Apalutamide for metastatic castration-sensitive prostate cancer: final analysis of the Asian subpopulation in the TITAN trial.

Byung Ha Chung; Jian Huang; Hiroji Uemura; Young Deuk Choi; Zhang-qun YE; Hiroyoshi Suzuki; Taek Won Kang; Da-lin HE; Jae Young Joung; Sabine D Brookman-may; Sharon Mccarthy; Amitabha Bhaumik; Anildeep Singh; Suneel Mundle; Simon Chowdhury; Neeraj Agarwal; Ding-wei YE; Kim N Chi; Hirotsugu Uemura

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Apalutamide for metastatic castration-sensitive prostate cancer: final analysis of the Asian subpopulation in the TITAN trial.

Author: Byung Ha CHUNG ¹ ; Jian HUANG ² ; Hiroji UEMURA ³ ; Young Deuk CHOI ⁴ ; Zhang-Qun YE ⁵ ; Hiroyoshi SUZUKI ⁶ ; Taek Won KANG ⁷ ; Da-Lin HE ⁸ ; Jae Young JOUNG ⁹ ; Sabine D BROOKMAN-MAY ¹⁰ ; Sharon MCCARTHY ¹¹ ; Amitabha BHAUMIK ¹¹ ; Anildeep SINGH ¹² ; Suneel MUNDLE ¹¹ ; Simon CHOWDHURY ¹³ ; Neeraj AGARWAL ¹⁴ ; Ding-Wei YE ¹⁵ ; Kim N CHI ¹⁶ ; Hirotsugu UEMURA ¹⁷
Author Information

1. Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, South Korea.
2. Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510123, China.
3. Yokohama City University Medical Center, Minami-ku, Yokohama, Kanagwa 232-0024, Japan.
4. Severance Hospital, Yonsei University College of Medicine, Seoul 03722, South Korea.
5. Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
6. Toho University Sakura Medical Center, Chiba 285-0841, Japan.
7. Chonnam National University Hospital and Medical School, Gwangju 61469, South Korea.
8. Department of Urology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
9. Prostate Cancer Center, National Cancer Center, Goyang 10408, South Korea.
10. Janssen Research and Development, Spring House, PA 19002, USA.
11. Janssen Research and Development, Raritan, NJ 08869, USA.
12. Janssen Medical Affairs, Asia Pacific, Singapore 118222, Singapore.
13. Guy's and St Thomas' NHS Foundation Trust, London SE1 4YB, UK.
14. University of Utah Huntsman Cancer Institute, Salt Lake City, UT 84112, USA.
15. Fudan University Shanghai Cancer Center, Shanghai 200032, China.
16. Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia V6H 3Z6, Canada.
17. Kindai University, Faculty of Medicine, Osaka-Sayama 589-8511, Japan.
Publication Type:Journal Article
MeSH: Male; Humans; Prostatic Neoplasms/pathology*; Androgen Antagonists/therapeutic use*; Prostate-Specific Antigen; Castration; Prostatic Neoplasms, Castration-Resistant/drug therapy*
From: Asian Journal of Andrology 2023;25(6):653-661
CountryChina
Language:English
Abstract: The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial showed improvement in overall survival (OS) and other efficacy endpoints with apalutamide plus androgen deprivation therapy (ADT) versus ADT alone in patients with metastatic castration-sensitive prostate cancer (mCSPC). As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer, a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian subpopulation. Event-driven endpoints were OS, and time from randomization to initiation of castration resistance, prostate-specific antigen (PSA) progression, and second progression-free survival (PFS2) on first subsequent therapy or death. Efficacy endpoints were assessed using the Kaplan-Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for multiplicity. Participating Asian patients received once-daily apalutamide 240 mg ( n = 111) or placebo ( n = 110) plus ADT. After a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide, apalutamide reduced the risk of death by 32% (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.42-1.13), risk of castration resistance by 69% (HR: 0.31; 95% CI: 0.21-0.46), PSA progression by 79% (HR: 0.21; 95% CI: 0.13-0.35) and PFS2 by 24% (HR: 0.76; 95% CI: 0.44-1.29) relative to placebo. The outcomes were comparable between subgroups with low- and high-volume disease at baseline. No new safety issues were identified. Apalutamide provides valuable clinical benefits to Asian patients with mCSPC, with an efficacy and safety profile consistent with that in the overall patient population.