- Romaciclib in acute myeloid leukemia (AML):
- In the RIVER-81 Phase II study, romaciclib combined with venetoclax (VEN) shows encouraging anti-leukemic activity, including durable responses, in patients with relapsed/refractory AML (r/r AML) after VEN-based therapy failure. These results support further clinical development at the selected dose.
- On May 28, 2026, the Food and Drug Administration (FDA) reactivated the IND, enabling the initiation of the expansion cohort at the recommended dose of 150 mg once daily (QD).
- Romaciclib in myelofibrosis (MF):
- In the POTAMI-61 Phase II study, romaciclib demonstrates a favorable safety profile and clinical activity in myelofibrosis (MF), both as monotherapy and in combination with ruxolitinib (RUX). The observed spleen volume reductions and hematologic tolerability support continued clinical evaluation.
- Eight patients from POTAMI-61 will continue treatment in the ROVER-01 study, reflecting ongoing clinical benefit in a subset of patients.
KRAKOW, Poland, June 11, 2026 / Biotech Newswire / -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, presents romaciclib (RVU120) data at the European Hematology Association Congress (EHA), June 11-14, 2026, in Stockholm, Sweden.
Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics said: We are pleased to share updated clinical data at EHA that reinforce the potential of romaciclib across hematologic malignancies. The poster presentations highlight consistent clinical activity and a manageable safety profile, both as a single agent and in rational combinations, including in difficult-to-treat patient populations. Importantly, the FDA review of the program and the recent reactivation of the RIVER-81 IND in the US as well as the continued treatment of patients from POTAMI-61 in the ROVER-01 study, are meaningful signals reflecting both regulatory progress and continued patient benefit. These milestones strengthen our confidence in romaciclib's differentiated mechanism of action and support its continued clinical advancement.
Program updates:
In the RIVER-81 trial of patients with r/r AML, Ryvu is initiating an expansion cohort of approximately 30 patients to confirm the positive efficacy demonstrated in the dose cohort of 150 mg QD romaciclib combined with 400 mg QD venetoclax. Following completion of the required regulatory steps, including an updated study protocol and submission of documentation under the existing IND, the FDA reactivated the IND for RIVER-81 study on May 28, 2026.
In the POTAMI-61 study investigating romaciclib’s efficacy in MF, eight patients will be transferred into the ROVER-01 study rollover protocol, underscoring that a subset of patients continue to derive meaningful clinical benefit from romaciclib treatment. These patients will continue to receive treatment with romaciclib as long as they benefit in ROVER-01.
EHA poster presentations:
Poster (PF529): Updated findings from the Phase 2 RIVER-81 study of romaciclib (RVU120) combined with venetoclax in acute myeloid leukemia after first-line venetoclax and hypomethylating agent failure
Poster session date and time: Friday, June 12 (6:45 - 7:45 PM CEST)
Venetoclax (VEN) combined with hypomethylating agents is the standard first-line treatment for patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy, yet ~70% experience relapsed/refractory disease with a median survival of under three months. Romaciclib, a first-in-class CDK8/CDK19 inhibitor, has shown single-agent activity in AML and preclinical synergy with VEN through enhanced apoptotic signaling and attenuation of resistance pathways.
In the ongoing Phase 2 RIVER-81 trial, romaciclib in combination with VEN demonstrates anti-leukemic activity in patients with poor prognostic AML. While responses have been observed across dose levels, the most consistent responses were seen at romaciclib 150 mg QD + VEN 400 mg QD, including two complete remissions with (CR) and one without (CRi) full hematologic recovery, resulting in a CR/CRi rate of 43% (3/7). The mean duration of response (DoR) of the CRs was 156 days, reported with a cut-off date of 12 May 2026. Based on safety, PK, and preliminary efficacy findings, this regimen was selected as the recommended dose for expansion.
Poster (PS2008): Romaciclib (RVU120), a selective CDK8/19 inhibitor, as monotherapy or in combination with ruxolitinib in patients with myelofibrosis: Updated results from the phase II POTAMI-61 study
Poster session date and time: Saturday, June 13 (6:45 - 7:45 PM CEST)
Myelofibrosis (MF) is driven by dysregulated JAK/STAT signaling, and while JAK inhibition with ruxolitinib (RUX) improves splenomegaly and symptoms, cytopenias and suboptimal responses remain clinical challenges. Romaciclib is a first-in-class, oral CDK8/19 inhibitor that modulates STAT-dependent transcription and shows synergy with RUX in preclinical MF models.
In the ongoing Phase II POTAMI-61 study, romaciclib administered as monotherapy or combined with RUX demonstrates a manageable safety profile in patients with MF without significant treatment-related cytopenias. Prolonged exposure, spleen volume reductions, including in patients with high-molecular-risk mutations, and favorable hematologic tolerability support continued clinical development.
The posters are available online and can be accessed via the conference website: https://ehaweb.org/ and Ryvu’s website: https://ryvu.com/
The project entitled “The conduct of a phase II, multicentre, open-label 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.”, carried out by Ryvu Therapeutics S.A., is co-financed by the Medical Research Agency from the state budget under the “Development of targeted or personalised medicine based on medicinal products involving nucleic acids and small-molecule compounds” call (ABM/2022/6).
Total Project value: PLN 132,471,740.70
Total funding: PLN 62,268,848.90
Semantic keywords: Congresses as Topic; Clinical Trials, Phase II as Topic; Ryvu Therapeutics; romaciclib; RVU120; European Hematology Association Congress; EHA; hematologic malignancies; oncology; acute myeloid leukemia; AML; relapsed/refractory AML; r/r AML; myelofibrosis; MF; RIVER-81; POTAMI-61; ROVER-01; venetoclax; VEN; ruxolitinib; RUX; CDK8/CDK19 inhibitor; selective CDK8/CDK19 inhibitor; drug development; clinical data; program update; clinical activity; anti-leukemic activity; combination therapy; JAK inhibition; JAK/STAT signaling
About Ryvu Therapeutics
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’s most advanced program is romaciclib (RVU120, SEL120), a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. Romaciclib is currently in Phase II development in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study. Additional studies are ongoing including medulloblastoma, the MEDWAY collaboration with the Children's Memorial Health Institute, and in myelofibrosis.
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, has completed IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis.
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.
Contact
Ryvu Therapeutics
Anna Wilk
+48 532 698 425
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Source: Biotech Newswire