研究三角公园，名词.C.2019年6月18日(环球彩乐园2专线)- G1治疗公司. (纳斯达克:GTHX), 一个临床阶段的肿瘤公司, today announced preliminary overall survival (OS) results from a randomized Phase 2 trial which demonstrated that women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone. 这项试验的详细数据将在今年晚些时候的一次医学会议上公布.
Myelopreservation结果, 客观反应率(ORR), 该试验的无进展生存期(PFS)和安全性数据为 在2018年圣安东尼奥乳腺癌研讨会上发表 (南非广播公司). Updated anti-tumor efficacy results demonstrated that women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone.
“三阴性乳腺癌是最具侵袭性的乳腺癌类型, 被诊断为转移性三叉乳腺癌的女性需要新的治疗方案. 彩乐园2期待与监管机构分享这些数据, 并将在今年晚些时候的医学会议上展示这项试验的结果,马克·维利卡说, M.D., Ph.D.，首席执行官. “作为一家致力于改善生活的公司, 癌症患者的治疗选择和结果, we’re proud to have a pipeline that now includes three investigational therapies with the potential to become new standards of care for those with breast cancer and benefit women at the earliest stages of their disease.”
本随机、开放标签二期临床试验(NCT02978716) enrolled 102 patients with mTNBC who had received 0-2 prior lines of therapy in the recurrent/metastatic setting. 在这个三臂试验中, 所有患者均接受吉西他滨/卡铂(GC)化疗方案。. Patients were randomized to receive GC only or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy or trilaciclib administered the day prior to and the day of chemotherapy. Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of ORR, PFS和操作系统.
Topline OS improvements were statistically significant in both trilaciclib arms compared with the control arm. ORR和PFS数据与SABCS 2018年发表的结果一致. The safety and tolerability of trilaciclib were consistent with previously reported data and there have been no serious adverse events attributed to treatment with trilaciclib in this trial.
Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. G1希望提交在美国的市场推广申请.S. 以及欧洲在2020年对小细胞肺癌进行骨髓保留治疗. 在一项针对转移性三阴性乳腺癌女性的随机试验中, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to initiate additional randomized trials to evaluate the myelopreservation and survival benefits of trilaciclib in other tumor types and chemotherapy regimens.
G1疗法公司. 一家处于临床阶段的生物制药公司是否专注于这一发现, development and delivery of innovative therapies that improve the lives of those affected by cancer. 公司正在推进三个临床阶段的项目. Trilaciclib is a first-in-class myelopreservation agent designed to improve outcomes for patients being treated with chemotherapy. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies. G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. G1也有一个活跃的发现计划，专注于周期蛋白依赖的激酶靶标.
G1的总部位于N.C. 更多信息，请访问 www.g1therapeutics.com 并在推特上关注彩乐园2@G1Therapeutics.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 比如“可能”,”“会,”“希望,”“计划,”“预测,”“估计,” “intend” and similar expressions (as well as other words or expressions referencing future events, 条件或环境)的目的是确定前瞻性陈述. 本彩乐园2稿中的前瞻性声明包括, 但不限于, 三叶草的治疗潜力, lerociclib and G1T48 and the timing for next steps with regard to the trilaciclib marketing applications, and are based on the Company’s expectations and assumptions as of the date of this press release. 每一种前瞻性陈述都涉及风险和不确定性. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company’s filings with the U.S. 美国证券交易委员会, 包括其中的“风险因素”部分，并包括, 但不限于, 本公司具备完成临床试验的能力, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; the Company’s development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; and market conditions. 法律规定的除外, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, 即使有了新的信息.