A new combination treatment may offer a promising option for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL), according to early trial results from China. The phase 1 study tested linperlisib, a PI3Kδ inhibitor, together with chidamide, a histone deacetylase inhibitor, in 22 patients with advanced CTCL.
Participants had previously received a median of three systemic therapies. Of the group, 86.4 percent had mycosis fungoides and 13.6 percent had Sézary syndrome. The objective response rate was 59.1 percent, including two complete and eleven partial responses. Mycosis fungoides patients saw a response rate of 63.2 percent, while the rate for Sézary syndrome was 33.3 percent. The disease control rate reached 86.4 percent, and median progression-free survival was 5.4 months.
The treatment was generally well tolerated. Most side effects were mild or moderate, with the most common being nausea, itching, and rash. Five patients (22.7 percent) experienced grade 3 adverse events, but no grade 4 or 5 events occurred. No dose-limiting toxicities were observed, and 80 mg of linperlisib daily was recommended for future trials.
These findings suggest that the combination of linperlisib and chidamide, both taken orally, may provide a new treatment option for patients with few alternatives. Researchers noted the need for further studies to confirm these early results, but the safety and response rates are encouraging for those with advanced CTCL, particularly the mycosis fungoides subtype.
Reference
Pang Z et al. Linperlisib plus chidamide in relapsed or refractory cutaneous t-cell lymphoma: a nonrandomized clinical trial. JAMA Dermatol. 2025:e251926.
