The combination of umbralisib and ublituximab demonstrated activity in patients with relapsed/refractory marginal zone lymphoma (MZL), according to results of the phase 2 UNITY-NHL trial.
The results were presented at the 2021 American Society of Hematology (ASH) Annual Meeting by Julio C. Chavez, MD, of Moffitt Cancer Center in Tampa, Florida.
The UNITY-NHL trial (ClinicalTrials.gov Identifier: NCT02793583) included 72 patients with previously treated MZL (splenic, nodal, or extranodal). Patients had received 1 or more prior lines of therapy, which must have included an anti-CD20 antibody.
The patients’ median age was 70 years (range, 40-89 years), and 53% were women. Patients had received a median of 2 prior therapies (range, 1-9), and 25% were refractory to their immediate prior therapy.
Patients received oral umbralisib at 800 mg daily until disease progression, unacceptable toxicity, or study withdrawal. They received ublituximab at 900 mg intravenously on days 1, 8, and 15 of cycle 1, on day 1 of cycles 2-6, then on day 1 every 3 cycles until cycle 24 (in 28-day cycles).
The study’s primary endpoint was objective response rate (ORR). The median follow-up was 20 months. At last follow-up, 47% of patients were still on treatment.
The ORR was 70%, and the disease control rate (DCR) was 93%, according to an independent review committee (IRC). The complete response (CR) rate was 21%, the partial response (PR) rate was 49%, and 23% of patients had stable disease (SD) by IRC assessment.
According to investigator assessment, the ORR was 75%, and the DCR was 90.3%. The CR rate was 25%, the PR rate was 50%, and 15% of patients had SD.
The median duration of response was not reached, and the median progression-free survival was 17.61 months, according to IRC assessment. When the data were censored for COVID-19-related deaths, the median progression-free survival was not reached.
The most common grade 3 or higher adverse events were diarrhea (13%), neutropenia (18%), and ALT/AST increase (16%). Among patients who experienced grade 3 or higher diarrhea, only 1 patient was managed with steroids.
A total of 7 patients (10%) discontinued treatment due to an adverse event.
Based on these results, Dr Chavez concluded that umbralisib plus ublituximab has an “acceptable” safety profile and “favorable clinical activity,” and it could be a chemotherapy-free option for patients with relapsed/refractory MZL.
Disclosures: This research was supported by TG Therapeutics, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of the ASH 2021 meeting by visiting the conference page.
Chavez JC, Goldschmidt N, Samaniego F, et al. The combination of umbralisib plus ublituximab is active in patients with relapsed or refractory marginal zone lymphoma (MZL): Results from the phase 2 global UNITY-NHL trial. Presented at ASH 2021; December 11-14, 2021. Abstract 45.