Intracellular-signaling tumor-regression modeling of the pro-apoptotic receptor agonists dulanermin and conatumumab

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 39, Issue 5, 2012, Pages 577-590

  Kay, Brittany P ^a   Hsu, Cheng Pang ^b   Lu, Jian Feng ^b   Sun, Yu Nien ^b   Bai, Shuang ^c   Xin, Yan ^c   D'Argenio, David Z ^a  

^a University of Southern California   (United States)

^b AMGEN INC   (United States)

^c GENENTECH INC   (United States)

Author keywords

Conatumumab; Death receptor activation of NF jB; Dulanermin; Extrinsic apoptotic pathway; Pro apoptotic receptor agonists; Tumorregression modeling

Indexed keywords

CONATUMUMAB; DULANERMIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; APOPTOSIS; ARTICLE; BLOOD SAMPLING; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CYTOTOXICITY; DRUG EFFICACY; DRUG RESPONSE; FEMALE; INTRACELLULAR SIGNALING; MATHEMATICAL MODEL; MOUSE; NONHUMAN; PREDICTION; PRIORITY JOURNAL; REGRESSION ANALYSIS; SINGLE DRUG DOSE; SURVIVAL FACTOR; TUMOR VOLUME; TUMOR XENOGRAFT; UPREGULATION;

ANIMALS; ANTIBODIES, MONOCLONAL; APOPTOSIS; APOPTOSIS REGULATORY PROTEINS; CELL LINE, TUMOR; FEMALE; HUMANS; INTRACELLULAR FLUID; MICE; MICE, NUDE; MODELS, BIOLOGICAL; RANDOM ALLOCATION; RATS; REMISSION INDUCTION; SIGNAL TRANSDUCTION; TNF-RELATED APOPTOSIS-INDUCING LIGAND; XENOGRAFT MODEL ANTITUMOR ASSAYS;

EID: 84870442016     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-012-9269-x     Document Type: Article

References (38)

1. Ashkenazi A (2008) Directing cancer cells to self-destruct with pro-apoptotic receptor agonists. Nat Rev Drug Discov 7:1001-1012
2. Bouralexis S, Findlay DM, Evdokiou A (2005) Death to the bad guys: targeting cancer via Apo2L/TRAIL. Apoptosis 10:35-51
3. Weinberg RA (2007) The biology of cancer. Garland Science, New York
4. Herbst RS, Eckhardt SG, Kurzrock R, Ebbinghaus S, O'Dwyer PJ, Gordon MS, Novotny W, Goldwasser MA, Tohnya TM, Lum BL, Ashkenazi A, Jubb AM, Mendelson DS (2010) Phase I doseescalation study of recombinant human Apo2L/TRAIL, a dual proapoptotic receptor agonist, in patients with advanced cancer. J Clin Oncol 28:2839-2846
5. Bajaj M, Heath EI (2011) Conatumumab: a novel monoclonal antibody against death receptor 5 for the treatment of advanced malignancies in adults. Expert Opin Biol Ther 11:1519-1524
6. Holland PM (2011) Targeting Apo2L/TRAIL receptors by soluble Apo2L/TRAIL. Cancer Lett. doi:10.1016/j.canlet.2010.11.001
7. Sharma S, de Vries E, Infante J, Oldenhuis C, Chiang L, Bilic S, Goldbrunner M, Scott J, Burris H (2008) Phase I trial of LBY135, a monoclonal antibody agonist to DR5, alone and in combination with capecitabine in advanced solid tumors. J Clin Oncol 26:3538
8. Trarbach T, Moehler M, Heinemann V, Kohne CH, Przyborek M, Schulz C, Sneller V, Gallant G, Kanzler S (2010) Phase II trial of mapatumumab, a fully human agonistic monoclonal antibody that targets and activates the tumour necrosis factor apoptosisinducing ligand receptor-1 (TRAIL-R1), in patients with refractory colorectal cancer. Br J Cancer 102:506-512
9. Sikic B, Wakelee H, von Mehren M, Lewis N, Calvert A, Plummer E, Fox N, Howard T, Jones S, Burris H (2007) A phase Ib study to assess the safety of lexatumumab, a human monoclonal antibody that activates TRAIL-R2, in combination with gemcitabine, pemetrexed, doxorubicin or FOLFIRI. J Clin Oncol 25:14006
10. Almasan A, Ashkenazi A (2003) Apo2L/TRAIL: apoptosis signaling, biology, and potential for cancer therapy. Cytokine Growth Factor Rev 14:337-348
11. LeBlanc HN, Ashkenazi A (2003) Apo2L/TRAIL and its death and decoy receptors. Cell Death Differ 10:66-75
12. Kaplan-Lefko PJ, Graves JD, Zoog SJ, Pan Y, Wall J, Branstetter DG, Moriguchi J, Coxon A, Huard JN, Xu R, Peach ML, Juan G, Kaufman S, Chen Q, Bianchi A, Kordich JJ, Ma M, Foltz IN, Gliniak BC (2010) Conatumumab, a fully human agonist antibody to death receptor 5, induces apoptosis via caspase activation in multiple tumor types. Cancer Biol Ther 9:618-631
13. Albeck JG, Burke JM, Aldridge BB, Zhang M, Lauffenburger DA, Sorger PK (2008) Quantitative analysis of pathways controlling extrinsic apoptosis in single cells. Mol Cell 30:11-25
14. Fussenegger M, Bailey JE, Varner J (2000) A mathematical model of caspase function in apoptosis. Nat Biotechnol 18: 768-774
15. Harrold J, Straubinger RM, Mager D (2012) Combinatorial chemotherapeutic efficacy in non-Hodgkin lymphoma can be predicted by a signaling model of CD20 pharmacodynamics. Cancer Res 72:1632-1641
16. Kelley SK, Harris LA, Xie D, Deforge L, Totpal K, Bussiere J, Fox JA (2001) Preclinical studies to predict the disposition of Apo2L/tumor necrosis factor-related apoptosis-inducing ligand in humans: characterization of in vivo efficacy, pharmacokinetics, and safety. J Pharmacol Exp Ther 299:31-38
17. Bruno R, Lu JF, Sun N, Claret L (2011) A modeling and simulation framework to support early clinical drug development decisions in oncology. J Clin Pharmacol 51:6-8
18. SimeoniM,Magni P, Cammia C, De Nicolao G, Croci V, Pesenti E, Germani M, Poggesi I, Rocchetti M (2004) Predictive pharmacokinetic- pharmacodynamic modeling of tumor growth kinetics in xenograft models after administration of anticancer agents. Cancer Res 64:1094-1101
19. Yang J, Mager DE, Straubinger RM (2010) Comparison of two pharmacodynamic transduction models for the analysis of tumor therapeutic responses in model systems. AAPS J 12:1-10
20. Yamazaki S, Skaptason J, Romero D, Lee JH, Zou HY, Christensen JG, Koup JR, Smith BJ, Koudriakova T (2008) Pharmacokinetic- pharmacodynamic modeling of biomarker response and tumor growth inhibition to an orally available cMet kinase inhibitor in human tumor xenograft mouse models. Drug Metab Dispos 36:1267-1274
21. D'Argenio DZ, Schumitzky A, Wang X (2009) ADAPT 5 user's guide: pharmacokinetic/pharmacodynamic systems analysis software. Biomedical Simulations Resource, Los Angeles
22. Schumitzky A (1995) EM Algorithms and two stage methods in pharmacokinetic population analysis. In: D'Argenio DZ (ed) Advanced methods of pharmacokinetic and pharmacodynamic systems analysis, vol 2. Plenum Press, New York, pp 140-160
23. Walker S (1996) An EM algorithm for nonlinear random effects models. Biometrics 52:934-944
24. Bauer RJ, Guzy S (2004) Monte Carlo parameter expectation maximization (MC-PEM) method for analyzing population pharmacokinetic/pharmacodynamic data. In: D'Argenio DZ (ed) Advanced methods of pharmacokinetic and pharmacodynamic systems analysis, vol 3. Kluwer Academic Publishers, Boston, pp 155-163
25. Chaudhary PM, Eby M, Jasmin A, Bookwalter A, Murray J, Hood L (1997) Death receptor 5, a new member of the TNFR family, and DR4 induce FADD-dependent apoptosis and activate the NF-kappaB pathway. Immunity 7:821-830
26. Hsu H, Shu HB, Pan MG, Goeddel DV (1996) TRADD-TRAF2 and TRADD-FADD interactions define two distinct TNF receptor 1 signal transduction pathways. Cell 84:299-308
27. Schneider P, Thome M, Burns K, Bodmer JL, Hofmann K, Kataoka T, Holler N, Tschopp J (1997) TRAIL receptors 1 (DR4) and 2 (DR5) signal FADD-dependent apoptosis and activate NFkappaB. Immunity 7:831-836
28. Micheau O, Lens S, Gaide O, Alevizopoulos K, Tschopp J (2001) NF-kappaB signals induce the expression of c-FLIP. Mol Cell Biol 21:5299-5305
29. Salvesen GS, Duckett CS (2002) IAP proteins: blocking the road to death's door. Nat Rev Mol Cell Biol 3:401-410
30. Choi YE, Butterworth M, Malladi S, Duckett CS, Cohen GM, Bratton SB (2009) The E3 ubiquitin ligase cIAP1 binds and ubiquitinates caspase-3 and -7 via unique mechanisms at distinct steps in their processing. J Biol Chem 284:12772-12782
31. Dreher MR, Liu W, Michelich CR, Dewhirst MW, Yuan F, Chilkoti A (2006) Tumor vascular permeability, accumulation, and penetration of macromolecular drug carriers. J Natl Cancer Inst 98:335-344
32. Curnis F, Sacchi A, Corti A (2002) Improving chemotherapeutic drug penetration in tumors by vascular targeting and barrier alteration. J Clin Invest 110:475-482
33. Sugahara KN, Teesalu T, Karmali PP, Kotamraju VR, Agemy L, Greenwald DR, Ruoslahti E (2010) Coadministration of a tumorpenetrating peptide enhances the efficacy of cancer drugs. Science 328:1031-1035
34. Jain RK (1994) Barriers to drug delivery in solid tumors. Sci Am 271:58-65
35. Minchinton AI, Tannock IF (2006) Drug penetration in solid tumours. Nat Rev Cancer 6:583-592
36. Albeck JG, Burke JM, Spencer SL, Lauffenburger DA, Sorger PK (2008) Modeling a snap-action, variable-delay switch controlling extrinsic cell death. PLoS Biol 6:2831-2852
37. Vanhoefer U, Harstrick A, Achterrath W, Cao S, Seeber S, Rustum YM (2001) Irinotecan in the treatment of colorectal cancer: clinical overview. J Clin Oncol 19:1501-1518
38. Daniel D, Yang B, Lawrence DA, Totpal K, Balter I, Lee WP, Gogineni A, Cole MJ, Yee SF, Ross S, Ashkenazi A (2007) Cooperation of the proapoptotic receptor agonist rhApo2L/TRAIL with the CD20 antibody rituximab against non-Hodgkin lymphoma xenografts. Blood 110:4037-4046