Deciphera's GIST Drug Succeeds in Pivotal Study, Stock Up 80%

Deciphera公司胃肠道间质瘤药物ripretinib III期试验达到主要终点,股价大涨

2019-08-15 16:07:00 Zacks

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Deciphera Pharmaceuticals, Inc. DCPH announced encouraging data from a pivotal phase III study — INVICTUS — evaluating its pipeline candidate, ripretinib, in patients with gastrointestinal stromal tumors in fourth or later-line setting. Data from the study demonstrated that treatment with ripretinib led to significant reduction in the risk of disease progression or death. On the back of this encouraging data, the company announced that it will file a new drug application in the first quarter of 2020, seeking approval of ripretinib in a similar indication. Shares of Deciphera skyrocketed almost 80% on Aug 13, following the study data announcement. In fact, the company’s shares have rallied 71% so far this year against the industry’s decline of 2.1%. The INVICTUS study evaluated KIT and PDGFRα inhibitor, ripretinib, in GIST patients previously treated with at least Novartis’ NVS Gleevec (imatinib), Pfizer’s PFE Sutent (sunitinib) and Bayer’s BAYRY Stivagra (regorafenib). Data from the study showed ripretinib met the primary endpoint of progression-free-survival (“PFS”). The median progression-free-survival or PFS was 6.3 months for ripretinib, significantly higher than 1 month for placebo or 85% reduction in risk of disease progression or death. Median overall survival was 15.1 months for ripretinib versus 6.6 months for placebo. Although ripretinib improved objective response rate or ORR  (9.4%), it was not statistically significant compared to placebo (ORR 0%). In a separate press release, Deciphera announced updated data from a phase I study evaluating ripretinib in GIST patients in second, third or fourth-line settings. Data showed that treatment with ripretinib led to median PFS of 42 weeks, 40 weeks and 30 weeks, and achieved ORR of 30%, 23% and 15% in second-, third- and fourth-line setting, respectively. Updated data demonstrates that median PFS was sustained across all arms of the study. Moreover, the data supports ongoing phase III study — INTRIGUE — evaluating ripretinib in second-line GIST.
Deciphera Pharmaceuticals , Inc . DCPH 公布了一项关键的 III 期研究—— INVITECUS ——的令人鼓舞的数据,该研究评估了其管道候选药物利普瑞替尼( riprinib )在第四期或晚期胃肠道间质肿瘤患者中的应用。来自研究的数据表明,利福替尼治疗可显著降低疾病进展或死亡的风险。 在这一令人鼓舞的数据的支持下,该公司宣布,将在2020年第一季度提交一份新药申请,以类似的迹象寻求利普瑞替尼的批准。 研究数据公布后, Deciphera 的股价在8月13日飙升了近80%。事实上,该公司股价今年迄今已上涨71%,而该行业的跌幅为2.1%。 INVITECUS 研究评估了 GIST 患者 KIT 和 PDGFR α抑制剂利瑞替尼的疗效,这些患者之前至少接受过诺华(Novartis)公司的 NVS Gleevec (伊马替尼)、辉瑞(Pfizer)公司的 PFE Suale (苏尼替尼)和拜耳(Bayer)公司的 BAYRY Stivara (雷贝拉芬ib )的治疗。 来自研究的数据显示利瑞替尼达到了无进展生存(“ PFS ”)的主要终点。利福韦替尼的中位无进展生存期或 PFS 为6.3个月,显著高于安慰剂1个月或疾病进展或死亡风险降低85%。利普瑞替尼的总生存期中位数为15.1个月,而安慰剂为6.6个月。尽管利普瑞替尼改善了客观反应率或 ORR (9.4%),但与安慰剂( ORR 0%)相比,其统计学意义不大。 在另一份新闻稿中, Deciphera 公布了第一阶段研究的最新数据,该研究评估了 GIST 患者在第二、第三或第四线设置里的瑞替替尼。数据显示,利培替尼治疗后的 PFS 中位数分别为42周、40周和30周,在二线、三线和四线治疗中分别达到30%、23%和15%的 ORR 。更新的数据表明,在研究的所有部门中位 PFS 均得到维持。此外,这些数据支持正在进行的第三阶段研究—— INTRIGUE ——评估第二线 GIST 中的瑞替替尼。

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