打开APP

Puma抗癌药neratinib大获成功——销售峰值有望超$60亿

  1. neratinib
  2. Puma
  3. 抗癌药

来源:生物谷 2014-07-25 10:59

Puma抗癌药neratinib III期临床大获成功,股价暴涨220%。此前,该药在II期临床中击败罗氏重磅药物赫赛汀(Herceptin),有分析师预测,该药上市后的峰值将超过60亿美元。

2014年7月24日讯 /生物谷BIOON/ --生物技术公司Puma 7月23日公布了实验性抗癌药neratinib(来那替尼,代码PB272)III期临床研究(ExteNET)的积极顶线数据。ExteNET研究是一项双盲、安慰剂对照III期研究,在2812例已接受手术和赫赛汀(Herceptin)辅助治疗的早期HER2阳性乳腺癌女性患者中开展,研究中,患者在完成赫赛汀辅助治疗后,随机分配接受为期一年的neratinib或安慰剂辅助治疗。试验中,患者随机化分配之后开始进行2年时间的随访,统计疾病复发、原位性管腺癌(DCIS)或死亡,该研究的主要终点为无病生存期(DFS)。

数据表明,与安慰剂相比,neratinib使无病生存期改善33%,具有统计学显著差异(p=0.0046)。此外,与安慰剂相比,neratinib使次要终点原位性管腺癌无病生存期(DFS-DCIS)改善达37%,同样具有统计学显著差异(p=0.0009)。该项研究的详细数据将提交至未来的科学会议。根据该项研究的积极数据,Puma计划于2015年第一季度向FDA提交neratinib的监管文件,寻求批准用于扩展期辅助治疗。

消息发布后,Puma公司股价暴涨220%。关于neratinib在III期临床的出彩表现,分析师们持有不同的乐观意见。一些分析师认为,该药的III期成功,有望使neratinib成为年销售额突破10亿美元的重磅药物。而另一些分析师认为,该药将在2028年达到60亿美元的销售峰值。

今年4月,Puma公布了neratinib一项II期研究(I-SPY 2)的积极数据,表明neratinib用于HER2阳性乳腺癌时,疗效优于罗氏赫赛汀。

详情:《Puma制药neratinib用于HER2阳性乳腺癌疗效优于罗氏赫赛汀》

关于neratinib:

neratinib是一种口服、不可逆、泛ErbB受体酪氨酸激酶抑制剂,能有效抑制ErbB1和ErbB2,其作用机制与罗氏赫赛汀(曲妥珠单抗)及乳腺癌新药Perjeta(帕妥珠单抗)不同,后2者为单克隆抗体药物,靶向于HER2阳性癌细胞表面的HER2受体。Perjeta联合Herceptin及多西紫杉醇化疗被认为能够对HER2信号传导通路提供更全面的封锁。(生物谷Bioon.com)

英文原文:Puma Biotechnology Announces Positive Top Line Results from Phase III PB272 Trial in Adjuvant Breast Cancer (ExteNET Trial)

Neratinib Achieves Statistically Significant Improvement in Disease Free Survival Company Plans to File for Regulatory Approval in First Half of 2015

LOS ANGELES, Calif., July 22, 2014 - Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced top line results from the Phase III clinical trial of Puma's investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer (ExteNET Trial). The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer.

More specifically, the ExteNET trial enrolled 2,821 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial.

The primary endpoint of the trial was disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ (DFS-DCIS). The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in disease free survival including ductal carcinoma in situ versus placebo. The hazard ratio was determined to be 0.63 which was statistically significant with a p-value of 0.0009. Based on these results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015.

Full results of the ExteNET trial for PB272 will be presented at a future scientific meeting

“We are very pleased with the results of the ExteNET trial with neratinib. This represents the first trial with a HER2 targeted agent that has shown a statistically significant benefit in the extended adjuvant setting, which we believe provides a meaningful point of differentiation for neratinib in the treatment of HER2 positive breast cancer,” said Alan H. Auerbach, Chief Executive Officer and President. “While the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need for further improvement in outcome in order to attempt to further reduce this risk of recurrence. The results of the ExteNET study demonstrate that we may be able to provide this type of improvement with neratinib to further help the patients with this disease.”

Puma Biotechnology Announces Amendment to Neratinib Licensing Agreement with Pfizer

LOS ANGELES, Calif., July 22, 2014 - Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced an amendment to its licensing agreement with Pfizer for Puma's investigational drug PB272 (neratinib). Puma is currently developing PB272 for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.

At the time that Puma licensed PB272 from Pfizer, a number of ongoing clinical trials (legacy clinical trials) that had been previously initiated by Pfizer were transferred to Puma. The original license agreement set a limit on the amount of external expenses that Puma would incur in completing these legacy clinical trials. Puma reached this limit in the fourth quarter of 2012. The original license agreement also provided that Pfizer would be responsible for all expenses for these ongoing legacy trials above the pre-determined limit until the trials were completed.

The amendment to the license agreement provides that Puma will now be solely responsible for the expenses associated with the ongoing legacy clinical trials. Puma anticipates that this will result in an increase in research and development expenses, which will total approximately $30 million. Puma further anticipates that a significant percentage of this approximately $30 million will occur in 2014 and will decrease over time until the trials are completed.

In addition, according to the terms of the original license agreement, upon commercialization of neratinib, Puma is obligated to pay Pfizer incremental annual royalties ranging between 10 to 20 percent of net sales of neratinib. Under the terms of the amendment to the license agreement, upon commercialization of neratinib, Puma will be obligated to pay Pfizer annual royalties on net sales of neratinib at a fixed rate in the low- to mid- teens.

“We are pleased to enter into this amendment to the licensing agreement for neratinib. By assuming responsibility for the expenses associated with the ongoing legacy clinical trials, and by fixing the royalty rate for the drug at a reduced rate, we believe that we have significantly improved the potential value of the drug,” said Alan H. Auerbach, Chief Executive Officer and President.

版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->