Immuneering 拟启动 atebimetinib 联合化疗治未分化甲状腺癌二期试验：约60人，2027年中首例给药
在纽约上市的肿瘤药公司 Immuneering（Nasdaq: IMRX）11 月 12 日宣布，计划启动一项 2 期临床试验，评估其口服药 atebimetinib 联合化疗治疗未分化甲状腺癌（ATC）的效果。未分化甲状腺癌是一种进展极快、侵袭性强的罕见甲状腺癌，常见由 BRAF 或 RAS 突变驱动，现有治疗选择有限。
按计划，公司拟在 2026 年底前向美国食品药品监管局（FDA）提交该项目的新药临床试验（IND）申请；获监管放行后，预计 2027 年年中为首例患者给药，给药后 12 至 18 个月可望获得顶线结果。试验初步计划招募约 60 名标准治疗后进展的 ATC 患者，包括一个不限突变状态的全人群队列和一个 BRAF V600E 队列，并按可成为注册性试验的方向设计，具体仍待与监管机构讨论。
支持该方案的临床前数据将于 11 月 18 日在西班牙 Barcelona 举行的第 38 届 EORTC-NCI-AACR 分子靶点与癌症治疗大会上以海报形式公布（摘要号 144，海报号 PB-144，报告人 Praveen Nair）。
纪念斯隆凯特琳癌症中心头颈肿瘤科主任 Alan Ho 表示，未分化甲状腺癌仍是最难应对的恶性肿瘤之一，肿瘤进展极快，许多患者治疗选择有限，需要能为更广泛患者带来持久疾病控制的新方法。Immuneering 首席执行官 Ben Zeskind 表示，atebimetinib 在胰腺癌中与化疗联用的结果增强了公司推进这一路径的信心。
atebimetinib 是一种每日口服一次的 MEK 深循环抑制剂，靶向在多数癌症中被异常激活的 MAPK 通路，公司正在胰腺癌一线治疗中推进其全球关键试验 MAPKeeper 301。需要说明的是，本项 ATC 试验尚处计划阶段，尚未开始招募，疗效与安全性均未确立。（来源：Immuneering）
Immuneering Plans Phase 2 Trial of Atebimetinib Plus Chemotherapy in Anaplastic Thyroid Cancer: About 60 Patients, First Dosing Targeted Mid-2027
Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company based in New York, announced on November 12 that it plans to initiate a Phase 2 clinical trial evaluating its oral drug atebimetinib in combination with chemotherapy in patients with anaplastic thyroid cancer (ATC), a rare and highly aggressive form of thyroid cancer commonly driven by BRAF or RAS mutations and with significant unmet need.
The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the program by the end of 2026. Subject to regulatory clearance, it expects to dose the first patient in mid-2027, with topline results potentially available 12 to 18 months after dosing begins. The preliminary plan is to enroll approximately 60 patients with ATC who progressed on standard of care, including an all-comers cohort and a BRAF V600E cohort. The study is designed to be potentially registrational, pending discussion with regulators.
Preclinical data supporting the rationale will be presented as a poster at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18-20, 2026, in Barcelona, Spain (Abstract 144, Poster PB-144, presenter Praveen Nair).
Alan Ho, M.D., Ph.D., Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center, said anaplastic thyroid cancer remains one of the most challenging malignancies, with tumors that can progress extraordinarily quickly and limited treatment options for many patients. Immuneering co-founder and CEO Ben Zeskind, Ph.D., said results seen to date with atebimetinib in combination with chemotherapy in pancreatic cancer reinforced the company's conviction in the approach.
Atebimetinib is a once-daily oral deep cyclic inhibitor of MEK, a key control point in the MAPK pathway, and the company is conducting the global pivotal MAPKeeper 301 trial of the drug with chemotherapy in first-line pancreatic cancer. The planned ATC trial has not yet begun enrolling, and the drug's safety and efficacy for this indication have not been established. (Source: Immuneering)
来源：Immuneering
发布：GSM·美国（发布链接）
图片来源：图：纪念斯隆凯特琳癌症中心位于纽约 First Avenue 的入口夜景；该中心头颈肿瘤科主任 Alan Ho 为本试验设计专家之一。Wikimedia Commons，CC BY-SA 4.0。 / Image: The Memorial Sloan Kettering Cancer Center entrance at night on First Avenue in New York; its head and neck oncology chief Alan Ho is among the experts who helped design the planned trial. Via Wikimedia Commons, CC BY-SA 4.0.
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