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MESSAGE _ENGLISH VERSION_
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Clinical data on romacyclib to be presented at the 2026 European
Hematology Association Congress
The Management Board of Ryvu Therapeutics S.A. with its registered
office in Krakow, Poland _"Company", "Ryvu"_ announces that it will
present romaciclib _RVU120_ clinical data at the European Hematology
Association Congress _EHA_, June 11-14, 2026, inStockholm, Sweden.
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 forpatients 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 150mgQD + 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/
Disclaimer: This English language translation has been prepared solely
for the convenience of English-speaking readers. Despite all the efforts
devoted to this translation, certain discrepancies, omissions or
approximations may exist. In case of any differences between the Polish
and the English versions, the Polish version shall prevail. Ryvu
Therapeutics S.A., its representatives and employees decline all
responsibility in this regard.
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RB: Prezentacja danych klinicznych romacyklibu podczas Kongresu Europejskiego Stowarzyszenia
Hematologicznego (EHA) 2026 / Clinical data on romacyclib to be presented at the 2026
European Hematology Association Congress
