The following is a summary of “Phase II single-arm study of a combination of obinutuzumab and venetoclax in early relapsed or refractory diffuse large B-cell lymphoma—final results of the AGMT NHL15B study,” published in the March 2024 issue of Hematology by Jaeger al.
Researchers conducted a retrospective study evaluating the efficacy of obinutuzumab and venetoclax in patients with diffuse large B-cell lymphoma (DLBCL) experiencing early relapse or primary refractoriness to rituximab (R) and CHOP therapy.
A single-arm study enrolled 21 DLBCL patients (relapsed within 12 months or primary refractory), exhibiting detectable Bcl-2 protein expression and CD20 positivity (2016 to 2021). Administering 1,000 mg of Obinutuzumab intravenously on days 1, 8, and 15 in cycle 1 and on day 1 of subsequent 21-day cycles, along with daily oral intake of 800 mg Venetoclax, constituted the treatment regimen, which lasted for up to three cycles. Eligible patients were slated for cellular therapies or up to nine maintenance cycles, with ORR as the primary endpoint after three cycles.
The results showed 21 patients (median age, 64 years) with refractory or early relapsed DLBCL after one (N = 11) to four previous lines of therapy were included. The majority received three cycles of obinutuzumab/venetoclax (range, 1–8). The regimen was well tolerated, with manageable cytopenias and infections. Severe adverse events related to treatment were observed in 9.5%. The ORR was 38.1% (8/21 patients), with the best response of five complete remissions (CRs; 23.8%) and three partial remissions (PRs; 14.2%). The primary endpoint (45% ORR) was not met. Response duration was 83.3% at 84 days, with a progression-free survival of 38.8% at 84 days, 25.9% at 168 days, and a median overall survival of 169.1 weeks. All deaths were due to underlying disease. Seven patients became eligible for autologous transplants. Nine patients (42.8%) received 11 cellular therapies (5 ASCT and 6 CAR-T). Three patients went directly from obinutuzumab/venetoclax to CAR-T therapy. All patients had successful peripheral stem cell or T-cell harvests. Characteristics of responders include relapsed disease (response rate, 6 of 11 = 54%), very good or good R-IPI (7 of 8), and a low number of previous therapies (median = 1).
Investigators concluded that obinutuzumab combined with venetoclax was a successful relapse treatment for DLBCL with minimal side effects. This allows for potential follow-up with cellular therapies like CAR-T cells.
Source: frontiersin.org/articles/10.3389/frhem.2024.1331008/full