Favorable Safety Seen With Oral Azacitidine for Follicular Helper T-Cell Lymphoma

By Andrew Moreno - Last Updated: August 8, 2024

Oral azacitidine presented a favorable safety profile when compared with standard therapy for relapsed or refractory follicular helper T-cell lymphoma (TFHL). This was the main takeaway from the open-label, randomized, phase III ORACLE study published in The Lancet Haematology.

Advertisement

The multinational study cohort included 86 adult patients with relapsed or refractory TFHL, with a median age of 69 years. Patients were divided into two treatment groups, with 42 receiving oral azacitidine 300 mg once daily for 14 days in a 28-day cycle and 44 receiving standard therapy. Patients in the standard therapy group received gemcitabine, bendamustine, or romidepsin per investigator’s choice.

The study’s primary endpoint was progression-free survival (PFS) in the intention-to-treat population. Median PFS was 5.6 months in the azacitidine group compared with 2.8 months in the standard therapy group (hazard ratio, 0.63; 1-sided P=.042).

Grade 3-4 adverse events (AEs) were reported by 76% of patients in the azacitidine group versus 98% of those in the standard therapy group.

Regarding the most severe grade 3 or worse AEs, hematological events occurred in 67% of the azacitidine group and 93% of the standard therapy group, infection in 19% of the azacitidine group and 33% of the standard therapy group, and gastrointestinal events in 12% of the azacitidine group and 2% of the standard therapy group.

There were two treatment-related mortalities in the azacitidine group and three in the standard therapy group.

“Although the prespecified primary outcome of the trial was not met, the favorable safety profile suggests that azacitidine could add to the treatment options in these difficult-to-treat diseases, especially in combination with other drugs,” the study authors concluded.

This study was funded by Bristol Myers Squibb.

Reference

Dupuis J, Bachy E, Morschhauser F, et al. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024. doi:10.1016/S2352-3026(24)00102-9

Advertisement
Advertisement
Advertisement
Editorial Board