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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
3 s! @9 U0 |& q" ? 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。- v' L3 \5 k7 }4 L7 z7 \! X
- q- Z# I9 b; ^- v- w2 k+ K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。, U5 I5 {, I9 W0 R# _* a
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。2 [$ s, X2 z. z- f
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。
$ m( D; A; G: B; A* f( O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。" m6 c+ H# A I
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。5 {2 B; A* m! T; R3 R: |
详细英文报道：% ?' a8 t! ~" u/ Y
Shares of South San Francisco-based Oxigene ($OXGN) slumped this morning, dropping 10% in the wake of its analysis of a Phase II study of its experimental therapy for tough-to-treat cases of ovarian cancer. The data for fosbretabulin overall were positive, putting the company on the road to a pivotal Phase III study. But an analysis from Adam Feuerstein at TheStreet may have taken the wind out of its sails.% r9 m. S4 x' h- J4 }4 |
First, the numbers:4 }, l4 H- f# Z
Investigators say that they tracked promising results in the midstage study, which recruited 107 patients with platinum-sensitive as well as platinum-resistant ovarian cancer. Combined with Avastin, the drug achieved a median progress-free survival rate--wher the disease did not worsen--of 7.3 months compared to 4.8 months for Avastin alone. In a post hoc subgroup analysis involving 27 platinum-resistant patients (the toughest ones to treat) there was an even better outcome: 6.7 months of PFS versus 3.4 months in the Avastin-only arm.
4 g7 Q0 t$ ?. `6 m" L' b7 r& J"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."2 X1 {7 _, s4 L+ ~
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.) X0 M. w! ^& D7 y- [/ C3 l: Y0 [
If 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.
" V; y+ j' P7 S* |Perhaps, suggests Feuerstein, the company should go a different route and try a combination with Votrient.
% ~0 |( V' X/ v+ `! O& P, cInvestors, 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.7 h% A: X9 v$ ~+ S/ w
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