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Poster session 14

1795P - China ARCHES: A multicenter phase III randomized double-blind placebo (PBO)-controlled efficacy and safety trial of enzalutamide (ENZA) + androgen deprivation therapy (ADT) vs PBO + ADT in Chinese patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC)

Date

21 Oct 2023

Session

Poster session 14

Topics

Tumour Site

Prostate Cancer

Presenters

Gongqian Zeng

Citation

Annals of Oncology (2023) 34 (suppl_2): S954-S1000. 10.1016/S0923-7534(23)01946-4

Authors

F. Zhou1, G. Zeng2, H. Guo3, Z. Hu4, X. Zhang5, D. He6, Z. He7, D. Zhang8, Y. Li1, H. Kadeerbai9, Y. Liu10, D. Ye11

Author affiliations

  • 1 Department Of Urology, Sun Yat-sen University – Cancer Center, 510060 - Guangzhou/CN
  • 2 Department Of Urology, Hunan Cancer Hospital, 410013 - Changsha/CN
  • 3 Department Of Urology, Nanjing Drum Tower Hospital, Nanjing/CN
  • 4 Department Of Urology, Tongji Hospital, Tongji Medical College of HUST, 200065 - Wuhan/CN
  • 5 Department Of Urology, Wuhan Union Hospital, 430021 - Wuhan/CN
  • 6 Department Of Urology, First Affiliated of Xi'an Communication University, Xi'an Shaanxi/CN
  • 7 Department Of Urology, Peking University First Hospital, 100034 - Beijing/CN
  • 8 Department Of Urology, Zhejiang Provincial People's Hospital, Hangzhou/CN
  • 9 Department Of Data Science, Astellas Pharma China, Beijing/CN
  • 10 Medical Development Department, Astellas Pharma China, Beijing/CN
  • 11 Department Of Urology, Fudan University – Shanghai Cancer Center (FUSCC), 200032 - Shanghai/CN

Resources

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Abstract 1795P

Background

In the global ARCHES trial (NCT02677896), ENZA + ADT improved overall survival and radiographic progression-free survival (rPFS) vs PBO + ADT in pts with mHSPC. The China ARCHES trial evaluated the efficacy and safety of ENZA + ADT vs PBO + ADT in Chinese pts with mHSPC.

Methods

Chinese men with mHSPC (positive bone scan or CT scan) were randomized 2:1 to ENZA (160 mg/day) + ADT or PBO + ADT, stratified by disease volume and prior docetaxel therapy. Treatment continued until intolerability or confirmed radiographic progression. The primary endpoint was time to prostate-specific antigen (PSA) progression (TTPP; PSA progression defined as ≥25% increase and absolute increase of ≥2 ng/mL above the nadir, confirmed after ≥3 weeks), based on central laboratory test. Selected secondary endpoints included rPFS, time to castration resistance (TTCR), PSA undetectable (<0.2 ng/mL) rate in patients with detectable PSA at baseline, and safety. We report the results of a prespecified interim analysis (63 TTPP events accrued).

Results

At data cut-off (November 18, 2022), 180 pts (ENZA + ADT, n=120; PBO + ADT, n=60) had been randomized from 27 centers in China (median age, 68.5 years). Baseline characteristics were balanced between treatment arms. Median treatment duration with ENZA + ADT vs PBO + ADT was 25.66 vs 15.11 months. Based on 63 centrally confirmed PSA progressions (ENZA + ADT, 23; PBO + ADT, 40), ENZA + ADT significantly reduced the risk of PSA progression by 87% vs PBO + ADT (Table). rPFS, TTCR, and PSA undetectable rate were among the secondary endpoints improved with ENZA + ADT vs PBO + ADT. Safety outcomes in pts from China were consistent with those in the global ARCHES population. Table: 1795P

Endpoint ENZA + ADT N=120 PBO + ADT N=60 Hazard ratioa (95% CI) p value
TTPPb (95% CI)c NR (NR, NR) 9.2 (6.54, 17.48) 0.13 (0.076, 0.222) <0.0001d
rPFSb (95% CI)c NR (28.25, NR) 19.4 (13.63, NR) 0.33 (0.196, 0.556) <0.0001d,e
TTCRb (95% CI)c NR (31.18, NR) 8.3 (6.41, 14.69) 0.172 (0.107, 0.276) <0.0001d,e
PSA undetectable, % (95% CI)f 76.3 (67.4, 83.8) 22.8 (12.7, 35.8) <0.0001e,g

aCox proportional hazards modelh bMedian months: Kaplan-Meier method cBrookmeyer and Crowley method dLog-rank testh eNominal p value fClopper-Pearson method based on exact binomial distribution gCochran-Mantel-Haenszel score testh hStratified model/test CI=confidence interval; N=no. of randomized pts; NR=not reached.

Conclusions

Efficacy and safety results in China ARCHES were generally consistent with those in the global ARCHES trial.

Clinical trial identification

Editorial acknowledgement

Medical writing and editorial assistance were provided by Marietou Daou, MSc, and Jane Beck, MA, from Complete HealthVizion, IPG Health Medical Communications, funded by the study sponsors.

Legal entity responsible for the study

Astellas Pharma Inc.; Pfizer Inc.

Funding

This study was funded by Astellas Pharma Inc. and Pfizer Inc., the co-developers of enzalutamide.

Disclosure

F. Zhou, Z. Gongqian, H. Guo, Z. Hu, D. He, D. Zhang, Y. Li, H. Kadeerbai, Y. Liu, D. Ye: Non-Financial Interests, Institutional, Other, Study funding and support for Medical Writing/editing: Astellas; Non-Financial Interests, Institutional, Other, Medical writing/editing support: Complete HealthVizion. X. Zhang, Z. He: Non-Financial Interests, Institutional, Writing Engagement: Astellas Pharma Inc.

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