n = 4; 2C, n = 6), confirmed OR rate (95% CI) was 25.0% (0.6, 80.6; 1 partial response) in 2A and 16.7% (0.4, 64.1; 1 partial response) in 2C. For 2A+2C combined, most common treatment-emergent AEs (TEAEs) were diarrhea (48.3%), thrombocytopenia (48.3%), and decreased appetite (44.8%). Grade ≥3 TEAEs were observed in 41.3% pts (most common: thrombocytopenia, anemia, asthenic conditions, and hypokalemia). Grade ≥3 TEAEs considered related to M were reported in 31.0% pts. There were no treatment-related deaths. Conclusions: 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 trial information: NCT03460977 . 2A(n=15) 2C(n=14) 2A + 2C(n=29) Efficacy Median rPFS (90% CI), months 14.3 (2.0, NE) NE (6.2, NE) – OR (95% CI), % 25.0 (0.6, 80.6) 16.7 (0.4, 64.1) – PSA 50 (95% CI), % 40.0 (16.3, 67.7) 42.9 (17.7, 71.1) – Safety, n (%) Any TEAE 15 (100) 14 (100) 29 (100) Grade ≥3 6 (40.0) 6 (42.9) 12 (41.4) TEAE related to M 15 (100) 13 (92.9) 28 (96.6) Grade ≥3 4 (26.7) 5 (35.7) 9 (31.0)
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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.
- Date Crossref
- 01/06/2026
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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National Cancer Center Hospital East, Medical Oncology Department — Hospital Universitario Ramón y Cajal et Hospital Universitario Fundación Jiménez Díaz, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.