KRAKOW, Poland, December 07, 2025 / Biotech Newswire / --

波兰克拉科夫，2025年12月7日 /生物技术新闻社/ --

Ryvu Therapeutics

瑞维治疗学

(WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, is presenting new clinical results from the RIVER-81 and POTAMI-61 studies evaluating romaciclib (RVU120), a first-in-class selective CDK8/19 inhibitor, at the 2025 American Society of Hematology (ASH) Annual Meeting, December 6-10, 2025, in Orlando, Florida..

(RVU: WSE)，一家专注于肿瘤学新兴靶点的临床阶段药物发现与开发公司，将在2025年12月6日至10日于佛罗里达州奥兰多举行的2025年美国血液学会（ASH）年会上，展示来自RIVER-81和POTAMI-61研究的全新临床结果，评估其首创的CDK8/19选择性抑制剂romaciclib（RVU120）。

Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, said:

亨德里克·诺盖，医学博士，Ryvu Therapeutics首席医疗官表示：

'The updated romaciclib data presented at ASH 2025 strengthen our confidence in its broad therapeutic potential across hematologic cancers with limited treatment options. We are particularly encouraged by complete remissions in post-venetoclax relapsed/refractory AML, as well as early signs of meaningful reductions in spleen volume in patients with myelofibrosis.

“在2025年ASH上展示的更新的romaciclib数据增强了我们对其在治疗选择有限的血液癌症中广泛治疗潜力的信心。我们特别受到venetoclax复发/难治性AML患者完全缓解的鼓舞，同时也在骨髓纤维化患者中看到了脾脏体积显著减小的早期迹象。

These results support our belief that romaciclib can become an important component of future treatment strategies in AML and MF.'.

这些结果支持了我们的信念，即罗米西利布可以成为未来急性髓系白血病和骨髓纤维化治疗策略的重要组成部分。

Pau Montesinos, MD, PhD, Head of the Leukemia Unit of the Department of Hematology at the University Hospital La Fe in Valencia, Spain, said:

西班牙瓦伦西亚拉费大学医院血液科白血病部门负责人保罗·蒙特西诺斯医学博士、哲学博士说：

'Patients who have failed venetoclax-azacitidine treatment in AML need better therapeutic options. The clinical data generated with the romaciclib-venetoclax combination so far are promising and supportive of further investigation in this setting and should be confirmed in a larger group of patients.'.

“在AML中，对于维奈托克-阿扎胞苷治疗失败的患者，需要更好的治疗选择。迄今为止，罗米西利布与维奈托克联合使用的临床数据具有前景，并支持在此背景下进一步研究，且应在更大规模的患者群体中加以验证。”

Raajit K. Rampal, MD, PhD, Director, MPN and Rare Hematologic Diseases, Memorial Sloan Kettering Cancer Center, said:

纪念斯隆凯特琳癌症中心MPN和罕见血液疾病主任Raajit K. Rampal医学博士、哲学博士说：

'Romaciclib has shown clinically meaningful activity in patients with myelofibrosis. The reported data support further development of romaciclib and point to a potential path to approval.'

“Romaciclib 在骨髓纤维化患者中显示出具有临床意义的活性。所报告的数据支持进一步开发 romaciclib，并指出了一个潜在的获批路径。”

Ryvu will host a webinar to discuss data on RIVER-81 and POTAMI-61, December 7 at 5:30 PM CET:

Ryvu 将于 12 月 7 日下午 5 点 30 分（欧洲中部时间）举办网络研讨会，讨论 RIVER-81 和 POTAMI-61 的数据：

here

这里

Clinical updates from RIVER-81 and POTAMI-61 studies of

RIVER-81 和 POTAMI-61 研究的临床更新

romaciclib

瑞博西利

(RVU120):

(RVU120):

The posters will be showing data with a cut-off of September 22, 2025, but more recent data is available and is summarized below:

海报将展示截至2025年9月22日的数据，但更新的数据已提供，并总结如下：

Poster Title:

海报标题：

Preliminary results from

初步结果来自

RIVER-81

河流-81

, a phase 2 study of romaciclib (RVU120) + venetoclax in patients with acute myeloid leukemia failing first-line venetoclax + hypomethylating agent (HMA)

，一项关于罗米西利布（RVU120）+维奈托克在一线维奈托克+低甲基化剂（HMA）治疗失败的急性髓系白血病患者中的二期研究

Session name:

会话名称：

616. Acute myeloid leukemias: Investigational drug and cellular therapies: Poster 2

616. 急性髓系白血病：研究性药物和细胞疗法：海报2

Poster number:

海报编号：

3424

3424

The Phase II RIVER-81 study evaluates the combination of romaciclib (RVU120), a selective CDK8/CDK19 inhibitor, with venetoclax (VEN) in unfit patients with relapsed or refractory AML following frontline VEN+HMA therapy, a patient population of high unmet need with no approved therapies. A total of 58 patients have been dosed with romaciclib and venetoclax combination (median age 76 years), and 31 patients were evaluable for response across cohorts.

第二阶段的RIVER-81研究评估了选择性CDK8/CDK19抑制剂罗马西利布（RVU120）与维奈托克（VEN）联合使用，在接受前线VEN+HMA治疗后复发或难治性AML且不适合其他疗法的患者中的效果，这一患者群体存在高度未满足的需求，且尚无获批的治疗方法。共有58名患者接受了罗马西利布和维奈托克的联合治疗（中位年龄76岁），其中31名患者在各组中可评估疗效。

Romaciclib in combination with VEN demonstrated promising anti-leukemic activity in patients with a historically poor prognosis..

Romaciclib联合VEN在历史上预后较差的患者中显示出有希望的抗白血病活性。

Ryvu Therapeutics S.A. is implementing a project co-funded by the European Union: 'Conducting a multicenter, open-label Phase II clinical trial (RIVER-81) evaluating the safety and efficacy of RVU120 in combination with venetoclax in patients with relapsed/refractory acute myeloid leukemia who have failed prior therapy with venetoclax and a hypomethylating agent.' The project is being carried out under grant agreement no.

Ryvu Therapeutics S.A. 正在实施一个由欧盟共同资助的项目：“开展一项多中心、开放标签的 II 期临床试验（RIVER-81），评估 RVU120 联合维奈托克用于治疗曾经接受过维奈托克和低甲基化药物治疗但失败的复发/难治性急性髓系白血病患者的安全性和有效性。”该项目正在拨款协议编号下进行。

2022/ABM/06/00002 – 00..

2022/ABM/06/00002 – 00..

Poster Title:

海报标题：

An open-label, phase I/II clinical trial of romaciclib (RVU120) as monotherapy and in combination with ruxolitinib in patients with intermediate or high-risk, primary or secondary myelofibrosis (

一项开放标签、I/II 期临床试验，评估罗马西利布（RVU120）单药治疗及与鲁索替尼联合用于中危或高危原发性或继发性骨髓纤维化患者的疗效 (

POTAMI-61

POTAMI-61

)

)

Session name:

会话名称：

634. Myeloproliferative syndromes: Clinical and epidemiological: Poster 1

634. 骨髓增生综合征：临床与流行病学：海报1

Poster number:

海报编号：

2045

2045

The Phase II POTAMI-61 study evaluates romaciclib as monotherapy and in combination with ruxolitinib (RUX) in patients with myelofibrosis (MF) who have failed or shown suboptimal response to JAK inhibitor therapy.

POTAMI-61二期研究评估了romaciclib单药治疗以及与鲁索替尼（RUX）联合用于对JAK抑制剂治疗失败或反应不佳的骨髓纤维化（MF）患者的效果。

Overall, 25 patients were treated (13 in Cohort 1 as monotherapy and 12 in Cohort 2 in combination with RUX), of which 14 patients completed at least 12 weeks of treatment for preliminary spleen volume assessment (as of today and updated from the poster data cut-off).

总体而言，共治疗了25名患者（其中13名患者为单药治疗的队列1，12名为与RUX联合治疗的队列2），其中14名患者完成了至少12周的治疗以进行初步脾脏体积评估（截至目前，并已从海报数据截止日期更新）。

Posters are now available online and can be downloaded from Ryvu website:

海报现已在线提供，可从Ryvu网站下载：

https://ryvu.com/publications

https://ryvu.com/publications

as well as from the conference website:

以及来自会议网站：

https://www.hematology.org/meetings/annual-meeting

https://www.hematology.org/meetings/annual-meeting

Upcoming poster sessions:

即将进行的海报展示环节：

Additional updates, including data from romaciclib’s ongoing REMARK study in lower-risk MDS and dapolsertib (MEN1703) in aggressive B-cell lymphomas, will be shared on December 8, 2025.

包括romaciclib在较低风险MDS中的REMARK研究数据，以及dapolsertib（MEN1703）在侵袭性B细胞淋巴瘤中的数据在内的更多更新，将于2025年12月8日分享。

Poster Title: REMARK

海报标题：REMARK

: A phase II, open-label, multicenter study of orally administered romaciclib (RVU120) for the treatment of anemia in patients with lower-risk myelodysplastic neoplasms (LR-MDS)

：一项口服罗马西尼（RVU120）治疗低风险骨髓增生异常肿瘤（LR-MDS）患者贫血的二期、开放标签、多中心研究

Session name:

会话名称：

637. Myelodysplastic syndromes: Clinical and Epidemiological: Poster 3

637. 骨髓增生异常综合征：临床与流行病学：海报 3

Session date and time:

会话日期和时间：

December 8, 6:00-8:00 PM EST

12月8日，东部时间下午6:00-8:00

Poster number:

海报编号：

5649

5649

Poster Title:

海报标题：

An open-label, phase 2 study of

一项开放标签、2期研究

dapolsertib

达泊西尼

(MEN1703, SEL24) as monotherapy and in combination with glofitamab in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma

(MEN1703，SEL24) 作为单药治疗以及与glofitamab联合使用，用于复发或难治性侵袭性B细胞非霍奇金淋巴瘤患者。

Session name:

会话名称：

627. Aggressive lymphomas: Targeted and pharmacologic therapies: Poster 3

627. 侵袭性淋巴瘤：靶向和药物治疗：海报3

Session date and time:

会话日期和时间：

December 8, 6:00-8:00 PM EST

12月8日，东部时间下午6:00-8:00

Poster number:

海报编号：

5481

5481

Semantic keywords: Hematology, Primary Myelofibrosis, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Janus Kinase Inhibitors, venetoclax, United States, Ryvu Therapeutics, RIVER-81, POTAMI-61, romaciclib, RVU120, American Society of Hematology, ASH 2025, acute myeloid leukemia, relapsed AML, refractory AML, JAK inhibitors, Phase II REMARK trial, LR-MDS, JASPIS-01, dapolsertib, MEN1703, SEL24, selective CDK8/CDK19 inhibitor, ruxolitinib, RUX, primary myelofibrosis, secondary myelofibrosis.

语义关键词：血液学、原发性骨髓纤维化、白血病、髓系、急性、骨髓增生异常综合征、Janus激酶抑制剂、venetoclax、美国、Ryvu Therapeutics、RIVER-81、POTAMI-61、romaciclib、RVU120、美国血液学会、ASH 2025、急性髓系白血病、复发性AML、难治性AML、JAK抑制剂、II期REMARK试验、LR-MDS、JASPIS-01、dapolsertib、MEN1703、SEL24、选择性CDK8/CDK19抑制剂、ruxolitinib、RUX、原发性骨髓纤维化、继发性骨髓纤维化。

About

关于

Ryvu Therapeutics

鲁维治疗学

Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel oncology therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules and antibody-drug conjugates directed at kinases, synthetic lethality, and immuno-oncology targets..

Ryvu Therapeutics是一家临床阶段的药物发现与开发公司，专注于针对肿瘤学新兴靶点的创新肿瘤疗法。Ryvu内部发现的候选管线利用了癌症生物学新兴知识驱动的多样化治疗机制，包括小分子和抗体药物偶联物，针对激酶、合成致死性和免疫肿瘤学靶点。

Ryvu’s most advanced program is romaciclib (RVU120, SEL120), a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies. RVU120 is currently in Phase II development (i) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (ii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study, (iii) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) – the POTAMI-61 study.

Ryvu公司最先进的项目是romaciclib（RVU120，SEL120），这是一种选择性CDK8/CDK19激酶抑制剂，有潜力治疗血液系统恶性肿瘤。RVU120目前处于II期开发阶段：(i) 与venetoclax联合用于治疗r/r AML患者——RIVER-81研究，(ii) 作为单药治疗低风险骨髓增生异常综合征（LR-MDS）患者——REMARK研究，(iii) 作为单药以及与ruxolitinib联合用于治疗骨髓纤维化（MF）患者——POTAMI-61研究。

Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group that is currently being investigated in a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study. RVU305, a potentially best-in-class, brain-permeable PRMT5 inhibitor aiming to treat multiple solid tumors, is currently in IND/CTA-enabling studies.

达泊塞尔替布（Dapolsertib，MEN1703，SEL24）是一种双重PIM/FLT3激酶抑制剂，已授权给美纳里尼集团，目前正在进行一项针对弥漫性大B细胞淋巴瘤（DLBCL）的二期研究——JASPIS-01研究。RVU305是一种潜在的同类最佳、可穿透血脑屏障的PRMT5抑制剂，旨在治疗多种实体瘤，目前正处于IND/CTA支持性研究阶段。

Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis..

Ryvu Therapeutics还与BioNTech和Exelixis在肿瘤学领域展开合作。

Ryvu was founded in 2007 and is headquartered in Kraków, Poland. It is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index.

Ryvu 成立于2007年，总部位于波兰克拉科夫。该公司在华沙证券交易所上市，是sWIG80指数的成分股。

C

C

ontact

联系

Ryvu Therapeutics

Ryvu治疗学

Anna Wilk

安娜·威尔克

+48 532 698 425

+48 532 698 425

This email address is being protected from spambots. You need JavaScript enabled to view it.

该电子邮件地址正受到垃圾邮件程序的保护。您需要启用 JavaScript 才能查看它。

1. CRx; CRx - composite complete remission, including both complete remission (CR) and complete remission with incomplete blood count recovery (CRi)

1. CRx；CRx - 复合完全缓解，包括完全缓解（CR）和血液计数未完全恢复的完全缓解（CRi）

Source: Biotech Newswire

来源：生物技术新闻社