2017年4月24日礼来公司宣布其在研产品abemaciclib的一项phase III研究MONARCH 3，在预先设定的中期分析中，达到主要研究终点PFS。另外，次要研究终点ORR也有改善。
该项phase III研究旨在评估abemaciclib（CDK4/6抑制剂）联合芳香化酶抑制剂（来曲唑或阿那曲唑）与单用芳香化酶抑制剂，在激素受体阳性（HR+）和Her2阴性晚期乳腺癌患者中的有效性与安全性。详细的有效性和安全性数据将在2017年下半年的医学学术会议公布，大叔预测是2017 ESMO或者2017 SABCS。
MONARCH3 是一项双盲的全球phase III研究，旨在探寻abemaciclib（CDK4/6抑制剂）联合芳香化酶抑制剂（来曲唑或阿那曲唑）作为内分泌初始治疗与单用芳香化酶抑制剂，在激素受体阳性（HR+）和Her2阴性晚期（局部复发或转移）未经全身治疗乳腺癌患者中的有效性与安全性。该研究将493例患者随机分为两组，一组接受abemaciclib（150mg 每日2次口服）与来曲唑（2.5mg每日一次）或阿那曲唑（1mg每日一次）联合治疗，另外一组接受安慰剂与来曲唑（2.5mg每日一次）或阿那曲唑（1mg每日一次）治疗。治疗直至病情进展或出现不可耐受毒性。主要研究终点为PFS，次要研究终点为ORR、OS和安全性。不良反应与abemaciclib先前的研究一致，最常见的不良反应为腹泻、中性粒细胞降低、疲乏和恶性。
MONARCH 3 中期分析之后，礼来将于2017年第三季度启动全球注册申请，基于MONARCH1 和MONARCH 2研究的注册申请将于2017年第二季度启动。
Lilly Announces Phase 3 MONARCH 3 Breast Cancer Study of Abemaciclib Demonstrated Superior Progression-Free Survival at Interim Analysis
The Phase 3 study compared abemaciclib in combination with an aromatase inhibitor versus an aromatase inhibitor alone in patients with HR+, HER2- advanced breast cancer
INDIANAPOLIS, April 24, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that following a pre-planned interim analysis for MONARCH 3, the trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS). In addition, improvement was shown in a key secondary endpoint of objective response rate (ORR). The Phase 3 study evaluated abemaciclib, a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, in combination with an aromatase inhibitor (letrozole or anastrozole) compared to treatment with an aromatase inhibitor alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Detailed efficacy and safety results will be presented at a medical meeting in the second half of the year.
"Today marks another important milestone in our clinical development program for abemaciclib, a drug we believe has the potential to be best in class," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "We are very excited about the results seen in patients with breast cancer, from single-agent activity to clinically meaningful benefit when used in combination with fulvestrant or aromatase inhibitors. Along with additional abemaciclib clinical trials in other tumor types, these data underscore Lilly's commitment to delivering life-changing medicines to treat and cure people living with cancer around the world."
The global Phase 3, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with advanced (locoregionally recurrent or metastatic) breast cancer who have had no prior systemic treatment for advanced disease. A total of 493 patients were randomized to receive 150 mg of abemaciclib or placebo orally twice a day without interruption, given in combination with either 1 mg of anastrozole or 2.5 mg of letrozole once daily until disease progression or unacceptable toxicity. The primary endpoint of the study was PFS, with key secondary endpoints of ORR, overall survival and safety. The adverse events were generally consistent with previous studies of abemaciclib, with the most common adverse events being diarrhea, neutropenia, fatigue, and nausea.
Following this MONARCH 3 interim analysis, Lilly intends to begin global submissions of these results in the third quarter of 2017. In addition, Lilly intends to initiate MONARCH 1 and MONARCH 2 submissions beginning in the second quarter of 2017.
Other MONARCH trials currently underway include: monarcHER, which is evaluating abemaciclib plus trastuzumab (with or without fulvestrant) in women with HR+, HER2+ locally advanced or metastatic breast cancer, and MONARCH plus, a Phase 3 study of abemaciclib in combination with endocrine therapies to support registration in China. In addition, Lilly has an ongoing Phase 3 trial evaluating abemaciclib in lung cancer. Lilly is also evaluating abemaciclib in patients with brain metastases, as well as in patients with pancreatic cancer.
https://investor.lilly.com/releasedetail.cfm?ReleaseID=1022428
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