- 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.
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 Haematology 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
