Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
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Gu Chengyuan, Wang Zengjun, Lin Tianxin, Liu Zhiyu, Han Weiqing, Zhang Xuhui, Liang Chao, Liu Hao, Yu Yang, Xu Zhenzhou, Liu Shuang, Wang Jingen, Jia Linghua, Yao Xin, Liao Wenfeng, Fu Cheng, Tan Zhaohui, He Guohua, Zhu Guoxi, Fan Rui, Yang Wenzeng, Chen Xin, Liu Zhizhong, Zhong Liqiang, Shi Benkang, Ding Degang, Chen Shubo, Wei Junli, Yao Xudong, Chen Ming, Lu Zhanpeng, Xie Qun, Hu Zhiquan, Wang Yinhuai, Guo Hongqian, Fan Tiwu, Liang Zhaozhao, Chen Peng, Wang Wei, Xu Tao, Li Chunsheng, Xing Jinchun, Liao Hong, He Dalin, Wu Zhibin, Yu Jiandi, Feng Zhongwen, Yang Mengxiang, Dou Qifeng, Zeng Quan, Li Yuanwei, Gou Xin, Zhou Guangchen, Wang Xiaofeng, Zhu Rujian, Zhang Zhonghua, Zhang Bo, Tan Wanlong, Qu Xueling, Sun Hongliang, Gan Tianyi, Ye Dingwei
Аннотация
METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT04563936.