Azacitadine Demonstrates Efficacy in a Phase 2 Trial of PTCL

Jia Ruan, MD, PhD, associate professor of Clinical Medicine in the Division of Hematology and Medical Oncology at Weill Cornell Medicine, discusses the results of the multicenter phase 2 trial (NCT03542266) of oral azacitidine (CC-486) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as initial treatment in patients with peripheral T-cell lymphoma (PTCL).

Ruan says she and the other investigators were happy with the results of the study. The study drug was well tolerated, and the adverse events were as expected with CHOP-based therapy. Most patients were able to complete 6 cycles of treatment without any dose reductions for the chemotherapy. Approximately 10 patients successfully received consolidated transplant after their treatment, which she says is significant.

In the 20 evaluable patients with PTCL, the complete response (CR) rate was 75% at the end of therapy. It is notable that in the subgroup analysis, patients with transformed follicular phenotype with recurrent epigenetic modifier had a CR rate of 88%. Historically, CHOP-based chemotherapy has about a 40% CR rate, which makes the responses to azacitidine and CHOP a significant improvement. This is very encouraging, according to Ruan.