A Phase 3, Multicenter, Open-Label, Randomized Study of ELVN-001 Versus Investigator-Selected Tyrosine Kinase Inhibitor (TKI) of Dasatinib, Nilotinib, or Bosutinib, in Adult Participants With Chronic Myeloid Leukemia in Chronic Phase (CP-CML), Previously Treated With One or More TKIs

The study is designed to compare the efficacy of ELVN-001 versus Investigator-selected tyrosine kinase inhibitor (TKI) for adults with previously treated chronic myeloid leukemia in the chronic phase (CP-CML). The Investigator-selected TKI will be one of the following standard of care therapies: Dasatinib, Nilotinib, or Bosutinib.

开始日期2026-12-31

申办/合作机构

Enliven Therapeutics, Inc.

CTR20252548

/ Completed临床1期

一项在中国健康受试者中评价ELVN-001单次口服给药后的安全性、耐受性和药代动力学特征的随机、双盲、安慰剂对照、剂量递增的Ⅰ期临床研究

主要目的：评估中国健康受试者单次口服ELVN-001的安全性和耐受性。次要目的：评估中国健康受试者血浆中ELVN-001的PK特征。

开始日期2025-07-24

申办/合作机构

Enliven Therapeutics, Inc.

[+2]

100 项与 Relcobatinib 相关的临床结果

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100 项与 Relcobatinib 相关的转化医学

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100 项与 Relcobatinib 相关的专利（医药）

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项与 Relcobatinib 相关的文献（医药）

Blood Cancer Journal

Chronic myeloid leukemia: incorporation of recent advances into current treatment algorithms

Review

作者: Haddad, Fadi G ; Kantarjian, Hagop

Abstract:

Several approved and investigational BCR::ABL1 tyrosine kinase inhibitors (TKIs) and STAMP inhibitors are used for the treatment of chronic myeloid leukemia in chronic phase (CML-CP). In the frontline setting, multiple factors affect selection of therapy including the goal of treatment, cost of TKIs, CML risk, and patient’s comorbidities. Achieving a complete cytogenetic response ( BCR::ABL1 transcripts on the International Scale [IS] <1%) with TKI therapy within the first year is associated with normalization of survival, whereas achieving a deeper molecular response ( BCR::ABL1 transcripts < 0.01% [IS]) may allow for treatment discontinuation with the possibility of treatment-free remission. Although standard doses are approved for each TKI, post approval studies have demonstrated that an optimal biologic dose is safer than and as effective as the approved dose. In cases of TKI toxicities, reducing the dose rather than switching TKIs is recommended unless the patient experiences a prohibitive toxicity, in which case the treatment should be changed. In patients experiencing failure of frontline therapy due to resistance or intolerance, multiple second- and third-line options are available, including second-generation TKIs, ponatinib, and asciminib, as well as novel investigational agents, including the ABL1 kinase domain inhibitors olverembatinib and ELVN-001 and the STAMP inhibitors TGRX-678 and TERN-701. In this review, we discuss the recent advances in the treatment of CML-CP and challenge some established management practices.

项与 Relcobatinib 相关的新闻（医药）

2026-10-14

·PRNewswire

Enliven Therapeutics Appoints Kristine Ball to Board of Directors Ahead of Planned Phase 3 Trial Initiation this Year

Accomplished biopharmaceutical executive with extensive experience in corporate strategy, finance and commercial readiness Enliven continues preparation for late-stage development and commercialization, as it plans to initiate the pivotal Phase 3 trial of relcobatinib before year-end BURLINGAME, Calif., Oct. 14, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced the appointment of Kristine Ball to its Board of Directors, effective immediately. Ms. Ball brings more than 20 years of executive experience across clinical-stage and commercial-stage biopharmaceutical companies. "We are pleased to welcome Kristine Ball to our Board," said Rick Fair, Chief Executive Officer of Enliven. "Her experience helping companies transition from clinical development to commercial operations will bring valuable perspective as we prepare to initiate our pivotal Phase 3 trial of relcobatinib before year-end and plan for commercialization. We look forward to her contributions as we work to deliver a differentiated treatment option for people living with chronic myeloid leukemia and create long-term value for our shareholders." "Having seen the impact of CML on a member of my family, I feel a personal connection to Enliven's mission of helping people with CML not only live longer, but live better," said Ms. Ball. "I'm excited to contribute as the Company navigates this transition and prepares for potential commercialization. I look forward to working with the Board and leadership team to help advance relcobatinib through pivotal development and prepare Enliven for its next stage of growth." Ms. Ball brings extensive executive leadership and financial expertise in the biotechnology industry. Her experience spans corporate strategy, financing, commercial readiness and corporate governance. She has served as Chief Executive Officer of Antiva Biosciences; Chief Executive Officer of Soteria Biotherapeutics; Senior Vice President of Corporate Strategy and Chief Financial Officer of Menlo Therapeutics; and Senior Vice President and Chief Financial Officer of Relypsa, where she helped guide the company's transition from clinical development to commercial operations. Additionally, she serves on the Board of Directors of Oruka Therapeutics, where she chairs the Audit Committee. She previously served on the boards of Atreca and Forty Seven. Ms. Ball earned a Bachelor of Science from Babson College. Following its recent announcement of FDA alignment on the final design of ENABLE-2, Enliven remains focused on initiating the pivotal Phase 3 trial of relcobatinib (ELVN-001) in patients with previously treated chronic myeloid leukemia (CML) before year-end 2026. About Enliven Therapeutics Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California. To learn more, visit and connect with us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential of, and plans regarding, market opportunities, commercial readiness, potential commercialization, and expectations regarding relcobatinib (ELVN-001); statements regarding the potential differentiated attributes and therapeutic benefit of relcobatinib; the continued conduct, design and future clinical evaluation of relcobatinib, including the planned ENABLE-2 Phase 3 trial and the potential timing of initiation of ENABLE-2; expectations regarding the Company's growth, transition to late-stage development and commercialization, and the creation of long-term shareholder value; and statements by Enliven's Chief Executive Officer and a member of Enliven's Board of Directors. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation the limited operating history of Enliven; relcobatinib failing to demonstrate sufficient safety, efficacy, tolerability, durability, differentiated attributes or therapeutic benefit in current or future clinical trials; delays or difficulties in recruiting, enrolling or maintaining patients in relcobatinib clinical trials; the risks of delays in completing the ongoing ENABLE trial or initiating ENABLE-2; Enliven failing to complete the ongoing ENABLE trial, to initiate ENABLE-2 or to advance relcobatinib through clinical development; regulatory authorities disagreeing with Enliven's clinical trial design, endpoints or interpretation of data, or requiring additional studies or diagnostics; developments relating to Enliven's competitors and industry which may affect the development or potential market opportunity for relcobatinib; and the potential inability of Enliven to obtain regulatory approval for, or ultimately commercialize or license, relcobatinib or other product candidates; Enliven's limited resources; Enliven's limited experience as a company in designing and conducting clinical trials; Enliven's lack of commercialization expertise; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geopolitical developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and Form 10-Q filed with the SEC and in Enliven's future SEC filings. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. SOURCE Enliven Therapeutics, Inc. 21% more press release views with Request a Demo

高管变更临床3期

2026-10-06

·临研云

临研云日报 2026-10-07｜epcoritamab 联合 R-CHOP 一线 DLBCL III 期达标：进展或死亡风险降

临研云日报第 18 期 · 2026-10-07 今日观察双抗联合 R-CHOP 改写一线 DLBCL ｜原研药出海 BICR 评估成关键变量｜罕见病已上市资产成并购硬通货｜欧洲生科风投逆势创纪录 01 【临床试验】epcoritamab 联合 R-CHOP 一线 DLBCL III 期达标：进展或死亡风险降低 51% 图：Retired electrician / CC0 10 月 5 日，艾伯维与 Genmab 宣布全球 III 期 EPCORE DLBCL-2（NCT05578976）达到主要终点。新诊断弥漫性大 B 细胞淋巴瘤（IPI 2 至 5）患者按 2:1 随机接受 epcoritamab 联合 R-CHOP 或 R-CHOP，均为 6 周期后再用 2 周期单药巩固。主要终点人群（IPI 3 至 5）疾病进展或死亡风险降低 51%（HR 0.49，95% CI 0.35 至 0.69，p<0.0001）；全人群 PFS 的 HR 为 0.49（95% CI 0.36 至 0.67）。安全性与两药已知特征一致。两家公司将与全球监管机构沟通下一步，数据将在后续医学会议公布。行业影响：这是首个在一线 DLBCL 证明 PFS 显著获益的双特异性抗体联合方案，R-CHOP 作为 20 余年一线标准的地位可能被改写；国内多家 CD20xCD3 双抗同类品种的一线布局将被倒逼加速。合作机会：一线 DLBCL 大型随机研究将增多，血液肿瘤中心的入组与中心实验室 PET/CT 评估需求上升；双抗 CRS 管理培训与真实世界数据服务也将随之扩张。来源：AbbVie · 2026-10-05 02 【中国创新】艾力斯伏美替尼全球 III 期 FURVENT 一线 EGFR 20 外显子插入 NSCLC 未达 PFS 主要终点图：Chen CL, Chen CC, Yu WH, Chen SH, Chang YC, Hsu TI / CC BY 4.0 10 月 6 日，ArriVent 公布与艾力斯合作开发的伏美替尼（firmonertinib）全球 III 期 FURVENT 结果。研究全球入组 398 例初治 EGFR 20 外显子插入突变非鳞 NSCLC 患者，分为 240 mg、160 mg 和培美曲塞联合铂类化疗三组。盲态独立中心评估（BICR）中位 PFS 分别为 11.0 个月、8.4 个月和 9.5 个月，240 mg 组 HR 0.75（95% CI 0.55 至 1.02，p=0.0654），未达显著；研究者评估中位 PFS 为 11.1 个月对 7.1 个月（HR 0.61）。3 级及以上治疗相关不良事件 26%、22%、40%。行业影响：伏美替尼已在中国获批经典 EGFR 突变及经治 20 外显子插入适应症，并获 FDA 一线突破性疗法认定；此次 BICR 与研究者评估结论分歧，提醒中国原研药出海时影像评估标准化的重要性。合作机会：全球多中心试验的独立影像评审（BICR）质量管理与阅片一致性培训需求上升；EGFR 20 外显子插入人群的入组筛查与检测服务仍是稀缺资源。来源：ArriVent BioPharma · 2026-10-06 03 【全球视野】盐野义 20 亿美元收购 IntraBio，获罕见神经病药物 AQNEURSA 及管线图：Tokumeigakarinoaoshima / CC BY-SA 4.0 10 月 5 日，盐野义制药宣布以 20 亿美元对价收购美国罕见病公司 IntraBio，预计 2026 年 11 月至 12 月完成交割。核心资产 AQNEURSA（levacetylleucine）已于 2024 年 9 月获 FDA 批准、2026 年 1 月获 EMA 批准用于 C 型尼曼匹克病神经症状，并于 2026 年 9 月 18 日获 FDA 批准用于共济失调毛细血管扩张症患者的共济失调，欧洲审评进行中。IntraBio 2025 财年净销售额 6790 万美元、净亏损 3580 万美元；交易同时带来庞贝病、脆性 X 综合征、Jordan 综合征等开发项目。盐野义此前已于 2026 年 4 月收购依达拉奉资产。行业影响：日本药企正以已上市罕见病资产快速补齐全球产品线，带有 FDA 和 EMA 双批准的小适应症产品成为高溢价并购标的；中国罕见病药企可据此定位自身资产价值。合作机会：罕见神经病适应症在中国的桥接试验与注册申报需求上升；患者登记、自然病史研究与中心化神经功能评估服务的机会增加。来源：Shionogi · 2026-10-05 04 【医药合作】礼来扩大与 Gate Bioscience 合作，新增靶点潜在总额超 8.7 亿美元图：Momoneymoproblemz / CC BY-SA 4.0 10 月 5 日，Gate Bioscience 宣布与礼来扩大 2025 年签署的合作与许可协议，利用其 Molecular Gate 药物发现引擎针对难成药的胞外蛋白设计分子门控药物。本次扩展新增 1 个未披露靶点，并保留增加第 2 个靶点的选择权，潜在总额超过 8.7 亿美元；Gate 将获得首付款、选定第二靶点时的后续付款、研究经费，以及临床前、临床和商业化里程碑与分级销售提成。Gate 负责发现阶段，礼来负责后期临床前、临床开发、生产与商业化并获得全球独家许可。双方 2025 年 7 月首次签署的协议潜在价值最高 8.56 亿美元；Gate 称其平台已识别约 4000 个潜在靶点，覆盖免疫、神经和心血管代谢领域。行业影响：大型药企持续用平台型合作锁定新作用机制，难成药胞外蛋白领域从概念验证走向多靶点扩展；中国平台型公司可参考这类分阶段付款结构。合作机会：分子门控等新模态进入临床后，首次人体试验的 PK 和生物标志物检测需求上升；国内具备新模态经验的 I 期中心可提前对接。来源：Gate Bioscience · 2026-10-05 05 【监管动态】Enliven 与 FDA 就 relcobatinib 经治 CML III 期设计达成一致，450 例头对头图：Paulo Henrique Orlandi Mourao / CC BY-SA 3.0 10 月 6 日，Enliven Therapeutics 宣布已与 FDA 就 relcobatinib（ELVN-001）关键 III 期 ENABLE-2 的最终设计达成一致。研究计划入组约 450 例既往接受过至少一种酪氨酸激酶抑制剂治疗的慢性髓性白血病成人患者，按 1:1 随机接受 relcobatinib 80 mg 每日一次，或研究者选择的二代 TKI（达沙替尼、尼洛替尼或博舒替尼）。主要终点为第 24 周主要分子学缓解（MMR），关键次要终点为第 96 周 MMR；MMR 率较对照组提高至少 10 个百分点即可证明统计学优效。研究预计 2026 年底前启动。行业影响：FDA 认可以 24 周 MMR 为主要终点、以 10 个百分点为优效界值的头对头设计，为后续 BTK/ABL 等靶点的经治人群注册研究提供了可参照的方案框架。合作机会：CML 头对头随机研究对分子学检测（BCR::ABL1 国际标准化定量）的中心实验室需求上升；国内血液中心可争取参与全球入组。来源：Enliven Therapeutics · 2026-10-06 06 【行业趋势】Forbion 两只新基金募资 23 亿欧元，拟投约 30 家生物科技公司图：Nederlands Vestingmuseum / CC BY-SA 4.0 10 月 6 日，欧洲生命科学风险投资机构 Forbion 宣布完成总额 23 亿欧元（约 26 亿美元）的募资，为其成立以来规模最大的一次，资金分属 Forbion Growth Opportunities Fund IV（面向欧洲和北美后期生物制药公司）和 Forbion Ventures Fund VIII（面向治疗类生物科技公司），两只基金合计可为约 30 家公司提供融资，首批投资已完成。出资方包括 MN、PGGM、KfW Capital、考夫曼基金会及礼来。Forbion 管理资产规模约 75 亿欧元，成立以来累计投资 142 家公司，支持 21 款获批医疗产品上市。行业影响：在整体融资偏紧的环境下，头部机构仍能超额完成募资，说明资金正向有临床数据支撑的项目集中；欧洲后期生物制药公司将获得更充足的 II/III 期资金。合作机会：获投公司启动国际多中心试验的节奏将加快，中国 CRO 与研究中心可争取欧洲项目的亚洲入组份额；跨境临床运营与注册咨询需求上升。来源：Forbion · 2026-10-06 每天一期，每条都挂了库内相关试验直达。点文末「阅读原文」看网页版（可翻历史全部期次）：https://trials.wisesoul.com.cn/news/daily/2026-10-07

临床3期突破性疗法并购临床结果

2026-10-06

·动脉网

Enliven Therapeutics宣布美国食品药品监督管理局（FDA）就 relcobatinib（ELVN-001）治疗既往接受过治疗的慢性髓性白血病的 ENABLE-2 III期临床试验设计达成一致Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia

Enliven remains on track to initiate ENABLE-2 before year-end 2026 Enliven 仍按计划于 2026 年底前启动 ENABLE-2BURLINGAME, Calif. 加利福尼亚州伯灵格姆, ，Oct. 6, 2026 2026年10月6日/PRNewswire/ -- /美通社/ --Enliven Therapeutics, Inc. Enliven Therapeutics, Inc.(Enliven or the Company) (Nasdaq: (Enliven 或该公司) (纳斯达克：ELVN ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial, a Phase 3 trial of relcobatinib (ELVN-001) in patients with previously treated chronic myeloid leukemia (CML).. ），一家专注于小分子疗法发现与开发的临床阶段生物制药公司，今日宣布其已就ENABLE-2关键性试验的最终设计方案与美国食品药品监督管理局（FDA）达成一致。ENABLE-2是一项3期临床试验，旨在评估relcobatinib（ELVN-001）在既往接受过治疗的慢性髓性白血病（CML）患者中的疗效。United States Adopted Names (USAN) Council has adopted relcobatinib as the nonproprietary name for ELVN-001. Relcobatinib is an investigational, potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver of CML.. 美国采用名称（USAN）委员会已采纳 relcobatinib 作为 ELVN-001 的非专有名称。Relcobatinib 是一种在研的强效、高选择性、潜在同类最佳的小分子激酶抑制剂，旨在特异性靶向 BCR::ABL1 基因融合，该融合基因是慢性髓性白血病（CML）的致癌驱动因子。'We are pleased to have reached alignment with the FDA on the design of the ENABLE-2 pivotal Phase 3 trial, providing a clear path to initiate the trial before year-end,' said Helen Collins, M.D., Chief Medical Officer of Enliven. 'ENABLE-2 is designed to directly compare relcobatinib to the second-generation TKIs and evaluate its potential to be the best-in-class ATP-competitive inhibitor for patients with CML. Enliven首席医学官Helen Collins博士表示：“我们很高兴已与FDA就ENABLE-2关键性III期临床试验的设计达成一致，为在年底前启动该试验提供了清晰的路径。ENABLE-2旨在直接比较relcobatinib与第二代酪氨酸激酶抑制剂（TKIs），并评估其成为慢性髓性白血病（CML）患者同类最佳ATP竞争性抑制剂的潜力。”We are encouraged by the enthusiasm from physicians and the broader CML community as we prepare to initiate the trial.'. 在准备启动该试验之际，我们受到来自医生和更广泛的慢性髓性白血病（CML）社群的热情鼓舞。ENABLE-2 Phase 3 Trial Design: A 2L+ Pivotal Trial for Patients with CML ENABLE-2 三期临床试验设计：一项针对慢性髓性白血病（CML）患者的二线及以上关键性试验ENABLE-2 is a planned randomized 2L+ phase 3 trial expected to enroll approximately 450 adults with CML previously treated with one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib). ENABLE-2 是一项计划中的随机、二线及以上（2L+）三期临床试验，预计招募约 450 名既往接受过一种或多种酪氨酸激酶抑制剂（TKI）治疗的慢性髓性白血病（CML）成人患者。参与者将以 1:1 的比例随机分配，接受每日一次 80 mg 的 relcobatinib 或由研究者选择的第二代 TKI（达沙替尼、尼洛替尼或博舒替尼）治疗。The primary endpoint is major molecular response (MMR) at Week 24, with the key secondary endpoint of MMR at Week 96.. 主要终点为第24周时的主要分子学反应（MMR），关键次要终点为第96周时的主要分子学反应（MMR）。With approximately 450 patients, the trial is designed such that an improvement in MMR rate of at least 10 percentage points over the control arm would be sufficient to demonstrate statistical superiority. We believe this difference would represent a clinically meaningful improvement over currently available second-generation TKIs.. 该试验纳入约450名患者，其设计使得主要分子学反应（MMR）率较对照组提高至少10个百分点即足以证明统计学上的优效性。我们认为，这一差异代表相较于目前可用的第二代酪氨酸激酶抑制剂（TKIs）具有临床意义的改善。The Company remains on track to initiate ENABLE-2 before year-end 2026. 公司仍按计划于2026年底前启动ENABLE-2研究。About Enliven Therapeutics 关于 Enliven TherapeuticsEnliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven 是一家处于临床阶段的生物制药公司，专注于小分子疗法的发现与开发，旨在帮助人们不仅活得更长久，而且活得更有质量。Enliven 致力于通过精准医疗方法解决现有及新兴的未满足需求，从而提高生存率并提升整体福祉。Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California. To learn more, visit . Enliven的发现流程结合了对经临床验证的生物靶点的深入洞察以及差异化的化学技术，旨在设计潜在的同类首创或同类最优疗法。Enliven总部位于加利福尼亚州伯林盖姆。欲了解更多信息，请访问。www.enliventherapeutics.com www.enliventherapeutics.comand connect with us on 并在以下平台关注我们LinkedIn 领英and 和X X. 。Forward-Looking Statements 前瞻性陈述This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. 本新闻稿包含涉及重大风险和不确定性的前瞻性陈述（包括经修订的《1934年证券交易法》第21E条和经修订的《1933年证券法》第27A条所定义的前瞻性陈述），内容涉及Enliven及其他事项。这些陈述可能基于Enliven管理层当前的信念以及管理层所作的假设和目前掌握的信息，讨论有关未来计划、趋势、事件、经营业绩和财务状况等方面的目标、意图和预期。Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as 'may,' 'will,' 'should,' 'would,' 'expect,' 'anticipate,' 'plan,' 'likely,' 'believe,' 'estimate,' 'project,' 'intend,' and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. 前瞻性陈述通常包括具有预测性质的陈述，其依赖于或提及未来事件或条件，并包含“可能”、“将”、“应该”、“会”、“预期”、“预计”、“计划”、“很可能”、“相信”、“估计”、“规划”、“打算”等词语，以及这些词语的否定形式、复数形式或其他类似表述，或虽未包含上述词语但属于预测性质或指示未来事件或前景的其他类似表述，尽管并非所有前瞻性陈述均包含这些词语。Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding relcobatinib (ELVN-001); statements regarding the potential profile, activity, selectivity, safety, tolerability, efficacy, differentiated attributes, therapeutic benefit and potential best-in-class or complementary profile of relcobatinib to allosteric inhibitors; the interpretation of data from the ongoing ENABLE trial, including MMR rate, safety and tolerability data; comparisons to historical or precedent clin. 非历史事实的陈述属于前瞻性陈述。本新闻稿中的前瞻性陈述包括但不限于：有关市场机会的潜力及相关计划，以及对relcobatinib（ELVN-001）的预期；有关relcobatinib作为变构抑制剂的潜在特征、活性、选择性、安全性、耐受性、疗效、差异化属性、治疗获益以及潜在的同类最佳或互补特征的陈述；对正在进行的ENABLE试验数据的解读，包括主要分子缓解率（MMR）、安全性和耐受性数据；与历史或先例临床This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. 本新闻稿包含超链接，指向不被视为通过引用纳入本新闻稿的信息。SOURCE Enliven Therapeutics, Inc. 来源：Enliven Therapeutics, Inc.21 二十一% %more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示

100 项与 Relcobatinib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
慢性期慢性髓性白血病	临床3期	-	Enliven Therapeutics, Inc.	2026-12-31
费城染色体阳性慢性粒细胞白血病	临床3期	-	Enliven Therapeutics, Inc.	2026-12-31
慢性粒细胞性白血病	临床1期	中国	Enliven Therapeutics, Inc.	2025-07-24

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05304377 (ENABLE, Company_Website) 人工标引	临床1期	慢性粒细胞性白血病	60	ELVN-001 80 mg QD	廠醖餘製構憲夢醖艱蓋(選範醖窪網構窪醖選夢) = 網餘構構淵觸艱選壓構遞齋繭鹹廠遞壓窪鹹衊 (鹹淵膚窪願網繭憲簾壓 ) 更多	积极	2026-01-08
				ELVN-001 60/120 mg QD	廠醖餘製構憲夢醖艱蓋(選範醖窪網構窪醖選夢) = 壓衊齋壓廠製積鏇網蓋遞齋繭鹹廠遞壓窪鹹衊 (鹹淵膚窪願網繭憲簾壓 ) 更多
NCT05304377 (ENABLE, ASH2025)	临床1期	慢性期慢性髓性白血病	6	ELVN-001 (CML with atypical fusion transcripts)	築夢壓膚鬱鏇衊簾願製(齋廠蓋觸觸餘積選構淵) = One patient with e13a3 was enrolled. The patient received ELVN-001 at 80 mg QD (224 days on study), achieved a > 1 log decrease in transcript and has not experienced any TEAEs. One patient with e13a3 transcript and T315I/S348L mutations was enrolled. The patient received ELVN-001 at 120 mg QD (449 days on study), had a decrease in transcript from 0.95% to 0.15% and has not experienced any TEAE >G2. One patient with e19a2 transcript and a T315I mutation was enrolled. The patient received ELVN-001 at 80 mg QD with dose escalation to 120 mg QD (505 days on study), achieved a >1 log decrease in transcript and has not experienced any TEAE >G2. One patient with e1a3 transcript was enrolled. The patient received ELVN-001 at 80 mg BID (80 days on study), had a decrease in transcript from 43% to 18% and has not experienced any TEAE >G2. Two patients with e1a2 transcript were enrolled. Both patients had no baseline transcript available and are therefore not efficacy evaluable. However, on study, transcripts remained stable. One patient discontinued prior bosutinib and dasatinib due to lack of efficacy, received ELVN-001 at 120 mg QD (176 days on study) and has not experienced any TEAE >G2. Another patient discontinued prior imatinib, radotinib and dasatinib due to lack of efficacy, received ELVN-001 at 20 mg QD with dose escalation up to 120 mg QD (537 days on study) and has not experienced any TEAE >G2. 簾範糧範窪鏇壓鹽壓願 (獵鹽顧憲鹽製遞顧構蓋 )	积极	2025-12-06
PRNewswire 人工标引	临床1期	慢性粒细胞性白血病	53	ELVN-001	蓋壓顧獵網艱鑰蓋窪鹽(餘鏇繭艱製夢醖鏇願壓) = 淵壓網觸艱構獵鏇襯願廠積鬱糧網齋獵膚淵獵 (淵鹹淵憲衊鑰構網膚艱 ) 更多	积极	2025-06-13
				ELVN-001 (resistant to their last TKI)	蓋壓顧獵網艱鑰蓋窪鹽(餘鏇繭艱製夢醖鏇願壓) = 膚壓窪廠築齋鏇選鬱夢廠積鬱糧網齋獵膚淵獵 (淵鹹淵憲衊鑰構網膚艱 )
NCT05304377 (ENABLE, EHA2025)	临床1期	慢性期慢性髓性白血病 BCR::ABL1 T315I mutation	74	ELVN-001	觸積夢醖衊構醖獵積窪(顧遞鏇廠簾膚淵衊鏇淵) = Grade ≥3 TEAEs were reported in 11/72 (15%) patients, with thrombocytopenia (5.6%) and neutropenia (5.6%) most commonly reported 壓顧獵築鏇願積襯膚襯 (廠淵鬱壓製築窪蓋膚積 ) 更多	积极	2025-05-14
NCT05304377 (GlobeNewswire) 人工标引	临床1期	慢性粒细胞性白血病	39	ELVN-001	糧製艱願簾鏇醖選醖獵(積憲淵選膚鏇餘範鹹襯) = 簾觸壓簾網鹹製膚範淵醖餘遞衊繭鹹網積積齋 (膚艱廠憲淵鑰願範積構 )	积极	2024-09-28
				ELVN-001 (TKI-resistant)	糧製艱願簾鏇醖選醖獵(積憲淵選膚鏇餘範鹹襯) = 糧憲醖壓鬱窪製鑰製夢醖餘遞衊繭鹹網積積齋 (膚艱廠憲淵鑰願範積構 )
NCT05304377 (GlobeNewswire) 人工标引	临床1期	费城染色体阳性慢性粒细胞白血病 BCR-ABL1 Fusion	27	ELVN-001	齋繭襯鑰膚廠窪壓顧繭(壓鏇製襯齋憲衊製襯鏇) = No ≥ Grade 3 non-hematologic treatment-related adverse events (TRAE) and no specific non-hematologic TRAE of any grade occurred in >11% of patients. 淵繭窪淵齋構顧鑰網醖 (襯構築窪糧範範齋窪廠 ) 更多	积极	2024-04-11
				ELVN-001 (prior exposure to asciminib)