LBA13 Phase III trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (PSMAfore)

医学 紫杉烷 临床终点 中期分析 前列腺癌 内科学 恩扎鲁胺 肿瘤科 无进展生存期 胃肠病学 随机对照试验 泌尿科 癌症 化疗 乳腺癌 雄激素受体
作者
Oliver Sartor,D.E. Castellano Gauna,Ken Herrmann,Johann S. de Bono,Neal D. Shore,K.N. Chi,M. J. Crosby,J.M. Piulats Rodriguez,Aude Fléchon,X.X. Wei,Hakim Mahammedi,Guilhem Roubaud,H. ova,Samson Ghebremariam,Euloge Kpamegan,Teri Kreisl,Neda Delgoshaie,Katja Lehnhoff,Michael J. Morris,Karim Fizazi
出处
期刊:Annals of Oncology [Elsevier]
卷期号:34: S1324-S1325 被引量:41
标识
DOI:10.1016/j.annonc.2023.10.085
摘要

[177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolongs rPFS and OS in patients (pts) with mCRPC and prior ARPI and taxane therapy. PSMAfore (NCT04689828) examined 177Lu-PSMA-617 in taxane-naive pts. Eligible adults had mCRPC, were candidates for ARPI change after one progression on prior ARPI, and had ≥1 PSMA+ and no exclusionary PSMA– lesions by [68Ga]Ga-PSMA-11 PET/CT. Candidates for PARP inhibition and pts with prior systemic radiotherapy (<6 months ago), immunotherapy (except sipuleucel-T), or chemotherapy (except [neo]adjuvant >12 months ago) were ineligible. Randomization was 1:1 to open-label 177Lu-PSMA-617 (7.4 GBq q6w; 6 cycles) or ARPI change (abiraterone/enzalutamide). Pts randomized to ARPI could crossover to 177Lu-PSMA-617 following centrally reviewed radiographic progression (rPD). Endpoints included: rPFS (PCWG3/RECIST v1.1; primary), OS (key secondary) (both overall α=0.025, one-sided), FACT-P (secondary) and ORR/DOR (exploratory). Primary analysis was to occur at ∼156 rPFS events and second OS interim analysis (IA) at ∼125 deaths. Crossover-adjusted analysis was the prespecified method for OS by rank-preserving structural failure time (RPSFT). 468 pts were randomized. At primary analysis (median follow-up, 7.3 months; N = 467), the primary endpoint of rPFS was met (HR, 0.41; 95% CI: 0.29, 0.56; p<0.0001); this was similar at second IA (table). At second IA (45.1% of target deaths), 123/146 (84.2%) pts with rPD who discontinued ARPI crossed over; there was a positive OS trend in favour of 177Lu-PSMA-617 per RPFST but not per unadjusted OS analysis. FACT-P and ORR/DOR favoured the 177Lu-PSMA-617 arm (table). For 177Lu-PSMA-617 vs ARPI change, incidence of grade ≥3 AEs was 34% (most common: anaemia, dry mouth) vs 44%, serious AEs 20% vs 28%, and AEs leading to discontinuation 5.7% vs 5.2%.Table: LBA13Second OS IA (DCO, 21 Jun 2023; median follow-up, 15.9 months)177Lu-PSMA-617 (N=234)ARPI change (N=234)Cycles, median (range)6.0 (1–6)–rPFSaEvents, n (%)115 (49.1)168 (71.8)Median (95% CI), months12.02 (9.30, 14.42)5.59 (4.17, 5.95)HR (95% CI), p0.43 (0.33, 0.54), <0.0001TTW in FACT-P TotalbEvents, n (%)167 (71.4)187 (79.9)Median (95% CI), months7.46 (6.08, 8.51)4.27 (3.48, 4.53)HR (95% CI)0.59 (0.47, 0.72)N=105N=103ORRc, % (95% CI)41.9 (32.3, 51.9)12.6 (6.9, 20.6)N=44N=13DORc, median (95% CI), months17.1 (11.6, NE)10.1 (4.6, NE)aRadiographic progression or death bTime to worsening in FACT-P Total, clinical disease progression, or death cSoft tissue only NE, not estimable. Open table in a new tab aRadiographic progression or death bTime to worsening in FACT-P Total, clinical disease progression, or death cSoft tissue only NE, not estimable. 177Lu-PSMA-617 prolonged rPFS vs ARPI change in taxane-naive pts with PSMA+ mCRPC, with a favourable safety profile.
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