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Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Open accessAbstract
Purpose: B-cell leukemia/lymphoma-2 (BCL-2) overexpression is common in many non-Hodgkin lymphoma (NHL) subtypes. A phase I trial in patients with NHL was conducted to determine safety, pharmacokinetics, and efficacy of venetoclax, a selective, potent, orally bioavailable BCL-2 inhibitor. Patients and Methods: A total of 106 patients with relapsed or refractory NHL received venetoclax once daily until progressive disease or unacceptable toxicity at target doses from 200 to 1,200 mg in dose-escalation and safety expansion cohorts. Treatment commenced with a 3-week dose ramp-up period for most patients in dose-escalation cohorts and for all patients in safety expansion. Results: NHL subtypes included mantle cell lymphoma (MCL; n = 28), follicular lymphoma (FL; n = 29), diffuse large B-cell lymphoma (DLBCL; n = 34), DLBCL arising from chronic lymphocytic leukemia (Richter transformation; n = 7), Waldenström macroglobulinemia (n = 4), and marginal zone lymphoma (n = 3). Venetoclax was generally well tolerated. Clinical tumor lysis syndrome was not observed, whereas laboratory tumor lysis syndrome was documented in three patients. Treatment-emergent adverse events were reported in 103 patients (97%), a majority of which were grade 1 to 2 in severity. Grade 3 to 4 events were reported in 59 patients (56%), and the most common were hematologic, including anemia (15%), neutropenia (11%), and thrombocytopenia (9%). Overall response rate was 44% (MCL, 75%; FL, 38%; DLBCL, 18%). Estimated median progression-free survival was 6 months (MCL, 14 months; FL, 11 months; DLBCL, 1 month). Conclusion: Selective targeting of BCL-2 with venetoclax was well tolerated, and single-agent activity varied among NHL subtypes. We determined 1,200 mg to be the recommended single-agent dose for future studies in FL and DLBCL, with 800 mg being sufficient to consistently achieve durable response in MCL. Additional investigations including combination therapy to augment response rates and durability are ongoing.
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Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma
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“Emergent* Any event 103 (97) 21 (96) 33 (100) 49 (96) 59 (56) 14 (64) 21 (64) 24 (47) Nausea 51 (48) 9 (41) 15 (45) 27 (53) 0 0 0 0 Diarrhea 48 (45) 7 (32) 14 (42) 27 (53) 3 (3) 0 2 (6) 1 (2) Fatigue 44 (42) 10 (45) 9 (27) 25 (49) 7 (7) 2 (9) 2 (6) 3 (6) Decreased appetite 23 (22) 4 (18) 4 (12) 15 (29) 1 (1) 0 0 1 (2)”
BackgroundInfluentialSelf-citationLeverson, J. D., Phillips, D. C., Mitten, M. J., Boghaert, E. R., Diaz, D., Tahir, S. K., Belmont, L. D., Nimmer, P., Xiao, Y., Ma, X. M., et al. (2015) · Science Translational Medicine · doi:10.1126/scitranslmed.aaa4642 · Cited by 541
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Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma
Kumar, S., Kaufman, J. L., Gasparetto, C., Mikhael, J., Vij, R., Pegourie, B., Benboubker, L., Facon, T., Amiot, M., Moreau, P., et al. (2017) · Blood · doi:10.1182/blood-2017-06-788786 · Cited by 523
Self-citationTron, A. E., Belmonte, M. A., Adam, A., Aquila, B. M., Boise, L. H., Chiarparin, E., Cidado, J., Embrey, K. J., Gangl, E., Gibbons, F. D., et al. (2018) · Nature Communications · doi:10.1038/s41467-018-07551-w · Cited by 490
The BCL2 family: from apoptosis mechanisms to new advances in targeted therapy
Vogler, M., Braun, Y., Smith, V. M., Westhoff, M.-A., Pereira, R. S., Pieper, N. M., Anders, M., Callens, M., Vervliet, T., Abbas, M., et al. (2025) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-025-02176-0 · Cited by 462
The manipulation of apoptosis for cancer therapy using BH3-mimetic drugs
Diepstraten, S. T., Anderson, M. A., Czabotar, P. E., Lessene, G., Strasser, A., & Kelly, G. L. (2022) · Nature Reviews Cancer · doi:10.1038/s41568-021-00407-4 · Cited by 346
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Metadata
- Authors
- Davids, M. S., Roberts, A. W., Seymour, J. F., Pagel, J. M., Kahl, B. S., Wierda, W. G., Puvvada, S., Kipps, T. J., Anderson, M. A., Salem, A. H., Dunbar, M., Zhu, M., Peale, F., Ross, J. A., Gressick, L., Desai, M., Kim, S. Y., Verdugo, M., Humerickhouse, R. A., Gordon, G. B., & Gerecitano, J. F.
- Venue
- Journal of Clinical Oncology
- Published
- 2017-03-10
- Volume
- 35
- Issue
- 8
- Pages
- 826-833
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2582696216
- Cited by
- 748
- References
- 4
- FWCI
- 64.34
- Type
- journal article
- Language
- en
- Open access
- green
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- Davids, M. S., Roberts, A. W., Seymour, J. F., Pagel, J. M., Kahl, B. S., Wierda, W. G., Puvvada, S., Kipps, T. J., Anderson, M. A., Salem, A. H., Dunbar, M., Zhu, M., Peale, F., Ross, J. A., Gressick, L., Desai, M., Kim, S. Y., Verdugo, M., Humerickhouse, R. A., . . . Gerecitano, J. F. (2017). Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.70.4320
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