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拜耳力推白血病新药copanlisib以巩固其癌症研究地位

新药编辑:新特药 更新时间:2015-04-16

2015年4月15日讯 /tumor.net.cn/ --著名制药公司拜耳公司最近正在酝酿一系列大动作。公司计划开展一系列关于其治疗白血病药物copanlisib的晚期临床研究。Copanlisib是一种PI3K信号通路抑制剂,通过阻断阻断这种通路,研究人员相信copanlisib能够抑制白血病和淋巴瘤患者体内的癌细胞生长。

为了进一步证明这种药物的前景,今年年中拜耳公司将展开两项临床三期研究。第一项是与安慰剂组对比,判断copanlisib治疗一种罕见的非霍奇金淋巴瘤(NHL)效果,而所招募的所有受试者都是在接受了罗氏公司畅销药物Rituxan治疗失败的患者;第二项研究是copanlisib与Rituxan联用与单独使用Rituxan治疗效果对比。此外,拜耳公司还计划开展一项关于copanlisib治疗弥漫性大B细胞淋巴瘤(一种恶性NHL亚型)的临床二期研究。

拜耳副总裁Dario Mirski介绍说,NHL是一种恶性肿瘤,许多患者在接受初步治疗后常常会出现肿瘤复发。因此,临床上仍然缺乏足够多的药物选择来治疗这一肿瘤疾病,公司希望能够通过这些数据加深FDA等部门对这一药物价值的认识,并为临床NHL患者提供更多的药物治疗选择。

而吉利德公司在去年就已经上市了一种类似的PI3K抑制剂类药物Zydelig,Zydelig被FDA批准用于治疗慢性粒细胞白血病等适应症。在这一领域中最畅销药物当属强生公司和Pharmacyclics公司共同开发的Imbruvica,这种药物更是吸引艾伯维公司花费210亿美元将Pharmacyclics收入囊中。(tumor.net.cn)

详细英文报道:

Bayer is plotting a pair of Phase III trials for its lead oncology treatment, hoping to crack the crowded field of new blood cancer drugs with a targeted therapy of its own.

The drug, copanlisib, works by blocking overactive PI3K signaling, cutting off a key contributor to cancer growth in leukemias and lymphomas. By the middle of the year, Bayer expects to begin enrollment for two Phase III studies: one testing copanlisib against placebo on patients with the rare non-Hodgkin's lymphoma (NHL) who have failed on Roche's ($RHHBY) Rituxan, and a second pairing the two drugs against relapsed NHL and comparing the results against Rituxan alone. The company also plans to kick off an open-label Phase II study to see how well copanlisib can combat diffuse large B-cell lymphoma, an aggressive subtype of NHL.

The plan, Bayer said, is to hustle copanlisib to regulators in hopes of providing a new therapy option for a particularly deadly disease. And the drug, an FDA-designated orphan product, has the potential to fill a big unmet need, the company said.

"Non-Hodgkin's lymphoma is a highly heterogenous disease characterized by a chronic pattern of remissions and recurrences, and for NHL patients with disease recurrence after initial treatment, there are limited treatment options," Bayer Vice President Dario Mirski said in a statement.

Meanwhile, Gilead Sciences ($GILD) is already on the market with the PI3K-blocking Zydelig, approved last year to treat chronic lymphocytic leukemia, small lymphocytic lymphoma and relapsed follicular B-cell NHL, a subtype of copanlisib's target indication. And leading the new class of blood cancer drugs is Imbruvica from Johnson & Johnson ($JNJ) and Pharmacyclics ($PCYC), a drug promising enough to convince AbbVie ($ABBV) to shell out $21 billion for the latter company.

Bayer is betting copanlisib can help maintain its momentum in oncology. In 2013, Bayer and then-partner, now-subsidiary Algeta won FDA approval for the prostate cancer drug Xofigo, for which sales could top out at around $1.5 billion, analysts say. And the year before, the drugmaker swayed regulators with the colorectal cancer treatment Stivarga.

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