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Published on: May 4, 2017
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Phase I/II Study of Subasumstat (TAK-981) in Combination With Rituximab in Relapsed/Refractory Non-Hodgkin Lymphoma
Sarit E Assouline1, Amitkumar Mehta2, Walter Hanel3
1Jewish General Hospital, McGill University, Montreal, QC, Canada.
Clinical Lymphoma, Myeloma & Leukemia
|June 4, 2025
Summary
Subasumstat, an innate immunity enhancer, combined with rituximab showed a positive benefit-risk profile in patients with non-Hodgkin lymphoma. The combination therapy demonstrated promising antitumor activity and immune response induction.
Area of Science:
- Immunology
- Oncology
- Pharmacology
Background:
- Subasumstat (TAK-981) is a novel innate immunity enhancer targeting SUMOylation to activate immune responses.
- Preclinical studies showed Subasumstat enhances antitumor activity of rituximab.
Purpose of the Study:
- To evaluate the safety and efficacy of Subasumstat combined with rituximab in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).
Main Methods:
- A phase I/II study enrolled 34 patients with CD20+-positive NHL.
- Patients received escalating doses of intravenous Subasumstat (10-120 mg QW or BIW) with rituximab (375 mg/m²).
Main Results:
- No dose-limiting toxicities were observed up to 120 mg QW; safety was comparable across QW cohorts.
- The most common adverse events were pyrexia, chills, and fatigue, consistent with interferon pathway activation.
- An objective response rate of 27.6% was observed in evaluable patients on QW dosing, with evidence of target engagement and immune response induction.
Conclusions:
- Subasumstat combined with rituximab demonstrated a positive benefit-risk profile in NHL.
- The combination therapy showed promising signs of efficacy and immune activation.

