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Oxigene治疗卵巢癌药物fosbretabulin临床二期研究结果遭质疑 发布日期：2014-11-15 来源：新药汇
6 {0 ?" h. P) i' `* |. Y 最近著名的癌症药物研发公司Oxigene公司开发的卵巢癌药物fosbretabulin临床二期研究数据显示积极，然而这也未能给公司带来广泛的赞扬。
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, D5 U, L; E9 N/ b1 @. c- U8 ~$ i作为生物医药公司，其研发工作可以说是公司的核心命脉。每一次临床研究的成功与失败都直接牵动着公司未来的发展状况。1 k E0 P5 {, R0 e9 E& f* {' n
在这项研究中，研究人员招募了包括铂敏感和抗铂类型在内的共计107名患者。结果显示，fosbretabulin与Avastin联用将患者的平均无进展生存期由单独使用Avastin的4.8个月延长至7.3个月；这一结果体现在27名抗铂卵巢癌患者组时表现为3.4个月延长至6.7个月。获得了这一结果的Oxigene公司高兴地表示公司正在进行进一步临床三期研究计划的设计。0 F1 o& ~. A/ x% R* R o
乍一看上去，这一结果表明fosbretabulin与Avastin联用能够很好的延长患者的生存期。然而，分析人士却认为这一结果或许并不像看上去的那样美好。2 T2 R7 ?- ^' u
他们指出，Oxigene公司的这一设计思路的问题在于Avastin的选择上。众所周知，Avastin治疗卵巢癌的研究正在处于后期研究和审核的阶段，FDA并不一定会批准其作为治疗这一肿瘤类型的药物。其次是，随着目前肿瘤治疗方案的发展，许多药物都会选择和化疗用药结合使用，而一旦Avastin与化疗药物联合用药的方案被FDA批准为治疗卵巢癌的标准方案，势必将增大Oxigene公司的fosbretabulin与Avastin的研究成本和获批难度。因为Oxigene公司必须向FDA证明其方案要优于前者。这些问题无形中给fosbretabulin的研究工作额外增添了许多困难。
* E; }9 F, e; u6 H7 Y0 v$ m+ y: n受此评论的影响，Oxigene公司的股价也应声下跌了10％，反映出投资者对公司研发前景的担忧。
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, Y% Y8 d. Q3 U4 A$ C q8 KShares of South San Francisco-based Oxigene ($OXGN) slumped this morning, dropping 10% in the wake of its analysis of a Phase II study of its experimental therapy for tough-to-treat cases of ovarian cancer. The data for fosbretabulin overall were positive, putting the company on the road to a pivotal Phase III study. But an analysis from Adam Feuerstein at TheStreet may have taken the wind out of its sails.
7 I9 R( }) R* i2 r- OFirst, the numbers:
4 N3 h c0 Y' U- zInvestigators say that they tracked promising results in the midstage study, which recruited 107 patients with platinum-sensitive as well as platinum-resistant ovarian cancer. Combined with Avastin, the drug achieved a median progress-free survival rate--wher the disease did not worsen--of 7.3 months compared to 4.8 months for Avastin alone. In a post hoc subgroup analysis involving 27 platinum-resistant patients (the toughest ones to treat) there was an even better outcome: 6.7 months of PFS versus 3.4 months in the Avastin-only arm.
' ^5 a3 R' U2 M& K! M"We believe that these compelling data show fosbretabulin has a meaningful benefit in recurrent ovarian cancer, particularly in platinum-resistant patients who have extremely limited treatment options," said Dai Chaplin, Oxigene's president and CEO. "We now look forward to discussing these findings with the regulatory agencies to determine a potential path forward for fosbretabulin in ovarian cancer."" U" q, P6 a h' E) ^
Here's wher it ran into trouble, notes Feuerstein, an analyst who's done a considerable amount of work in the cancer field. A decision on using Avastin for ovarian cancer is looming, but hasn't arrived yet--complicating any analysis of a combination drug study like this. Avastin, by the way, achieved a solid PFS but not a statistically significant overall survival benefit for ovarian cancer patients, which may not prevent its approval.
0 R2 A5 {6 U7 g; u2 w9 R& KIf Avastin plus chemo becomes the standard of care in this area, then Oxigene will face some big challenges in designing a Phase III trial, notes Feuerstein. If the biotech decides to run a non-inferiority study, it will need a big and expensive patient population to examine. If it tries to beat Avastin/chemo, it faces a very tall order. And if Avastin is rejected, that makes Oxigene's task even more difficult.
4 ]; H/ j! g9 H' W. fPerhaps, suggests Feuerstein, the company should go a different route and try a combination with Votrient.
: V& {1 C: I- Q$ ?1 l- Y7 J+ ?Investors, looking at the complications, evidently didn't see any easy answers this morning. And with its share price down today, Oxigene's execs will be challenged to provide some answers. T5 G) Y+ X( U8 F7 |5 F: N
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