4,421
Views
29
CrossRef citations to date
0
Altmetric
Original Articles

Safety and efficacy of navitoclax, a BCL-2 and BCL-XL inhibitor, in patients with relapsed or refractory lymphoid malignancies: results from a phase 2a study

, , , , , , , & show all
Pages 810-818 | Received 11 Mar 2020, Accepted 26 Oct 2020, Published online: 25 Nov 2020

References

  • Lindsten T, Ross AJ, King A, et al. The combined functions of proapoptotic Bcl-2 family members bak and bax are essential for normal development of multiple tissues. Mol Cell. 2000;6(6):1389–1399.
  • Adams JM, Cory S. Life-or-death decisions by the Bcl-2 protein family. Trends Biochem Sci. 2001;26(1):61–66.
  • Wei MC, Zong WX, Cheng EH, et al. Proapoptotic BAX and BAK: a requisite gateway to mitochondrial dysfunction and death. Science. 2001;292(5517):727–730.
  • Degenhardt K, Sundararajan R, Lindsten T, et al. Bax and Bak independently promote cytochrome c release from mitochondria. J Biol Chem. 2002;277(16):14127–14134.
  • Tsujimoto Y, Cossman J, Jaffe E, et al. Involvement of the bcl-2 gene in human follicular lymphoma. Science. 1985;228(4706):1440–1443.
  • Pettersson M, Jernberg-Wiklund H, Larsson LG, et al. Expression of the bcl-2 gene in human multiple myeloma cell lines and normal plasma cells. Blood. 1992;79(2):495–502.
  • Marschitz I, Tinhofer I, Hittmair A, et al. Analysis of Bcl-2 protein expression in chronic lymphocytic leukemia. A comparison of three semiquantitation techniques. Am J Clin Pathol. 2000;113(2):219–229.
  • Agarwal B, Naresh KN. Bcl-2 family of proteins in indolent B-cell non-Hodgkin's lymphoma: study of 116 cases. Am J Hematol. 2002;70(4):278–282.
  • Minn AJ, Rudin CM, Boise LH, et al. Expression of bcl-xL can confer a multidrug resistance phenotype. Blood. 1995;86(5):1903–1910.
  • 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.
  • Amundson SA, Myers TG, Scudiero D, et al. An informatics approach identifying markers of chemosensitivity in human cancer cell lines. Cancer Res. 2000;60(21):6101–6110.
  • Adams JM, Cory S. The Bcl-2 apoptotic switch in cancer development and therapy. Oncogene. 2007;26(9):1324–1337.
  • Certo M, Del Gaizo Moore V, Nishino M, et al. Mitochondria primed by death signals determine cellular addiction to antiapoptotic BCL-2 family members. Cancer Cell. 2006;9(5):351–365.
  • Ghielmini M. Follicular lymphoma. Ann Oncol. 2010;21:vii151–vii153.
  • Tse C, Shoemaker AR, Adickes J, et al. ABT-263: a potent and orally bioavailable Bcl-2 family inhibitor. Cancer Res. 2008;68(9):3421–3428.
  • 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(12):1149–1159.
  • Roberts AW, Seymour JF, Brown JR, et al. Substantial susceptibility of chronic lymphocytic leukemia to BCL2 inhibition: results of a phase I study of navitoclax in patients with relapsed or refractory disease. J Clin Oncol. 2012;30(5):488–496.
  • Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17(4):1244.
  • Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored working group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87(12):4990–4997.
  • Zhang H, Nimmer PM, Tahir SK, et al. Bcl-2 family proteins are essential for platelet survival. Cell Death Differ. 2007;14(5):943–951.
  • Mason KD, Carpinelli MR, Fletcher JI, et al. Programmed anuclear cell death delimits platelet life span. Cell. 2007;128(6):1173–1186.
  • Chipuk JE, Fisher JC, Dillon CP, et al. Mechanism of apoptosis induction by inhibition of the anti-apoptotic BCL-2 proteins. Proc Natl Acad Sci U S A. 2008;105(51):20327–20332.
  • Seymour F, Roberts A, Carney D, et al. Phase-II study of navitoclax (ABT-263) safety and efficacy in patients with relapsed or refractory chronic lymphocytic leukemia (CLL): interim results. Haematologica. 2011;96(suppl 2:227.
  • Ackler S, Mitten MJ, Foster K, et al. The Bcl-2 inhibitor ABT-263 enhances the response of multiple chemotherapeutic regimens in hematologic tumors in vivo. Cancer Chemother Pharmacol. 2010;66(5):869–880.
  • Chen J, Jin S, Abraham V, et al. The Bcl-2/Bcl-X(L)/Bcl-w inhibitor, navitoclax, enhances the activity of chemotherapeutic agents in vitro and in vivo. Mol Cancer Ther. 2011;10(12):2340–2349.
  • Ackler S, Mitten MJ, Chen J, et al. Navitoclax (ABT-263) and bendamustine ± rituximab induce enhanced killing of non-Hodgkin’s lymphoma tumours in vivo. Br J Pharmacol. 2012;167(4):881–891.
  • Kipps TJ, Eradat H, Grosicki S, et al. A phase 2 study of the BH3 mimetic BCL2 inhibitor navitoclax (ABT-263) with or without rituximab, in previously untreated B-cell chronic lymphocytic leukemia. Leuk Lymphoma. 2015;56(10):2826–2833.
  • Roberts AW, Advani RH, Kahl BS, et al. Phase 1 study of the safety, pharmacokinetics, and antitumour activity of the BCL2 inhibitor navitoclax in combination with rituximab in patients with relapsed or refractory CD20+ lymphoid malignancies. Br J Haematol. 2015;170(5):669–678.
  • Souers AJ, 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(2):202–208.
  • U.S. Food and Drug Administration. News & Events. FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality. 2016. [cited 2019 Mar 28]. Available from: https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm610308.htm.
  • Genentech. Genentech announces FDA approval for Venclexta plus Rituxan for people with previously treated chronic lymphocytic leukemia. 2018. [cited 2019 Mar 28]. Available from: https://www.gene.com/media/press-releases/14728/2018-06-08/genentech-announces-fda-approval-for-ven.
  • U.S. Food and Drug Administration. Drugs. FDA approves venetoclax for CLL and SLL. 2019. [cited 2019 Nov 11]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-cll-and-sll.
  • U.S. Food and Drug Administration. Drugs. FDA approves venetoclax in combination for AML in adults. 2018. [cited 2019 Mar 28]. Available from: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626499.htm.
  • Davids MS, Roberts AW, Seymour JF, et al. Phase I first-in-human study of venetoclax in patients with relapsed or refractory non-Hodgkin lymphoma. J Clin Oncol. 2017;35(8):826–833.
  • de Vos S, Swinnen LJ, Wang D, et al. Venetoclax, bendamustine, and rituximab in patients with relapsed or refractory NHL: a phase Ib dose-finding study. Ann Oncol. 2018;29(9):1932–1938.
  • Morschhauser F, Feugier P, Flinn IW, et al. Venetoclax plus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) improves outcomes in BCL2-positive first-line diffuse large B-cell lymphoma (DLBCL): First safety, efficacy and biomarker analyses from the phase II CAVALLI study. Blood. 2018;132(Supplement 1):782–782.
  • Alexander T, Lacayo NJ, Pullarkat VA, et al. Venetoclax and navitoclax in patients with relapsed or refractory acute lymphoblastic leukemia and lymphoblastic lymphoma. Blood. 2018;132(Supplement 1):3966–3966.
  • Agarwal R, Chan Y-C, Tam CS, et al. Dynamic molecular monitoring reveals that SWI-SNF mutations mediate resistance to ibrutinib plus venetoclax in mantle cell lymphoma. Nat Med. 2019;25(1):119–129.
  • Choudhary GS, Al-Harbi S, Mazumder S, et al. MCL-1 and BCL-xL-dependent resistance to the BCL-2 inhibitor ABT-199 can be overcome by preventing PI3K/AKT/mTOR activation in lymphoid malignancies. Cell Death Dis. 2015;6:e1593.
  • Del Gaizo Moore V, Letai A. BH3 profiling–measuring integrated function of the mitochondrial apoptotic pathway to predict cell fate decisions. Cancer Lett. 2013;332(2):202–205.