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Zanubrutinib, obinutuzumab, and venetoclax (BOVen) in patients with treatment-naïve CLL
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Venetoclax-obinutuzumab induces durable uMRD at ≤10-4 (uMRD4) in treatment-naïve (TN) CLL, and BCL2i/BTKi combinations are synergistic treatment modalities. The combination of zanubrutinib, obinutuzumab, and venetoclax (BOVen) has demonstrated tolerability with frequent uMRD in patients with TN CLL. Results from a multicenter, phase II trial investigating the efficacy and safety of BOVen in patients with TN CLL were presented at the 66th ASH Annual Meeting and Exposition by Soumerai.1 Long-term follow-up of BOVen (28-day cycles), preliminary safety/efficacy of retreatment with zanubrutinib-venetoclax (12–24 cycles, discontinue after 12 cycles if uMRD in PB and BM), and the impact of response kinetics (DMRD400) on outcomes were accessed. The primary endpoint was achieving uMRD4 in both PB and BM.1 |
| Key learnings |
| Overall, 96% of patients achieved uMRD4 in PB, and 92% in both PB and BM. The median MRD4-free survival of 92% achieving BM uMRD was 34 months. |
| Retreatment with zanubrutinib-venetoclax was effective and well-tolerated, with an iwCLL ORR of 92% and PB uMRD in 46% of patients. Those who achieved DMRD400 with BOVen initial therapy were more likely to achieve PB uMRD with retreatment (75% vs 29%). |
| No additional safety signals were reported, and Grade ≥3 adverse events were infrequent. |
| This 5-year follow-up of BOVen demonstrates high rates of uMRD4 and durable responses in patients with TN CLL. Retreatment with zanubrutinib-venetoclax was also effective and well-tolerated. A phase II trial of BOVen with ΔMRD400-directed treatment duration is ongoing. |
Abbreviations: ΔMRD40, ≥400-fold reduction in peripheral blood [PB] MRD level by immunosequencing from baseline to Cycle 5 Day 1; BCL2i, B-cell lymphoma 2 inhibitor; BM, bone marrow; BOVen, zanubrutinib, obinutuzumab, and venetoclax; BTKi, Bruton’s tyrosine kinase inhibitor; CLL, chronic lymphocytic leukemia; iwCLL, International Workshop on Chronic Lymphocytic Leukemia; MRD, measurable residual disease; ORR, overall response rate; PB, peripheral blood; SLL, small lymphocytic lymphoma; MRD4, MRD at ≤10-4; TN, treatment-naive; uMRD, undetectable MRD.
- Soumerai JD. Multicenter phase II trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in treatment-naïve chronic lymphocytic leukemia: 5-year follow up, retreatment outcomes, and impact of MRD kinetics (ΔMRD400). Poster #1867. American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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