Population pharmacokinetics of obinutuzumab (GA101) in chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma and exposure-response in CLL

CPT: Pharmacometrics and Systems Pharmacology

Volumn 3, Issue 10, 2014, Pages

  Gibiansky, E ^a   Gibiansky, L ^a   Carlile, D J ^b   Jamois, C ^c   Buchheit, V ^c   Frey, N ^c  

^a QuantPharm LLC 49 Flints Grove Drive   (United States)

^b ROCHE PRODUCTS LTD   (United Kingdom)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CHLORAMBUCIL; CYCLOPHOSPHAMIDE; DOXORUBICIN; OBINUTUZUMAB; PREDNISONE; RITUXIMAB; VINCRISTINE;

ADULT; AGED; ARTICLE; BASELINE TUMOR SIZE; BODY WEIGHT; CHRONIC LYMPHATIC LEUKEMIA; DRUG CLEARANCE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GENDER; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; TUMOR VOLUME;

EID: 84925462844     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2014.42     Document Type: Article

References (45)

1. Coiffer, B. et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N. Engl. J. Med. 346, 235-242 (2002).
2. Coiffer, B. et al. Long-term outcome of patients in the LNH-98.5 trial, the frst randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. Blood 116, 2040-2045 (2010).
3. Pfreundschuh, M. et al.; MabThera International Trial Group. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet. Oncol. 7, 379-391 (2006).
4. Marcus, R. et al. CVP chemotherapy plus rituximab compared with CVP as frst-line treatment for advanced follicular lymphoma. Blood 105, 1417-1423 (2005).
5. Forstpointner, R. et al.; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fudarabine, cyclophosphamide, mitoxantrone (FCM) signifcantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood 104, 3064-3071 (2004).
6. Hiddemann, W. et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) signifcantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood 106, 3725-3732 (2005).
7. Schulz, H. et al. Immunochemotherapy with rituximab and overall survival in patients with indolent or mantle cell lymphoma: a systematic review and meta-analysis. J. Natl. Cancer Inst. 99, 706-714 (2007).
8. Herold, M. et al.; East German Study Group Hematology and Oncology Study. Rituximab added to frst-line mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma: an East German Study Group Hematology and Oncology Study. J. Clin. Oncol. 25, 1986-1992 (2007).
9. Salles, G. et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet 377, 42-51 (2011).
10. van Oers, M.H. et al. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J. Clin. Oncol. 28, 2853-2858 (2010).
11. Cheson, B.D. et al.; International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. Revised recommendations 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. 21, 4642-4649 (2003).
12. Hagemeister, F. Rituximab for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukaemia. Drugs 70, 261-272 (2010).
13. Keating, G.M. Rituximab: a review of its use in chronic lymphocytic leukaemia, low-grade or follicular lymphoma and diffuse large B-cell lymphoma. Drugs 70, 1445-1476 (2010).
14. Mössner, E. et al. Increasing the effcacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood 115, 4393-4402 (2010).
15. Niederfellner, G. et al. Epitope characterization and crystal structure of GA101 provide insights into the molecular basis for type I/II distinction of CD20 antibodies. Blood 118, 358-367 (2011).
16. Glennie, M.J., French, R.R., Cragg, M.S. & Taylor, R.P. Mechanisms of killing by anti-CD20 monoclonal antibodies. Mol. Immunol. 44, 3823-3837 (2007).
17. Morschhauser, F. et al. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J. Clin. Oncol. 27, 3346-3353 (2009).
18. Morschhauser, F. et al. Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma. Ann. Oncol. 21, 1870-1876 (2010).
19. Salles, G. et al. Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients. Blood 119, 5126-5132 (2012).
20. Sehn, L.H. et al. A phase 1 study of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed CD20-positive B-cell malignancies. Blood 119, 5118-5125 (2012).
21. Sehn, L.H. et al. Randomized phase II trial comparing GA101 (obinutuzumab) with rituximab in patients with relapsed CD20+ indolent B-cell non-Hodgkin lymphoma: preliminary analysis of GAUSS study. Blood 118, Abstract 269 (2011).
22. Morschhauser, F.A. et al. Obinutuzumab (GA101) monotherapy in relapsed/refractory diffuse large b-cell lymphoma or mantle-cell lymphoma: results from the phase II GAUGUIN study. J. Clin. Oncol. 31, 2912-2919 (2013).
23. Salles, G.A. et al. Obinutuzumab (GA101) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: results from the phase II GAUGUIN study. J. Clin. Oncol. 31, 2920-2926 (2013).
24. Radford, J. et al. Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). Blood 122, 1137-1143 (2013).
25. Goede, V. et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N. Engl. J. Med. 370, 1101-1110 (2014).
26. Beal, S.L., Sheiner, L.B., Boeckmann, A.J. & Bauer, R.J. NONMEM Users Guides. 1989-2011 (Icon Development Solutions, Ellicott City, Maryland, USA, 2011).
27. Gibiansky, L., Gibiansky, E. & Bauer, R. Comparison of Nonmem 7.2 estimation methods and parallel processing effciency on a target-mediated drug disposition model. J. Pharmacokinet. Pharmacodyn. 39, 17-35 (2012).
28. Levi, M. et al. Characterization of the time-varying clearance of rituximab in nonhodgkin's lymphoma patients using a population pharmacokinetic analysis. Abstract from The American Conference on Pharmacometrics, 2008. http://tucson2008.go-acop.org/pdfs/Levi.pdf. Accessed 2 July 2014.
29. Yin, A. et al. Population pharmacokinetics (PK) and association of PK and clinical outcomes of rituximab in patients with non-Hodgkin's lymphoma. J. Clin. Oncol. 28, Abstract e13108 (2010).
30. Li, J. et al. Population pharmacokinetics of rituximab in patients with chronic lymphocytic leukemia. J. Clin. Pharmacol. 52, 1918-1926 (2012).
31. Australian Government Department of Health and Ageing: Therapeutic Drugs Administration. Australian Public Assessment Report for Rituximab, December 2011. http://www.tga.gov.au/pdf/auspar/auspar-mabthera-111215.pdf. Accessed 2 July 2014.
32. Ginaldi, L., De Martinis, M., Matutes, E., Farahat, N., Morilla, R. & Catovsky, D. Levels of expression of CD19 and CD20 in chronic B cell leukaemias. J. Clin. Pathol. 51, 364-369 (1998).
33. Suková, V., Klabusay, M., Coupek, P., Brychtová, Y., Doubek, M. & Mayer, J. Density expression of the CD20 antigen on population of tumor cells in patients with chronic B-lymphocyte lymphoproliferative diseases. Cas. Lek. Cesk. 145, 712-6; discussion 716 (2006).
34. Prevodnik, V.K., Lavrenčak, J., Horvat, M. & Novakovič, B.J. The predictive signifcance of CD20 expression in B-cell lymphomas. Diagn. Pathol. 6, 33 (2011).
35. Ling, J., Zhou, H., Jiao, Q. & Davis, H.M. Interspecies scaling of therapeutic monoclonal antibodies: initial look. J. Clin. Pharmacol. 49, 1382-1402 (2009).
36. Molica, S. Sex differences in incidence and outcome of chronic lymphocytic leukemia patients. Leuk. Lymphoma 47, 1477-1480 (2006).
37. Kastbom, A. et al. Infuence of FCGR3A genotype on the therapeutic response to rituximab in rheumatoid arthritis: an observational cohort study. BMJ Open 2, (2012).
38. Kastbom, A., Ahmadi, A., Söderkvist, P. & Skogh, T. The 158V polymorphism of Fc gamma receptor type IIIA in early rheumatoid arthritis: increased susceptibility and severity in male patients (the Swedish TIRA project). Rheumatology (Oxford). 44, 1294-1298 (2005).
39. Mellor, J.D., Brown, M.P., Irving, H.R., Zalcberg, J.R. & Dobrovic, A. A critical review of the role of Fc gamma receptor polymorphisms in the response to monoclonal antibodies in cancer. J. Hematol. Oncol. 6, 1 (2013).
40. Ogura, M. et al. Phase I study of obinutuzumab (GA101) in Japanese patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Cancer Sci. 104, 105-110 (2013).
41. Karlsson, M.O. & Savic, R.M. Diagnosing model diagnostics. Clin. Pharmacol. Ther. 82, 17-20 (2007).
42. Yano, Y., Beal, S.L. & Sheiner, L.B. Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J. Pharmacokinet. Pharmacodyn. 28, 171-192 (2001).
43. Wang, D.D. & Zhang, S. Standardized visual predictive check versus visual predictive check for model evaluation. J. Clin. Pharmacol. 52, 39-54 (2012).
44. Bergstrand, M., Hooker, A.C., Wallin, J.E. & Karlsson, M.O. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 13, 143-151 (2011).
45. Mentré, F. & Escolano, S. Prediction discrepancies for the evaluation of nonlinear mixed-effects models. J. Pharmacokinet. Pharmacodyn. 33, 345-367 (2006).