Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer

Current Drug Metabolism

Volumn 13, Issue 7, 2012, Pages 911-922

  Lu, Dan ^a   Burris III, Howard A ^b   Wang, Bei ^a   Dees, E Claire ^c   Cortes, Javier ^d   Joshi, Amita ^a   Gupta, Manish ^a   Yi, Joo Hee ^a   Chu, Yu Waye ^a   Shih, Ted ^a   Fang, Liang ^a   Girish, Sandhya ^a  

^a GENENTECH INC   (United States)

^b SARAH CANNON RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

HER2; Metastatic breast cancer; Pertuzumab; Pharmacokinetics; Therapeutic protein drug interactions; Trastuzumab emtansine

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; PERTUZUMAB; TRASTUZUMAB EMTANSINE;

ADULT; AGED; ARTICLE; BREAST METASTASIS; CLINICAL ARTICLE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; FEMALE; HUMAN; LOADING DRUG DOSE; MAINTENANCE DRUG DOSE; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DRUG INTERACTIONS; FEMALE; HUMANS; MALE; MAYTANSINE; MIDDLE AGED; NEOPLASM METASTASIS; RECEPTOR, ERBB-2;

EID: 84865748679     PISSN: 13892002     EISSN: 18755453     Source Type: Journal    
DOI: 10.2174/138920012802138688     Document Type: Article

References (41)

1. Krop, I.E.; Beeram, M.; Modi, S.; Jones, S.F.; Holden, S.N.; Yu, W.; Girish, S.; Tibbitts, J.; Yi, J.H.; Sliwkowski, M.X.; Jacobson, F.; Lutzker, S.G.; Burris, H.A. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J. Clin. Oncol., 2010, 28(16), 2698-2704.
2. Lewis Phillips, G.D.; Li, G.; Dugger, D.L.; Crocker, L.M.; Parsons, K.L.; Mai, E.; Blättler, W.A.; Lambert, J.M.; Chari, R.V.; Lutz, R.J.; Wong, W.L.; Jacobson, F.S.; Koeppen, H.; Schwall, R.H.; Kenkare-Mitra, S.R.; Spencer, S.D.; Sliwkowski, M.X. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res., 2008, 68(22), 9280-9290.
3. Junttila, T.T.; Li, G.; Parsons, K.; Phillips, G.L.; Sliwkowski, M.X. Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensi-tive breast cancer. Breast Cancer. Res. Treat., 2011, 128(2), 347-356.
4. Burris, H.; Rugo, H.; Vukelka, S.; Vogel, C.L.; Borson, R.A.; Limentani, S.; Tan-Chiu, E.; Krop, I.E.; Michaelson, R.A.; Girish, S.; Amler, L.; Zheng, M.; Chu, Y.W.; Klencke, B.; O'Shaughnessy, J.A. Phase II study of the antibody drug conjugate trastuzumab-DM1 (T-DM1) for the treatment of HER2-positive breast cancer after prior HER2-directed therapy. J. Clin. Oncol., 2011, 29(4), 398-405.
5. Krop, I.; LoRusso, P.; Miller, K.D.; Modi, S.; Yardley, D.; Rodriguez, G.; Agresta, S.; Lu, M.; Zheng, M.; Amler, L.; Winer, E.; Rugo, H. Phase II study of trastuzumab-DM1 (T-DM1), a novel HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer who were previously treated with an anthracycline, a taxane, capecitabine, lapatinib, and trastuzumab (abstract 277O). Ann. Oncol., 2010, 21(suppl. 8), viii2.
6. Perez, E.A.; Dirix, L.; Kocsis, J.; Gianno, J.; Lu, J.; Vinholes, J.; Ng, V.; Linehan, C.; Agresta, S.; Hurvitz, S. Efficacy and safety of trastuzumab-DM1 versus trastuzumab plus docetaxel in HER2-positive metastatic breast cancer patients with no prior chemother-apy for metastatic disease: preliminary results of a randomized, multicenter, open-label phase 2 study (TDM4450G) (abstract LBA3). Ann. Oncol., 2010, 21(suppl. 8), viii2.
7. Franklin, M.C.; Carey, K.D.; Vajdos, F.F.; Leahy, D.J.; de Vos, A.M.; Sliwkowski, M.X. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell, 2004, 5(4), 317-328.
8. Adams, C.W.; Allison, D.E.; Flagella, K.; Presta, L.; Clarke, J.; Dybdal, N.; McKeever, K.; Sliwkowski, M.X. Humanization of a recombinant monoclonal antibody to produce a therapeutic HER dimerization inhibitor, pertuzumab. Cancer Immunol. Immunother., 2006, 55(5), 717-727.
9. Agus D.B.; Akita R.W.; Fox W.D.; Lewis G.D.; Higgins B.; Pisacane P.I.; Lofgren J.A.; Tindell C.; Evans D.P.; Maiese K.; Scher H.I.; Sliwkowski M.X. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell, 2002, 2(2), 127-137.
10. Agus, D.B.; Sweeney, C.J.; Morris, M.J.; Mendelson, D.S.; McNeel, D.G.; Ahmann, F.R.; Wang, J.; Derynck, M.K.; Ng, K.; Lyons, B.; Allison, D.E.; Kattan, M.W.; Scher, H.I. Efficacy and safety of single-agent pertuzumab (rhuMAb 2C4), a human epi-dermal growth factor receptor dimerization inhibitor, in castration-resistant prostate cancer after progression from taxane-based ther-apy. J. Clin. Oncol., 2007, 25(6), 675-681.
11. Herbst, R.S.; Davies, A.M.; Natale, R.B.; Dang, T.P.; Schiller, J.H.; Garland, L.L.; Miller, V.A.; Mendelson, D.; Van den Abbeele, A.D.; Melenevsky, Y.; de Vries, D.J.; Eberhard, D.A.; Lyons, B.; Lutzker, S.G.; Johnson, B.E. Efficacy and safety of single-agent pertuzumab, a human epidermal receptor dimerization inhibitor, in patients with non small cell lung cancer. Clin. Cancer Res., 2007, 13(20), 6175-6181.
12. Hubbard, S.R. EGF receptor inhibition: attacks on multiple fronts. Cancer Cell, 2005, 7(4), 287-288.
13. Friess T.; Scheuer W.; Hasmann M. Combination treatment with pertuzumab and trastuzumab against Calu-3 human NSCLC xenograft tumors is superior to monotherapy (abstract A51). Cancer Res., 2005, 46, 68-69.
14. Scheuer, W; Friess, T; Burtscher, H; Bossenmaier, B; Endl, J; Hasmann, M. Strongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor models. Cancer Res., 2009, 69(24), 9330-9336.
15. Baselga, J.; Gelmon, K.A.; Verma, S.; Wardley, A.; Conte, P.; Miles, D.; Bianchi, G.; Cortes, J.; McNally, V.A.; Ross, G.A.; Fu-moleau, P.; Gianni, L. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy. J. Clin. Oncol., 2010, 28(7), 1138-1144.
16. Fields, C.T.; Crocker, L.M.; Sliwkowski, M.X.; Lewis-Phillips, G.D. Dual targeting of HER2: enhanced anti-tumor efficacy of tras-tuzumab-DM1 combined with pertuzumab (abstract 5607). Cancer Res., 2010, 70(8 suppl), 1360.
17. Diéras, V.; Harbeck, N.; Albain, K.; Burris, H.; Awada, A.; Crivel-lari, D.; Andre, F.; Choi, Y.J.; Huang, J.; Miller, K.D. A phase Ib/II trial of trastuzumab-DM1 with pertuzumab for patients with HER2-positive, locally advanced or metastatic breast cancer: interim effi-cacy and safety results (abstract P3-14-01). Cancer Res., 2010, 70(24), 291s.
18. Miller, K.; Gianni, L.; Andre, F.; Dieras, V.; Mahtani, R.L.; Har-beck, N.; Huang, J.E.; Shih, T.; Choi, Y.; Burris III, H.A. A phase Ib/II trial of trastuzumab-DM1 (T-DM1) with pertuzumab (P) for women with HER2-positive, locally advanced or metastatic breast cancer (BC) who were previously treated with trastuzumab (T) (ab-stract 1012). J. Clin. Oncol., 2010, 28(15S), 117s.
19. Girish, S.; Martin, S.W.; Peterson, M.C.; Zhang, L.K.; Zhao, H.; Balthasar, J.; Evers, R.; Zhou, H.; Zhu, M.; Klunk, L.; Han, C.; Berglund, E.G.; Huang, S.M.; Joshi, A. AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development. A.A.P.S. J., 2011, 13(3), 405-416.
20. Ng, C.M.; Lum, B.L.; Gimenez, V.; Kelsey, S.; Allison, D. Ration-ale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis. Pharm. Res., 2006, 23(6), 1275-1284.
21. Gupta, M.; LoRusso, P.M.; Wang, B.; Yi J-H.; Burris, H.A. III; Beeram, M.; Modi, S.; Chu, Y-W.; Agresta, S.; Klencke, B.; Joshi, A.; Girish, S. Clinical implications of pathophysiological and demographic covariates on the population pharmacokinetics of trastuzumab-DM1, a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer. J. Clin. Pharmacol., DOI: 10.1177/0091270011403742. Published online: September 27, 2011.
22. Mandema, J.W.; Verotta, D.; Sheiner, L.B. Building population pharmacokinetic-pharmacodynamic models. I. Models for covari-ate effects. J. Pharmacokinet. Biopharm., 1992, 20(5), 511-528.
23. Jonsson, E.N.; Karlsson, M.O. Automated covariate model building within NONMEM. Pharm. Res., 1998, 15(9), 1463-1468.
24. US Department of Health and Human Services: Food and Drug Administration. Guidance for industry: population pharmacokinet-ics. 1999. Available at: http://www.fda.gov/downloads/ScienceRe search/SpecialTopics/ WomensHealthResearch/UCM133184.pdf [Accessed July 6, 2011].
25. Sheiner, L.B.; Rosenberg, B.; Marathe, V.V. Estimation of popula-tion characteristics of pharmacokinetic parameters from routine clinical data. J. Pharmacokinet. Biopharm., 1977, 5(5), 445-479.
26. Sheiner, L.B.; Beal, S.; Rosenberg, B.; Marathe, V.V. Forecasting individual pharmacokinetics. Clin. Pharmacol. Ther., 1979, 26(3), 294-305.
27. Gordon, M.S.; Matei, D.; Aghajanian, C.; Matulonis, U.A.; Brewer, M.; Fleming, G.F.; Hainsworth, J.D.; Garcia, A.A.; Pegram, M.D.; Schilder, R.J.; Cohn, D.E.; Roman, L.; Derynck, M.K.; Ng, K.; Ly-ons, B.; Allison, D.E.; Eberhard, D.A.; Pham, T.Q.; Dere, R.C.; Karlan, B.Y. Clinical activity of pertuzumab (rhuMAb 2C4), a HER dimerization inhibitor, in advanced ovarian cancer: potential predictive relationship with tumor HER2 activation status. J. Clin. Oncol., 2006, 24(26), 4324-4332.
28. Xin, Y.; Xu, L.; Bai, S.; Jumbe, N.; Allison, D. Fixed dosing evaluation of pertuzumab in cancer patients from phase I and II studies (abstract PIII-51). Clin. Pharmacol. Ther., 2010, 87(S1), S84.
29. Girish, S.; Gupta, M.; Wang, B.; Lu, D.; Krop, I.; Vogel, C.; Bur-ris, H.; Yi, J.; Saad, O.; Tong, B.; Klencke, B.; Agresta, S.; Chu, W.; Joshi, A. Clinical pharmacology of T-DM1: a novel anti-body-drug conjugate (ADC) in development for the treatment of HER2-positive (HER2+) cancer (abstract PI-11). Clin. Pharmacol. Ther., 2011, 89(suppl 1), S12.
30. US Department of Health and Human Services: Food and Drug Administration. Drug interaction studies\study design, data analy-sis, and implications for dosing and labeling. 2006. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegula toryInformation/Guidances/UCM072101.pdf [Accessed July 6, 2011].
31. Lee, J.I.; Zhang, L.; Men, A.Y.; Kenna, L.A.; Huang, S.M. CYP-mediated therapeutic protein-drug interactions: clinical findings, proposed mechanisms and regulatory implications. Clin. Pharma-cokinet., 2010, 49(5), 295-310.
32. Huang, S.M.; Zhao, H.; Lee, J.I.; Reynolds, K.; Zhang, L.; Temple, R.; Lesko, L.J. Therapeutic protein-drug interactions and implica-tions for drug development. Clin. Pharmacol. Ther., 2010, 87(4), 497-503.
33. Kuester, K.; Kloft, C. Pharmacokinetics of monoclonal antibodies. In: Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug Development, 6th ed.; Mei-bohm, B., Ed.; Wiley-VCH Verlag GmbH & Co. KGaA: Wein-heim, Germany, 2006; pp 45-92.
34. Shen, B.-Q.; Bumbaca, D.; Saad, O.; Yue, Q.; Pastuskovas, C.V.; Khojasteh, C.; Tibbitts, J.; Kaur, S.; Wang, B.; Chu, Y.-W.; Lo-Russo, P.M.; Girish, S. Metabolic fate and pharmacokinetic charac-terization of trastuzumab emtansine (T-DM1): an emphasis on pre-clinical and clinical catabolism (abstract PIII-72). Clin. Pharmacol. Ther., 2011, 89(S1), S90.
35. Morgan, E.T. Impact of infectious and inflammatory disease on cytochrome P450-mediated drug metabolism and pharmacokinet-ics. Clin. Pharmacol. Ther., 2009, 85(4), 434-438.
36. European Medicines Agency. International Conference on Harmonisation E 7 studies in support of special populations: geriatrics. 1994. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500002875.pdf [Accessed July 6, 2011].
37. European Medicines Agency. Note for guidance on the investiga-tion of drug interactions. 2008. Available at: http://www.ema.eu-ropa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500002966.pdf [Accessed July 6, 2011].
38. Duan, J.Z. Applications of population pharmacokinetics in current drug labelling. J. Clin. Pharm. Ther., 2007, 32(1), 57-79.
39. Zhu, Y.; Hu, C.; Lu, M.; Liao, S.; Marini, J.C.; Yohrling, J.; Yeild-ing, N.; Davis, H.M.; Zhou, H. Population pharmacokinetic model-ing of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J. Clin. Pharmacol., 2009, 49(2), 162-175.
40. Savic, R.M.; Karlsson, M.O. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. A.A.P.S. J., 2009, 11(3), 558-569.
41. Ellis, P.; Barrios, C.; Im, Y.H.; Patre, M.; Branle, F.; Perez, E.A. MARIANNE: a phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzu-mab (H) plus taxane for first-line treatment of HER2-positive, pro-gressive, or recurrent locally advanced or metastatic breast cancer (MBC) (abstract TPS102). J. Clin. Oncol., 2011, 29(15 suppl), 7s.