Venetoclax for the treatment of chronic lymphocytic leukemia

References

• Nabhan C, Rosen ST. Chronic lymphocytic leukemia: a clinical review. JAMA. 2014;312:2265–2276.
   PubMed Web of Science ®Google Scholar
• National Cancer Institute. Surveillance epidemiology and end results cancer statistics review. 2016. [cited 2016 Feb 27]. Available from: http://seer. cancer.gov/statfacts/html/clyl.html. Published: National Cancer Institute.
   Google Scholar
• Guieze R, Wu CJ. Genomic and epigenomic heterogeneity in chronic lymphocytic leukemia. Blood. 2015;126:445–453.
   PubMed Web of Science ®Google Scholar
• Brown JR, Hallek MJ, Pagel JM. Chemoimmunotherapy versus targeted treatment in chronic lymphocytic leukemia: when, how long, how much, and in which combination? Am Soc Clin Oncol Educ Book. 2016;35:e387–e398.
   PubMedGoogle Scholar
• Zenz T, Krober A, Scherer K, et al. Monoallelic TP53 inactivation is associated with poor prognosis in chronic lymphocytic leukemia: results from a detailed genetic characterization with long-term follow-up. Blood. 2008;112:3322–3329.
   PubMed Web of Science ®Google Scholar
• Hamblin TJ, Davis Z, Gardiner A, et al. Unmutated Ig V(H) genes are associated with a more aggressive form of chronic lymphocytic leukemia. Blood. 1999;94:1848–1854.
   PubMed Web of Science ®Google Scholar
• International CLLIPIWG. An international prognostic index for patients with chronic lymphocytic leukaemia (CLL-IPI): a meta-analysis of individual patient data. Lancet Oncol. 2016;17:779–790.
   PubMed Web of Science ®Google Scholar
• Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, Phase 3 trial. Lancet. 2010;376:1164–1174.
   PubMed Web of Science ®Google Scholar
• Fischer K, Bahlo J, Fink AM, et al. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016;127:208–215.
   PubMed Web of Science ®Google Scholar
• Thompson PA, Tam CS, O’Brien SM, et al. Fludarabine, cyclophosphamide, and rituximab treatment achieves long-term disease-free survival in IGHV-mutated chronic lymphocytic leukemia. Blood. 2016;127:303–309.
   PubMed Web of Science ®Google Scholar
• Eichhorst B, Fink A-M, Busch R, et al. First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2016;17:928–942.
   PubMed Web of Science ®Google Scholar
• Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370:1101–1110.
   PubMed Web of Science ®Google Scholar
• Hillmen P, Robak T, Janssens A, et al. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label Phase 3 trial. Lancet. 2015;385:1873–1883.
   PubMed Web of Science ®Google Scholar
• Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369:32–42.
   PubMed Web of Science ®Google Scholar
• Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373:2425–2437.
   PubMed Web of Science ®Google Scholar
• Byrd JC, Furman RR, Coutre SE, et al. Three-year follow-up of treatment-naïve and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015;125:2497–2506.
   PubMed Web of Science ®Google Scholar
• O’Brien S, Jones JA, Coutre SE, et al. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol. 2016;17:1409–1418.
   PubMed Web of Science ®Google Scholar
• Farooqui MZ, Valdez J, Martyr S, et al. Ibrutinib for previously untreated and relapsed or refractory chronic lymphocytic leukaemia with TP53 aberrations: a phase 2, single-arm trial. Lancet Oncol. 2015;16:169–176.
   PubMed Web of Science ®Google Scholar
• Brown JR, Byrd JC, Coutre SE, et al. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110δ, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014;123:3390–3397.
   PubMed Web of Science ®Google Scholar
• Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014;370:997–1007.
   PubMed Web of Science ®Google Scholar
• O’Brien SM, Lamanna N, Kipps TJ, et al. A phase 2 study of idelalisib plus rituximab in treatment-naïve older patients with chronic lymphocytic leukemia. Blood. 2015;126:2686–2694.
   PubMed Web of Science ®Google Scholar
• O’Brien SM, Furman RR, Coutre SE, et al. Five-year experience with single-agent ibrutinib in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic leukemia. Blood. 2016;128:233.
   Web of Science ®Google Scholar
• Shanafelt TD, Borah BJ, Finnes HD, et al. Impact of ibrutinib and idelalisib on the pharmaceutical cost of treating chronic lymphocytic leukemia at the individual and societal levels. J Oncol Pract. 2015;11:252–258.
   PubMed Web of Science ®Google Scholar
• Lampson BL, Kasar SN, Matos TR, et al. Idelalisib given front-line for treatment of chronic lymphocytic leukemia causes frequent immune-mediated hepatotoxicity. Blood. 2016;128:195–203.
   PubMed Web of Science ®Google Scholar
• Robertson LE, Plunkett W, McConnell K, et al. Bcl-2 expression in chronic lymphocytic leukemia and its correlation with the induction of apoptosis and clinical outcome. Leukemia. 1996;10:456–459.
   PubMed Web of Science ®Google Scholar
• Adams JM, Huang DC, Strasser A, et al. Subversion of the Bcl-2 life/death switch in cancer development and therapy. Cold Spring Harb Symp Quant Biol. 2005;70:469–477.
   PubMedGoogle Scholar
• Chen L, Willis SN, Wei A, et al. Differential targeting of prosurvival Bcl-2 proteins by their BH3- only ligands allows complementary apoptotic function. Mol Cell. 2005;17:393–403.
   PubMed Web of Science ®Google Scholar
• Wilson WH, O’Connor OA, Czuczman MS, et al. Navitoclax, a targeted high-affinity inhibitor of BCL-2, in lymphoid malignancies: a phase 1 dose-escalation study of safety, pharmacokinetics, pharmacodynamics, and antitumour activity. Lancet Oncol. 2010;11:1149–1159.
   PubMed Web of Science ®Google Scholar
• Mason KD, Carpinelli MR, Fletcher JI, et al. Programmed a nuclear cell death delimits platelet life span. Cell. 2007;128:1173–1186.
   PubMed Web of Science ®Google Scholar
• Roberts AW, Davids MS, Pagel JM, et al. Targeting BCL2 with venetoclax in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016;374:311–322.
   PubMed Web of Science ®Google Scholar
• Del Gaizo Moore V, Brown JR, Certo M, et al. Chronic lymphocytic leukemia requires BCL2 to sequester prodeath BIM, explaining sensitivity to BCL2 antagonist ABT-737. J Clin Invest. 2007;117:112–121.
   PubMed Web of Science ®Google Scholar
• Davids MS, Deng J, Wiestner A, et al. Decreased mitochondrial apoptotic priming underlies stroma-mediated treatment resistance in chronic lymphocytic leukemia. Blood. 2012;120:3501–3509.
   PubMed Web of Science ®Google Scholar
• Souers, A.J., Leverson JD, Boghaert ER, et al. ABT-199, a potent and selective BCL-2 inhibitor, achieves antitumor activity while sparing platelets. Nat Med. 2013;19:202–208.
   PubMed Web of Science ®Google Scholar
• Roberts AW, Ma S, Brander DM, et al. Determination of recommended phase 2 dose of ABT-199 (GDC-0199) combined with rituximab (R) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Blood. 2014;124:325.
   Web of Science ®Google Scholar
• Choo EF, Boggs J, Zhu C, et al. The role of lymphatic transport on the systemic bioavailability of the Bcl-2 protein family inhibitors navitoclax (ABT-263) and ABT-199. Drug Metab Dispos. 2014;42:207–212.
   PubMed Web of Science ®Google Scholar
• Weiss J, Gajek T, Köhler BC, et al. Venetoclax (ABT-199) might act as a perpetrator in pharmacokinetic drug-drug interactions. Pharmaceutics. 2016;8:E5.
   PubMed Web of Science ®Google Scholar
• AbbVie Inc. Venclexta (venetoclax) [package insert]. North Chicago, IL: AbbVie Inc; 2016.
   Google Scholar
• Stilgenbauer S, Eichhorst B, Schetelig J, et al. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, Phase 2 study. Lancet Oncol. 2016;17:768–778.
   PubMed Web of Science ®Google Scholar
• Jones J, Choi M, Mato A, et al. Venetoclax (VEN) monotherapy for patients with chronic lymphocytic leuekmia (CLL) who relapse after or were refractory to ibrutinib or idelalisib. Blood. 2016; 128:637 (abstract).
   Web of Science ®Google Scholar
• Seymour JF, Ma S, Brander DM, et al. Venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukaemia: a Phase 1b study. Lancet Oncol. 2017;18:230–240.
   PubMed Web of Science ®Google Scholar
• Flinn I, Brunvand M, Choi M, et al. Safety and efficacy of a combination of venetoclax (GDC-0199/ABT-199) and obinutuzumab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia - results from a phase 1b study (GP28331). Blood. 2015;126:494.
   PubMed Web of Science ®Google Scholar
• Fischer K, Al-Sawaf O, Fink AM, et al. Safety and efficacy of venetoclax and obinutuzumab in patients with previously untreated chronic lymphocytic leukemia (CLL) and coexisting medical conditions: final results of the run-in phase of the randomized CLL14 trial (BO25323. Blood. 2016;128:2054 abstract.
   Web of Science ®Google Scholar
• Stilgenbauer S, Morschhauser F, Wendtner CM, et al. Phase Ib study (GO28440) of venetoclax with bendamustine/rituximab or bendamustine/obinutuzumab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia. Blood. 2016;128:4393 abstract.
   Web of Science ®Google Scholar
• Jones WJ, Woyach J, Awan F, et al. Phase 1B results of a Phase 1b/2 study of obinutuzumab, ibrutinib, and venetoclax in relapsed/refractory chronic lymphocytic leukemia (CLL). Blood. 2016;128:639 abstract.
   Web of Science ®Google Scholar
• Anderson MA, Deng J, Seymour JF, et al. The BCL2 selective inhibitor venetoclax induces rapid onset apoptosis of CLL cells in patients via a TP53-independent mechanism. Blood. 2016;127:3215–3224.
   PubMed Web of Science ®Google Scholar
• Mato AR, Hill BT, Lamanna N, et al. Optimal sequencing of ibrutinib, idelalisib, and venetoclax in chronic lymphocytic leukemia: results from a multicenter study of 683 patients. Ann Oncol. 2017;28:1050–1056.
   PubMed Web of Science ®Google Scholar
• Cramer P, Tresckow J, Bahlo J, et al. Low incidence of tumor lysis syndromes (TLS) and infusion related reactions (IRR) in the CLL2-BAG trial evaluating a sequential treatment of bendamustine (B), obinutuzumab (GA101, G), and venetoclax (ABT-199, A) in patients with chronic lymphocytic leukemia (CLL): interim safety results of a Phase-II-trial of the German CLL study group (GCLLSG). Blood. 2016;128:2044 abstract.
   Web of Science ®Google Scholar
• Davids MS, Gerecitano J, Potluri J, et al. Integrated safety analysis of venetoclax monotherapy in chronic lymphocytic leukemia (CLL). Haematologica. 2016;101:59 abstract.
   Web of Science ®Google Scholar