Puma生物技术公司4月7日公布了抗癌药neratinib（来那替尼）一项II期研究（I-SPY 2）的数据。该项研究在193例术前新诊具有高复发风险（根据前期肿瘤属性判断，包括肿瘤大小、激素受体HR状态、HER2状态、MammaPrint-70基因指纹检测）的2阶段或更晚阶段（肿瘤至少2.5cm）的乳腺癌患者开展，调查了将neratinib添加至标准化疗用于新辅助治疗（neoadjuvant setting）时相对于标准化疗的疗效。研究中根据激素敏感性及基因指纹检测等因素将患者划分为10个组，主要终点是手术时乳房和淋巴结中的病理学完全缓解（pathologic complete response，pCR）。
新辅助治疗是指在手术治疗前予以的治疗措施，主要包括化疗和放疗，其目的是减小肿瘤的体积，使其能够更容易手术移除。
研究数据表明，用于治疗HER2阳性乳腺癌时，neratinib疗效优于罗氏（Roche）乳腺癌药物赫赛汀（Herceptin）：neratinib+化疗治疗组，有39%的患者取得了病理学完全缓解（pCR），赫赛汀+化疗治疗组为23%。病理学完全缓解（pCR）意味着乳房或淋巴结中没有肿瘤存在的迹象。
该项研究还发现，在基因检测表明存在癌症复发高风险的乳腺癌患者中，与标准护理相比，neratinib取得了更高的病理学完全缓解率（45% vs 29%）。
目前，Puma公司正在设计III期试验，调查neratinib用于HER2阳性患者群体及乳腺癌复发高风险群体的治疗。
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。
Puma drug better than Herceptin in HER2 breast cancers -trial
(Reuters) - A mid-stage trial of Puma Biotechnology's experimental drug neratinib showed that it was more effective, given before surgery, than Herceptin, the Roche drug commonly used in women with a type of breast cancer fueled by a protein called HER2.
The trial involved treating 193 newly diagnosed patients prior to surgery. ab0ut 39 percent of HER2 patients given a combination of neratinib and chemotherapy achieved a "pathologic complete response," compared with 23 percent of women treated with chemo and Herceptin.
Pathologic complete response, or pCR, means there is no remaining evidence of the tumor in the breast or lymph nodes.
The trial also found that the experimental drug resulted in a higher rate of pCR, 45 percent, than standard care, 29 percent, in women with tumors for which genetic testing indicated a high probability that their cancer would return.
Alan Auerbach, Puma's chief executive officer, said the company is in the process of designing Phase 3 trials of neratinib in both HER2-positive patients and in patients with a high risk of breast cancer recurrence.
The drug, which was licensed by Puma from Pfizer Inc , is also being studied in a range of other cancer indications.
In the Phase 2 trial, due to be presented on Monday in San Diego at a meeting of the American Association for Cancer Research, patients were stratified into 10 different groups, based on hormone sensitivity and other factors.
ab0ut 25 percent of breast cancers are HER2 positive.
The Phase 2 trial used "adaptive randomization," meaning patients entering the study were assigned to treatment regimens that were performing better in patients with the same cancer subtype.
Auerbach said neratinib, a pill, has a different mechanism of action than Herceptin, a bioengineered antibody given by infusion, as well as Perjeta, a newer Roche drug approved for use in combination with Herceptin.
As a result, HER2-positive patients could potentially be treated with a regimen of chemotherapy, plus Herceptin, Perjeta and neratinib, he said.
Breast cancer is the most common cancer among women, with ab0ut 1.4 million new cases diagnosed each year and more than 450,000 women dying of the disease annually, according to the World Health Organization.
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