BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced further details for its late-breaking presentation of mature data from the ongoing Phase 2 RAMP 201 (ENGOT-ov60/GOG-3052) clinical trial to be presented as an oral presentation at a plenary session at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting taking place October 16-18, 2024 in Dublin, Ireland..

波士顿--（商业新闻短讯）--致力于为癌症患者开发新药的生物制药公司Verastem Oncology（Nasdaq:VSTM）今天宣布了其最新发布的第二阶段RAMP 201（ENGOT-ov60/GOG-3052）临床试验成熟数据的进一步细节，该试验将于2024年10月16日至18日在爱尔兰都柏林举行的国际妇科癌症协会（IGCS）全球年会的全体会议上以口头形式提交。。

The late-breaking abstract is embargoed until the morning of the presentation at IGCS. The oral presentation will include updated safety and efficacy data from the RAMP 201 trial evaluating the combination of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral, selective FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC), including overall response rate, progression free survival, and duration of response..

最新发布的摘要将被禁止发布，直到IGCS的演示早上。口头报告将包括RAMP 201试验的最新安全性和有效性数据，该试验评估了口服RAF/MEK钳avutometinib和口服选择性FAK抑制剂defactinib在复发性低度浆液性卵巢癌（LGSOC）患者中的组合，包括总有效率，无进展生存期和反应持续时间。。

Title: Efficacy and Safety of Avutometinib + Defactinib in Recurrent Low Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-ov60/GOG-3052/RAMP 201

标题：Avutometinib+Defactinib治疗复发性低度浆液性卵巢癌的疗效和安全性：ENGOT-ov60/GOG-3052/RAMP 201的初步分析

Date/Time: October 17, 2024, at 11:42 AM ET/4:42 PM Irish time [GMT +1].

日期/时间：2024年10月17日，美国东部时间上午11:42/爱尔兰时间下午4:42[GMT+1]。

Presenter: Professor Susana N. Banerjee, MBBS, MA PhD, FRCP, global lead investigator of the study, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Team Leader in Women’s Cancers at The Institute of Cancer Research, London

主持人：Susana N.Banerjee教授，MBBS，MA博士，FRCP，该研究的全球首席研究员，皇家马斯登NHS基金会信托基金的顾问医学肿瘤学家，伦敦癌症研究所女性癌症团队负责人

Verastem will hold an investor conference call and webcast on October 17, 2024 at 4:30 p.m. EDT, to review the mature data from the RAMP 201 trial. To access the conference call, please dial (844) 763-8274 (local) or (412) 717-9224 (international) at least 10 minutes prior to the start time and ask to be joined into the Verastem Oncology conference call.

Verastem将于2024年10月17日美国东部夏令时下午4:30举行投资者电话会议和网络广播，审查RAMP 201试验的成熟数据。要访问电话会议，请在开始时间前至少10分钟拨打（844）763-8274（本地）或（412）717-9224（国际），并要求加入Verastem肿瘤学电话会议。

A live audio webcast of the call, along with accompanying slides, will be accessible under “Events & Presentations” in the Investors & Media section of the company’s website at www.verastem.com..

电话的实时音频网络广播以及随附的幻灯片将在公司网站www.verastem.com的投资者与媒体部分的“活动与演示”下进行。。

About the Avutometinib and Defactinib Combination

关于Avutometinib和Defactinib的组合

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK.

Avutometinib是一种RAF/MEK钳，可诱导MEK与ARAF，BRAF和CRAF的无活性复合物，可能通过最大的RAS/MAPK途径抑制产生更完整和持久的抗肿瘤反应。与目前可用的仅MEK抑制剂相反，avutometinib阻断MEK激酶活性和RAF磷酸化MEK的能力。

This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other MEK-only inhibitors..

这种独特的机制允许avutometinib阻断MEK信号传导，而不需要MEK的补偿性激活，这似乎限制了其他仅MEK抑制剂的功效。。

Verastem Oncology is currently conducting clinical trials with avutometinib in RAS/MAPK driven tumors as part of its Raf And Mek Program or RAMP. Verastem is currently enrolling patients and activating sites for RAMP 301 (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib, a selective FAK inhibitor, versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC).

Verastem Oncology目前正在RAS/MAPK驱动的肿瘤中使用avutometinib进行临床试验，作为其Raf和Mek计划或RAMP的一部分。Verastem目前正在招募RAMP 301（NCT06072781）的患者和激活位点，这是一项国际3期验证性试验，评估avutometinib和defactinib（一种选择性FAK抑制剂）与标准化疗或激素治疗联合治疗复发性低度浆液性卵巢癌（LGSOC）。

RAMP 201 (NCT04625270) is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and enrollment has been completed for the entire RAMP 201 trial, including regimen selection and expansion of the go forward regimen..

RAMP 201（NCT04625270）是avutometinib联合defactinib治疗复发性LGSOC患者的2期登记指导试验，整个RAMP 201试验的登记已经完成，包括方案选择和前进方案的扩展。。

Verastem initiated a rolling New Drug Application (NDA) submission in May 2024 to the U.S. Food and Drug Administration (FDA) for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who received at least one prior systemic therapy and expects to complete its NDA submission in the second half of 2024 with a potential FDA decision in the first half of 2025.

Verastem于2024年5月向美国食品和药物管理局（FDA）提交了一份滚动新药申请（NDA），用于研究avutometinib和defactinib在复发性KRAS突变LGSOC患者中的联合应用，这些患者至少接受过一次全身治疗，预计在2024年下半年完成NDA提交，并在2025年上半年做出FDA的潜在决定。

The FDA granted Breakthrough Therapy Designation of the investigational combination of avutometinib and defactinib for the treatment of all patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC..

FDA批准了avutometinib和defactinib研究组合的突破性治疗指定，用于治疗一种或多种先前治疗方案（包括铂类化疗）后所有复发性LGSOC患者。。。

Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS™ (sotorasib) in combination with avutometinib and defactinib and KRAZATI™ (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials, respectively.

作为RAMP 203（NCT05074810）和RAMP 204（NCT05375994）试验的一部分，Verastem Oncology与Amgen和Mirati建立了临床合作，以评估LUMAKRAS™（sotorasib）联合avutometinib和defactinib以及KRAZATI™（adagrasib）联合avutometinib治疗KRAS G12C突变NSCLC。

The RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to avutometinib and defactinib combination for the treatment of pancreatic cancer..

RAMP 205（NCT05669482）是一项1b/2期临床试验，评估阿维替尼和defactinib与吉西他滨/纳布紫杉醇联合治疗一线转移性胰腺癌患者，得到了PanCAN治疗加速器奖的支持。美国食品和药物管理局（FDA）将孤儿药命名为avutometinib和defactinib联合治疗胰腺癌。。

About Verastem Oncology

关于真性肿瘤学

Verastem Oncology (Nasdaq: VSTM) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on RAS/MAPK-driven cancers, specifically novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and FAK inhibition.

Verastem Oncology（纳斯达克：VSTM）是一家晚期开发生物制药公司，致力于新药的开发和商业化，以改善被诊断患有癌症的患者的生活。我们的管道专注于RAS/MAPK驱动的癌症，特别是抑制癌症中促进癌细胞存活和肿瘤生长的关键信号传导途径的新型小分子药物，包括RAF/MEK抑制和FAK抑制。