Tucidinostat appears safe and effective in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL), according to research published in Haematologica.
Researchers conducted a phase 2b study to evaluate tucidinostat, previously called chidamide, in patients with relapsed/refractory PTCL (ClinicalTrials.gov identifier: NCT02953652). The trial enrolled patients 20 years of age or older who had received at least 1 line of systemic chemotherapy.
A total of 55 patients were treated with oral tucidinostat at 40 mg twice per week until progressive disease or unacceptable toxicity. Most patients had PTCL not otherwise specified (n=37). The patients’ median age was 71 years (range, 38-87), and 64% were men. The median number of prior systemic therapies patients received was 2 (range, 1-9).
There were 46 patients evaluable for efficacy. The primary endpoint was overall response rate (ORR), as assessed by an independent review committee.
The ORR was 46%. Of the 21 patients who achieved a response, 5 had complete responses and 16 had partial responses.
Responses were observed across PTCL subtypes. The ORR was 100% in the single patient with enteropathy-associated T-cell lymphoma, 88% in the patients with angioimmunoblastic T-cell lymphoma (7/8), 35% in patients with PTCL not otherwise specified (12/34), and 33% in patients with ALK-negative anaplastic large-cell lymphoma (1/3).
At a median follow-up of 8.3 months, the median duration of response was 11.5 months. The median progression-free survival was 5.6 months, and the median overall survival was 22.8 months.
All 55 patients were evaluable for safety. The most common adverse events (AEs) of any grade were thrombocytopenia (84%), neutropenia (56%), leukopenia (44%), anemia (33%), diarrhea (31%), lymphopenia (29%), decreased appetite (24%), nausea (22%), and pyrexia (20%).
The most common grade 3 or higher AEs were thrombocytopenia (51%), neutropenia (36%), leukopenia (20%), and lymphopenia (22%). The investigators found that most AEs were manageable with supportive care and dose modification.
“Together, the favorable efficacy and safety results indicate that tucidinostat is a promising new therapeutic option in patients with R/R PTCL,” the researchers concluded.
Disclosures: This study was funded by HUYABIO International, LLC. One study author is employed by the company. Please see the original reference for a full list of disclosures.
Rai S, Kim WS, Ando K, et al. Oral HDAC inhibitor tucidinostat in patients with relapsed or refractory peripheral T-cell lymphoma: Phase IIb results. Haematologica. Published online October 6, 2022. doi:10.3324/haematol.2022.280996