Long-term follow-up of patients with relapsed or refractory non-hodgkin lymphoma treated with venetoclax in a phase 1, first-in-human study
- Author(s)
- Davids, MS; Roberts, AW; Kenkre, VP; Wierda, WG; Kumar, A; Kipps, TJ; Boyer, M; Salem, AH; Pesko, J; Arzt, J; Mantas, M; Kim, SY; Seymour, JF;
- Journal Title
- Clinical Cancer Research
- Publication Type
- epub ahead of print
- Abstract
- PURPOSE: We previously reported a 44% overall response rate (ORR) with venetoclax in a phase 1 study of relapsed/refractory NHL. Complete remission (CR) was observed in patients with mantle cell lymphoma ([MCL], 21%, n=6/28) and follicular lymphoma ([FL], 17%, n=5/29), and partial response (PR) noted in several patients with Waldenström macroglobulinemia (WM), and marginal zone lymphoma (MZL). Here, we report the long-term outcomes of these four cohorts. PATIENTS AND METHODS: All patients (n=106) received venetoclax monotherapy in dose cohorts of 200 - 1200 mg daily until disease progression or unacceptable toxicity. ORR, PFS, DoR, and adverse events (AEs) were evaluated. RESULTS: At median follow-up of 38.5 months (range: 30.0 - 46.5), median PFS for 106 patients was 5.4 (95% CI: 3.5 - 8.4) months (FL: 10.8; MCL: 11.3; MZL: 21.2; WM: 30.4). Median DoR was 14.9 (95% CI: 9.7 - 27.6) months (FL: 26.6; MCL: 15.7; MZL: 20.1; WM: 25.3). Achievement of CR vs. PR predicted longer DoR in both MCL (31.5 vs. 10.1 months) and FL (37.6 vs. 9.7 months). All grade hematologic AEs were infrequent: neutropenia (19%), anemia (17%), and thrombocytopenia (15%), with no new cytopenias {greater than or equal to}2 years on therapy. Non-hematological AEs included nausea (47%), diarrhea (43%), fatigue (40%), with decreased incidence {greater than or equal to}1 year. CONCLUSIONS: Venetoclax monotherapy has a manageable safety profile and achieves durable responses in a subset of patients with FL, MCL, WM, and MZL, particularly in those who achieve CR. Further research is warranted on combination strategies to enhance the durability of response to venetoclax.
- Publisher
- AAACR
- Research Division(s)
- Blood Cells And Blood Cancer
- PubMed ID
- 34083230
- Publisher's Version
- https://doi.org/10.1158/1078-0432.Ccr-20-4842
- Open Access at Publisher's Site
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Creation Date: 2021-06-10 11:46:59
Last Modified: 2021-06-10 12:10:47