CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies

Journal of Clinical Pharmacology

Volumn 53, Issue 8, 2013, Pages 866-877

  Han, Tae H ^a   Gopal, Ajay K ^b   Ramchandren, Radhakrishnan ^c   Goy, Andre ^d   Chen, Robert ^e   Matous, Jeffrey V ^f   Cooper, Maureen ^g   Grove, Laurie E ^a   Alley, Stephen C ^a   Lynch, Carmel M ^a   O'connor, Owen A ^h  

^a SEATTLE GENETICS INC   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c KARMANOS CANCER INSTITUTE   (United States)

^d HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

^e CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^f Rocky Mountain Blood and Marrow Transplant Program   (United States)

^g St Francis Hospital and Medical Center   (United States)

^h Och Spine at New York Presbyterian Hospitals   (United States)

Author keywords

Biotechnology; Clinical pharmacology; Clinical trials; Drug metabolism; Oncology; Pharmacokinetics

Indexed keywords

BRENTUXIMAB VEDOTIN; CD30 ANTIGEN; CYTOCHROME P450 3A; KETOCONAZOLE; MIDAZOLAM; RIFAMPICIN; VEDOTIN;

ADOLESCENT; ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BRAIN HEMORRHAGE; CHILL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DRUG BLOOD LEVEL; DRUG EXCRETION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HEMATOLOGIC MALIGNANCY; HUMAN; HYPERTENSION; INFUSION RELATED REACTION; LEUKOCYTE COUNT; LIMIT OF QUANTITATION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PRURITUS; SIDE EFFECT; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

BIOTECHNOLOGY; CLINICAL PHARMACOLOGY; CLINICAL TRIALS; DRUG METABOLISM; ONCOLOGY; PHARMACOKINETICS;

ADOLESCENT; ADULT; AGED; ANTIGENS, CD30; ANTINEOPLASTIC AGENTS; CROSS-OVER STUDIES; CYTOCHROME P-450 CYP3A; DRUG INTERACTIONS; FECES; FEMALE; HEMATOLOGIC NEOPLASMS; HUMANS; IMMUNOCONJUGATES; KETOCONAZOLE; MALE; MIDAZOLAM; MIDDLE AGED; OLIGOPEPTIDES; RIFAMPIN; YOUNG ADULT;

EID: 84885042049     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.116     Document Type: Article

References (27)

1. Alley S, Oflazoglu E, Mechthild J, et al. Antibody-targeted delivery of auristatin using SGN-35 leads to one to two logs greater intratumoral auristatin concentrations than non-targeted therapy [abstract]. AACR Meet Abstr. 2009;2009:32-34.
2. Alley SC, Okeley NM, Senter PD. Antibody-drug conjugates: targeted drug delivery for cancer. Curr Opin Chem Biol. 2010;14:529-5537.
3. Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem. 2010;21:5-13.
4. Chiarle R, Podda A, Prolla G, Gong J, Thorbecker GJ, Inghirami G. CD30 in normal and neoplastic cells. Clin Immunol. 1999;90:157- 164. (Pubitemid 29162160)
5. Durkop H, Latza U, Hummel M, Eitelbach F, Seed B, Stein H. Molecular cloning and expression of a new member of the nerve growth factor receptor family that is characteristic for Hodgkin's disease. Cell. 1992;68:421-427.
6. Bartlett NL, Younes A, Carabasi MH, et al. A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30 hematologic malignancies. Blood. 2008;111: 1848-1854. (Pubitemid 351451492)
7. Wahl AF, Klussman K, Thompson JD, et al. The anti-CD30 monoclonal antibody SGN-30 promotes growth arrest and DNA fragmentation in vitro and affects antitumor activity in models of Hodgkin's disease. Cancer Res. 2002;62:3736-3742. (Pubitemid 34728855)
8. Doronina SO, Toki BE, Torgov MY, et al. Development of potent monoclonal antibody auristatin conjugates for cancer therapy. Nat Biotechnol. 2003;21:778-784. (Pubitemid 36791396)
9. Francisco JA, Cerveny CG, Meyer DL, et al. cAC10-vcMMAE, an anti-CD30-monomethyl auristatin E conjugate with potent and selective antitumor activity. Blood. 2003;102:1458- 1465. (Pubitemid 36988057)
10. Okeley NM, Miyamoto JB, Zhang X, et al. Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Clin Cancer Res. 2010;16:888-897.
11. Pro B, Advani R, Brice P, et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large cell lymphoma: results of a phase II study J Clin Oncol. 2012;30:2190- 2196.
12. Younes A, Gopal AK, Smith SE, et al. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012;30:2183-2189.
13. Younes A, Bartlett NL, Leonard JP, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010;363(19):1812-1821.
14. Fanale MA, Forero-Torres A, Rosenblatt JD, et al. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012;18:248-255.
15. Han TH, Kennedy D, Hayes S, Lynch CM. The pharmacokinetics of brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) [abstract]. Clin Pharmacol Ther. 2012;91(suppl 1):PII-1.
16. Dowell JA, Korth-Bradley J, Liu H, King SP, Berger MS. Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse. J Clin Pharmacol. 2001;41:1206-1214. (Pubitemid 32983219)
17. Girish S, Gupta M, Wang B, et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother Pharmacol. 2012;69:1229-1240.
18. Lapusan S, Vidriales MB, Thomas X, et al. Phase I studies of AVE9633, an anti-CD33 antibody-maytansinoid conjugate. In adult patients with relapsed/refractory acute myeloid leukemia. Invest New Drugs. 2012;30:1121-1131.
19. Shen BQ, Xu K, Liu L, et al. Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates. Nat Biotechnol. 2012. 30:184-189.
20. Huang SM, Zhao H, Lee JI, et al. Therapeutic protein-drug interactions and implications for drug development. Clin Pharmacol Ther. 2010;87:497-503.
21. Seitz K, Zhou H.H. Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies: reality check. J Clin Pharmacol. 2007;47:1104-1118.
22. ADCETRIS® [package insert]. Bothell, WA: Seattle Genetics, Inc.; 2012.
23. Mahmood I, Green, MD. Drug interaction studies of therapeutic proteins or monoclonal antibodies. J Clin Pharmacol. 2007;47:1540-1554. (Pubitemid 350115304)
24. Lu D, Krop I, Modi S, et al. Pharmacokinetics (PK) of trastuzumab- DM1 (T-DM1) and paclitaxel (T) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with a trastuzumab-containing regimen [abstract]. Cancer Res. 2010;70(24 Suppl.): P3-14-22.
25. Olkkola KT, Aranko K, Luurila H, et al. A potentially hazardous interaction between erythromycin and midazolam. Clin Pharmacol Ther. 1993;53:298-305. (Pubitemid 23094372)
26. Olkkola KT, Backman JT, Neuvonen PJ. Midazolam should be avoided in patients receiving the systemic antimycotics ketoconazole or itraconazole. Clin Pharmacol Ther. 1994;55:481-485. (Pubitemid 24192233)
27. Lin JH. Drug-drug interaction mediated by inhibition and induction of P-glycoprotein. Adv Drug Deliv Rev. 2003;55:53-81. (Pubitemid 36082882)