- Romaciclib combined with venetoclax (VEN) shows encouraging anti-leukemic activity, including durable responses, in patients with relapsed/refractory acute myeloid leukemia after VEN-based therapy failure (RIVER-81). These results support further clinical development at the selected dose.
- Romaciclib demonstrates a favorable safety profile and clinical activity in myelofibrosis, both as monotherapy and in combination with ruxolitinib (POTAMI-61). The observed spleen volume reductions and hematologic tolerability support continued clinical evaluation.
KRAKOW, Poland, May 12, 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, today announced it will present 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 happy to share new data that confirm the strength and potential of romaciclib across hematologic malignancies. The results to be presented at EHA highlight consistent clinical activity and a manageable safety profile, both as a single agent and in rationale combinations, including in difficult-to-treat patient populations. These findings reinforce our confidence in romaciclib’s differentiated mechanism of action and support its continued clinical advancement."
Details on the abstract presentations are as follows:
Title: 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
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 3 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, with the most consistent responses at romaciclib 150 mg QD + VEN 400 mg QD, including durable CR/CRi, reported with a cut-off date of 09 February 2026. Based on safety, PK, and preliminary efficacy findings, this regimen was selected as the recommended dose for expansion. Further evaluation is planned to better define durability of response and clinical benefit.
Title: 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
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 (RVU120) is a first-in-class, oral CDK8/19 inhibitor that modulates STAT-dependent transcription and showed 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 and further evaluation in expansion cohorts.
The abstracts are now available online and can be obtained from the conference site: https://ehaweb.org/
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; Clinical Trials, Phase I as Topic; venetoclax; ruxolitinib; Primary Myelofibrosis; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Lymphoma; Poland; Ryvu Therapeutics; romaciclib; RVU120; European Hematology Association Congress; EHA; clinical data; hematologic malignancies; relapsed/refractory acute myeloid leukemia; acute myeloid leukemia; AML; venetoclax; VEN; VEN-based therapy; RIVER-81; anti-leukemic activity; myelofibrosis; ruxolitinib; RUX; POTAMI-61; CDK8/CDK19 inhibitor
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 (i) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (ii) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) – the POTAMI-61 study, (iii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study. 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, MTA-cooperative PRMT5 inhibitor aiming to treat multiple solid tumors, is currently in 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