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武田orteronel前列腺癌ELM-PC5 III期试验失败

  1. orteronel
  2. 前列腺癌
  3. 武田

来源:生物谷 2013-07-31 09:39

2013年7月30日讯 /生物谷BIOON/ --武田(Takeda)7月26日公布了ELM-PC5 III期临床研究(C21005)的中期分析数据。该研究在化疗期间或化疗后病情恶化的转移性阉割性前列腺癌(mCRPC)患者中开展,将orteronel+泼尼松(prednisone)与安慰剂+泼尼松进行了对比。

2013年7月30日讯 /生物谷BIOON/ --武田(Takeda)7月26日公布了ELM-PC5 III期临床研究(C21005)的中期分析数据。该研究在化疗期间或化疗后病情恶化的转移性阉割性前列腺癌(mCRPC)患者中开展,将orteronel+泼尼松(prednisone)与安慰剂+泼尼松进行了对比。既定的中期分析表明,与对照相比,orteronel+泼尼松可能无法达到改善总生存期(OS)的主要终点(HR 0.894, p=0.226),但在次要终点影像学无进展生存期(rPFS)方面显示出了优势(HR 0.755, p=0.00029)。该项研究中未出现安全性问题。

在咨询了医生和研究调查人员后,武田打算允许ELM-PC5研究中所有随机接受orteronel治疗的患者继续治疗。同时卫生监管部门及临床研究调查人员已被告知ELM-PC5研究已经揭盲(unblinded)。

ELM-PC5研究的揭盲,预计不会影响其他正在开展的orteronel临床试验,包括ELM-PC4关键性III期研究(C21004),该研究在化疗初治(chemotherapy-naive)mCRPC患者中开展,将orteronel+泼尼松(prednisone)与安慰剂+泼尼松进行了对比。

Orteronel是一种实验性口服、非甾体类、选择性、17,20-裂解酶抑制剂,该酶是甾体类激素(包括雄激素)生产过程中的一个关键酶。雄激素主要是由睾丸合成和分泌,肾上腺和卵巢也能分泌少量。睾丸之外的雄激素合成对阉割性前列腺癌(CRPC)的病情恶化起到了推动作用。(生物谷Bioon.com)

英文原文:Takeda Announces Unblinding of Phase 3 Study of Orteronel in Patients with Metastatic, Castration-Resistant Prostate Cancer That Progressed

Post-Chemotherapy Based on Interim Analysis

? Pre-specified interim analysis indicated study would likely not meet the primary endpoint

of improved overall survival ?

OSAKA, Japan, July 26 and CAMBRIDGE, Mass., July 25, 2013 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has unblinded the ELM-PC 5 Phase 3 study (C21005) of orteronel plus prednisone compared to placebo plus prednisone in patients with metastatic, castration- resistant prostate cancer (mCRPC) that had progressed during or following chemotherapy based on the recommendation of the Independent Data Monitoring Committee (IDMC). The pre-specified interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall survival (OS) when compared to the control arm (HR 0.894, p=0.226). The interim analysis did show an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival (rPFS) over the control arm (HR 0.755, p=0.00029). In addition, there were no safety concerns.

Takeda intends to allow all patients participating in the ELM-PC 5 study who were randomized to orteronel to continue on therapy following consultation with their physicians and study investigators. The appropriate health authorities and clinical study investigators are being notified that the ELM-PC 5 study has been unblinded.

The decision to unblind the ELM-PC 5 study is not expected to impact other ongoing company-sponsored clinical trials with orteronel, including the ELM-PC 4 pivotal Phase 3 study (C21004) comparing orteronel plus prednisone to placebo plus prednisone in patients with chemotherapy-naive mCRPC. 

“While we are disappointed that the ELM-PC 5 study did not meet the primary endpoint of improved overall survival, we remain committed to developing new therapies for patients with prostate cancer,” stated Michael Vasconcelles, M.D., Global Head of the Takeda Oncology Therapeutic Area Unit. “We would like to acknowledge with gratitude the patients, their families, and the study investigators for their significant contributions to the ELM-PC 5 trial. Takeda remains dedicated to developing innovative treatment options for patients with cancer.”

Safety and efficacy findings from the trial will be presented when fully available and analyzed.

Orteronel is an investigational oral, non-steroidal, selective inhibitor of 17,20-lyase, a key enzyme in the production of steroidal hormones.

About ELM-PC 5 (C21005)

The ELM-PC 5 (Evaluation of the Lyase inhibitor orteronel in Metastatic Prostate Cancer 5) study is a randomized, double-blind, multicenter, global Phase 3 study evaluating the safety and efficacy of orteronel plus prednisone compared with placebo plus prednisone in men with mCRPC that had progressed during or following docetaxel-based therapy. The primary endpoint was OS. The key secondary endpoints were prostate specific antigen (PSA) response, pain response at 12 weeks, and radiographic progression-free survival (rPFS).

About ELM-PC 4 (C21004)

The ELM-PC 4 (Evaluation of the Lyase inhibitor orteronel in Metastatic Prostate Cancer 4) is a randomized, double-blind, multicenter, global Phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive mCRPC.  The primary endpoints are rPFS and OS. The key secondary endpoints are PSA response, changes in circulating tumor cell (CTC) counts, and time to pain progression.

About orteronel

Orteronel, discovered by Takeda, is an investigational oral, non-steroidal, selective inhibitor of 17,20-lyase, a key enzyme in the production of steroidal hormones including androgens. Synthesis of androgens outside the testes contributes to disease progression in castration-resistant prostate cancer (CRPC).

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