Umbralisib approved for the treatment of select patients with relapsed/refractory marginal zone lymphoma and relapsed/refractory follicular lymphoma.
The agent is specifically indicated for adult patients with relapsed/refractory MZL who have previously received at least 1 anti-CD20–based regimens.
it is also approved for use in adult patients with relapsed/refractory follicular lymphoma who have previously received at least 3 lines of systemic treatment.
Umbralisib approval was primarily based on data from the marginal zone lymphoma and follicular lymphoma patient cohorts of the phase 2b UNITY-NHL trial.
Treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least 1 prior anti-CD20 based regimen or follicular lymphoma (FL) after at least 3 prior systemic therapies.
It is a once-daily, oral, dual inhibitor of PI3K-d and CK1-epsilon.
Trade name Ukoniq.
Participants received umbralisib at a once-daily dose of 800 mg until progressive disease or intolerable toxicity.
Results showed that the agent elicited an overall response rates of 49% and 16% experienced complete responses.
The median duration of response had not yet been reached.
For patients with follicular lymphoma, the overall response rates was 43% with 3% achieving complete responses.
Median DOR was 11.1 months.
Adverse events observed in at least 15% of patients: increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.
Serious AEs occurred in 18% of patients, most often from diarrhea-colitis and infection.
The most common reasons for dose modifications were diarrhea-colitis and transaminase elevation.