Rovadicitinib Shows Efficacy and Manageable Safety for Ruxolitinib-Resistant or Intolerant Myelofibrosis
Rovadicitinib (TQ05105), a first-in-class oral JAK/ROCK inhibitor, demonstrated promising spleen and symptom responses with a favorable safety profile among patients with myelofibrosis (MF) who were relapsed/refractory or intolerant to prior ruxolitinib, according to study results published in European Journal of Pharmacology.
Previous research has found promising clinical activity for rovadicitinib among patients with MF, including improved spleen responses and reduced symptom burden. Researchers conducted a single-arm, multicenter, open-label phase 1b trial to determine the safety and efficacy of rovadicitinib among patients intolerant to ruxolitinib.
Overall, 9 patients with relapsed/refractory or ruxolitinib-intolerant MF were enrolled between August 2022 and September 2023. The median prior ruxolitinib exposure was 40.6 months. At the time of analysis, patients had received a median of 12.5 months of rovadicitinib therapy.
The spleen volume response rate (SVRR), defined as at least 35% spleen volume reduction from baseline at the end of cycle 6 (EOC6), was 25%. Symptom response rate (SRR), based on at least 50% reduction in total symptom score was 37.5%.
In terms of safety, the most common grade 3 or higher treatment-emergent adverse event was thrombocytopenia (33.3%). There were no bleeding events, and only 1 patient discontinued treatment due to toxicity.
The researchers concluded, “This study suggests that patients with MF who are intolerant or resistant to ruxolitinib or other JAK inhibitors might achieve significant clinical benefit after treatment with rovadicitinib.”
Source:
Hong M, Ding D, Zhang M, et al. A first-in-class JAK/ROCK inhibitor, Rovadicitinib in patients with myelofibrosis who were refractory or relapsed or intolerant to Ruxolitinib: A single-arm, multicenter, open-label, phase Ib study. European Journal of Pharmacology. Published online October 15, 2025. doi:10.1016/j.ejphar.2025.178032
