A phase 2 trial in China recorded tumour responses in 42 of 115 people with previously treated diffuse large B-cell lymphoma. Severe treatment-related adverse effects occurred in 111 of 128 participants assessed for safety, mainly affecting blood counts. The single-arm study describes activity and toxicity but cannot compare survival with another treatment.
Measurable tumour shrinkage was recorded with ifupinostat in a phase 2 investigation involving people with diffuse large B-cell lymphoma that had returned or resisted treatment. Participants had already received at least two systemic treatment lines. The peer-reviewed report covers 28 Chinese hospitals. Of 128 people enrolled, central diagnostic review left 115 in the efficacy assessment; 42 responded, including 13 with a complete response.[1]
The treatment inhibits two cellular targets and was infused on six days during each 21-day cycle. Among all 128 participants followed for safety, 111 experienced treatment-related adverse effects graded 3 or higher, meaning severe or worse. Particularly prominent were low platelets, the blood components involved in clotting. Severe platelet depletion attributed to the drug affected 75.8%. Clinical management included blood monitoring, supportive care and dose changes; no deaths were attributed to treatment.[1]
The response rate was 36.5%, and responses lasted a median 6.2 months. Median survival across the efficacy group was 9.9 months at the July 2023 cutoff. These describe different outcomes: shrinkage does not establish longer survival. Everyone received ifupinostat, so this study cannot show superiority over another treatment. The population was limited to China, and several authors worked for BeBetter Med, the sponsor.[1]
