LBA02-11 MASITINIB PLUS DOCETAXEL AS FIRST-LINE TREATMENT OF METASTATIC CASTRATE REFRACTORY PROSTATE CANCER: RESULTS FROM STUDY AB12003

You have accessJournal of UrologyLate-breaking Abstract II - Malignant1 Sep 2021LBA02-11 MASITINIB PLUS DOCETAXEL AS FIRST-LINE TREATMENT OF METASTATIC CASTRATE REFRACTORY PROSTATE CANCER: RESULTS FROM STUDY AB12003 Michel Pavic, Olivier Hermine, and Dominique Spaeth PavicMichel Pavic More articles by this author , HermineOlivier Hermine SpaethDominique View All Author Informationhttps://doi.org/10.1097/JU.0000000000002149.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail INTRODUCTION AND OBJECTIVE: Masitinib (MAS) is an oral, small molecule drug that targets mast cell macrophage activity. These innate immune cells are critical components the tumor microenvironment associated with prostate cancer progression. METHODS: was a prospective, placebo (PBO) controlled, double blind, randomized, phase 3 trial, evaluating MAS (6.0 mg/kg/d) in combination docetaxel (DTX) (IV 75 mg/m2 plus prednisone for up 10 cycles) as first-line treatment metastatic castrate resistant (mCRPC). Eligible patients (pts) were chemo-naïve confirmed mCRPC, who had progressed on previous abiraterone or indicated DTX treatment, ECOG ≤1. Primary analysis performed pre-specified targeted subgroup, defined pts baseline alkaline phosphatase levels (ALP) ≤250 IU/ml, overall population. endpoint progression free survival (PFS) (PCWG2 definition). The study successful if improvement median PFS relative control reached 3.9% level significance target subgroup (alpha split fallback procedure conserve type-I error at 5% cohort). RESULTS: A total 714 enrolled (safety population n=712). In (ALP ≤250) MAS-DTX (n=225) showed significant benefit over PBO-DTX 6.3 months (96.1% CI [5.6;7.6]) vs 5.4[4.6;6.0] months; p=0.0272. hazard ratio (HR) 0.79 [0.64;0.97], p=0.0087), 21% reduction risk control. Assessment rates convergent primary outcome; 12, 18, 24-month 1.6-fold (p=0.0035), 1.9-fold (p=0.0001) (p=0.0028) improvement, respectively, favor (ie, 32.0%, 27.6% 23.1% 19.6%, 14.6% 12.0% PBO-DTX). There no (OS) subgroup. Regarding irrespective ALP), OS observed; (n=355) 5.7 (95% [4.9;6.3]) 5.4[4.6;5.9] (n=357), p=0.2977. proportion presenting least one adverse event (AE), severe AE serious 96.6%, 79.2% 96.4%, 73.1% 18.8% (n=357). CONCLUSIONS: may provide new option mCRPC ALP IU/ml. Source Funding: AB Science, France © 2021 American Urological Association Education Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1179-e1179 Advertisement Copyright & Permissions© Inc.MetricsAuthor Information Expand Loading ...