印度代购提示：MONARCH plus是Ⅲ期国际多中心的临床研究，主要目的就是在MONARCH 2和MONARCH 3研究结果已经出来后，获得中国患者的证据，并为全球的数据做出贡献。共入组463例患者，涵盖两组不同人群：队列A,主要为内分泌初治患者，共纳入306名患者2:1随机分组接受玻玛西林Abemaciclib联合NSAI或安慰剂联合NSAI;队列B,入组人群为内分泌治疗敏感性低的患者(见下图)，共纳入157名患者，2:1随机分组接受Abemaciclib联合氟维司群(F)或安慰剂联合氟维司群治疗。

MONARCH Plus is a Phase iii international multi-center clinical study. The main purpose of MONARCH Plus is to obtain evidence from Patients in China and contribute to global data after the results of MONARCH 2 and MONARCH 3 studies have been published. A total of 463 patients were enrolled, including two different groups: cohort A, mainly initial endocrinology patients, A total of 306 patients were enrolled 2:1 randomly assigned to receive bomazillin Abemaciclib combined with NSAI or placebo combined with NSAI; Cohort B, a group of patients with low sensitivity to endocrine therapy (see figure below), included 157 patients who were randomized 2:1 to receive Abemaciclib in combination with flulvesant (F) or placebo in combination with flulvesant.

　　印度代购提示：该研究主要终点：队列A中研究者评估的无进展生存期(PFS)，关键次要终点：队列B中研究者评估的PFS,其他次要终点：总生存期(OS)、客观缓解率(ORR)、疾病控制率(DCR)、临床获益率(CBR)和安全性。

玻玛西林

　　印度代购提示：在队列A中，靶向联合治疗组的PFS均较NSAI单药治疗组显著延长，中位PFS在 玻玛西林Abemaciclib联合NSAI组尚未达到，NSAI单药组达14.73个月( HR = 0.499. 95%CI: 0.346～0.719. P = 0.001)。在队列B中，靶向联合治疗组的PFS较氟维司群单药治疗组亦显著延长，中位PFS在联合治疗组为11.47月，在氟维司群单药治疗组5.59月( HR = 0.376. 95%CI: 0.240～0.588. P < 0.001)。

　　印度代购提示：联合治疗组也显著提高了疾病客观缓解率(队列A:ORR 65.9% vs 36.1%, P < 0.0001;队列B:50% vs 10.5%, P < 0.0001)，和临床获益率(队列A:CBR 82.4% vs 61.4%, P = 0.0004;队列B:77.5% vs 42.1%，P = 0.0001)，其研究结果与MONARCH2/3获益一致。

　　印度代购提示：MONARCH plus研究中联合治疗组最常见的治疗相关不良反应为， 中性粒细胞减少(Abemaciclib + NSAI vs NSAI: 80% vs 20.2%, Abemaciclib + F vs F:80.8% vs 18.9%)，白细胞减少(Abemaciclib + NSAI vs NSAI: 76.1% vs 27.3%, Abemaciclib + F vs F:82.7% vs 22.6%)和腹泻(Abemaciclib + NSAI vs NSAI: 80.0% vs 16.2%, Abemaciclib + F vs F:78.8% vs 9.4%)，没有发现新的不良事件。

The most common treatment-related adverse events in the combination therapy group in MONARCH Plus were neutropenia (Abemaciclib + NSAI vs NSAI: 80% vs 20.2%, Abemaciclib + F vs F:80.8% vs 18.9%), leukopenia (Abemaciclib + NSAI vs NSAI: 76.1% vs 27.3%, Abemaciclib + F vs F:82.7% vs 22.6%, and diarrhea (Abemaciclib + NSAI vs NSAI: 80.0% vs 16.2%, Abemaciclib + F vs F:78.8% vs 9.4%), and no new adverse events were observed.