Phase i studies of AVE9633, an anti-CD33 antibody-maytansinoid conjugate, in adult patients with relapsed/refractory acute myeloid leukemia

Investigational New Drugs

Volumn 30, Issue 3, 2012, Pages 1121-1131

  Lapusan, Simona ^a   Vidriales, Maria B ^b   Thomas, Xavier ^c   De Botton, Stephane ^d   Vekhoff, Anne ^a   Tang, Ruoping ^a   Dumontet, Charles ^c   Morariu Zamfir, Rodica ^e   Lambert, John M ^f   Ozoux, Marie Laure ^e   Poncelet, Philippe ^g   San Miguel, Jesus F ^b   Legrand, Ollivier ^a,h   DeAngelo, Daniel J ⁱ   Giles, Francis J ^j   Marie, Jean Pierre ^a,h  

^a HÔPITAL SAINT ANTOINE   (France)

^b HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

^c EDOUARD HERRIOT HOSPITAL   (France)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e SANOFI   (France)

^f IMMUNOGEN INC   (United States)

^g Biocytex   (France)

^h SORBONNE UNIVERSITÉ   (France)

ⁱ DANA FARBER CANCER INSTITUTE   (United States)

^j University of Texas Health Science Center at San Antonio   (United States)

more..

Author keywords

Acute myeloid leukemia; Antibody drug conjugate; Maytansine; Pharmacodynamic; Pharmacokinetic

Indexed keywords

ANTINEOPLASTIC AGENT; AVE 9633; CD33 ANTIGEN; MEMBRANE ANTIGEN; PROTEIN DM4; UNCLASSIFIED DRUG;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BRONCHOSPASM; CANCER CHEMOTHERAPY; CANCER RELAPSE; CELL KINETICS; CHEMOTHERAPY INDUCED ANEMIA; CHILL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; EDEMA; ERYTHEMA; FEMALE; HEADACHE; HUMAN; HUMAN CELL; HYPOTENSION; HYPOXIA; IMMUNOGENICITY; KERATITIS; LEUKOCYTE; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RIGOR; THORAX PAIN;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD; ANTIGENS, DIFFERENTIATION, MYELOMONOCYTIC; ANTINEOPLASTIC AGENTS; BRONCHIAL SPASM; DRUG HYPERSENSITIVITY; FEMALE; HUMANS; IMMUNOCONJUGATES; INFUSIONS, INTRAVENOUS; LEUKEMIA, MYELOID, ACUTE; MALE; MAYTANSINE; MIDDLE AGED; SIALIC ACID BINDING IG-LIKE LECTIN 3;

EID: 84862162222     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-011-9670-0     Document Type: Article

References (16)

1. Shipley JL, Butera JN (2009) Acute myelogenous leukemia. Exp Hematol 37:649-58
2. Dombret H, Raffoux E, Gardin C (2008) Acute myeloid leukemia in the elderly Semin Oncol 35:430-8
3. Advani AS, Hunger SP, Burnett AK (2009) Acute leukemia in adolescents and young adults. Semin Oncol 36(3):213-26
4. Kreitman RJ (2009) Recombinant immunotoxins for the treatment of chemoresistant hematologic malignancies. Curr Pharm Des 15:2652-64
5. Legrand O, Perrot JY, Baudard M et al (2000) The immunophe-notype of 177 adults with acute myeloid leukemia: proposal of a prognostic score. Blood 96(3):870-7 (Pubitemid 30616850)
6. Sievers EL, Appelbaum FR, Spielberger RT et al (1999) Selective ablation of acute myeloid leukemia using antibody-targeted chemotherapy: a phase I study of an anti-CD33 calicheamicin immunoconjugate. Blood 93:3678-84 (Pubitemid 29249814)
7. Issell BF, Crook ST (1978) Maytansine. Cancer Treat Rev5:199-207 (Pubitemid 9109517)
8. Kupchan SM, Komoda Y, Court WA et al (1972) Maytansine, a novel antileukemic ansa macrolide from Maytenus ovatus. J Am Chem Soc 94:1354-6
9. Remillard S, Rebhun LI, Howie GA, Kupchan SM (1975) Antimitotic activity of the potent tumor inhibitor maytansine. Science 189(4207):1002-5
10. Chari RV, Xie H, Leece BA et al (2005) Preclinical evaluation of an anti-CD33-maytansinoid immunoconjugate, huMy9-6-DM4 (AVE9633) for the targeted therapy of acute myeloid leukemia. AACR; Abst #LB-287
11. Lin CM, Hanzel E, Wolpert-Defilip MK (1981) Binding of maytansine to tubulin: competition with other mitotic inhibitors. Chem Pathol Pharmacol 31:443-451 (Pubitemid 11056741)
12. Cheson BD, Bennett JM, Kopecky KJ (2003) Revised recom-mendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol 24:4642-4649 (Pubitemid 46594039)
13. Erickson HK, Park PU, Widdison WC, Kovtun YV et al (2006) Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing. Cancer Res 66:4426-4433
14. Parker SW, Lamri N, Simeoni LA (2003) Analysis of P-glycoprotein-mediated membrane transport in human peripheral blood lymphocytes using the UIC2 shift assay Cytom A 53:67-78 (Pubitemid 37522522)
15. Tang R, Cohen S, Perrot JY et al (2009) P-gp activity is a critical resistance factor against AVE9633 and DM4 cytotoxicity in leukaemia cell lines, but not a major mechanism of chemo-resistance in cells from acute myeloid leukaemia patients. BMC Cancer 9:199-203
16. Vidriales MB, Orfao A, Lopez-Berges MC et al (1995) Prognostic value ofS-phase cells in AML patients. Br J Haematol 89:342-348