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[Cancer Research 64, 7099-7109, October 1, 2004]
© 2004 American Association for Cancer Research

Regular Articles

BAY 43-9006 Exhibits Broad Spectrum Oral Antitumor Activity and Targets the RAF/MEK/ERK Pathway and Receptor Tyrosine Kinases Involved in Tumor Progression and Angiogenesis

Scott M. Wilhelm1, Christopher Carter1, LiYa Tang1, Dean Wilkie1, Angela McNabola1, Hong Rong1, Charles Chen1, Xiaomei Zhang1, Patrick Vincent1, Mark McHugh1, Yichen Cao1, Jaleel Shujath1, Susan Gawlak1, Deepa Eveleigh1, Bruce Rowley1, Li Liu1, Lila Adnane1, Mark Lynch1, Daniel Auclair1, Ian Taylor1, Rich Gedrich1, Andrei Voznesensky1, Bernd Riedl1, Leonard E. Post2, Gideon Bollag2 and Pamela A. Trail1

1 Bayer Pharmaceuticals Corporation, West Haven, Connecticut; and 2 Onyx Pharmaceuticals, Richmond, California

The RAS/RAF signaling pathway is an important mediator of tumor cell proliferation and angiogenesis. The novel bi-aryl urea BAY 43-9006 is a potent inhibitor of Raf-1, a member of the RAF/MEK/ERK signaling pathway. Additional characterization showed that BAY 43-9006 suppresses both wild-type and V599E mutant BRAF activity in vitro. In addition, BAY 43-9006 demonstrated significant activity against several receptor tyrosine kinases involved in neovascularization and tumor progression, including vascular endothelial growth factor receptor (VEGFR)-2, VEGFR-3, platelet-derived growth factor receptor ß, Flt-3, and c-KIT. In cellular mechanistic assays, BAY 43-9006 demonstrated inhibition of the mitogen-activated protein kinase pathway in colon, pancreatic, and breast tumor cell lines expressing mutant KRAS or wild-type or mutant BRAF, whereas non–small-cell lung cancer cell lines expressing mutant KRAS were insensitive to inhibition of the mitogen-activated protein kinase pathway by BAY 43-9006. Potent inhibition of VEGFR-2, platelet-derived growth factor receptor ß, and VEGFR-3 cellular receptor autophosphorylation was also observed for BAY 43-9006. Once daily oral dosing of BAY 43-9006 demonstrated broad-spectrum antitumor activity in colon, breast, and non–small-cell lung cancer xenograft models. Immunohistochemistry demonstrated a close association between inhibition of tumor growth and inhibition of the extracellular signal-regulated kinases (ERKs) 1/2 phosphorylation in two of three xenograft models examined, consistent with inhibition of the RAF/MEK/ERK pathway in some but not all models. Additional analyses of microvessel density and microvessel area in the same tumor sections using antimurine CD31 antibodies demonstrated significant inhibition of neovascularization in all three of the xenograft models. These data demonstrate that BAY 43-9006 is a novel dual action RAF kinase and VEGFR inhibitor that targets tumor cell proliferation and tumor angiogenesis.




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 The OncologistHome page
L. Dal Lago, V. D'Hondt, and A. Awada
Selected Combination Therapy with Sorafenib: A Review of Clinical Data and Perspectives in Advanced Solid Tumors
Oncologist, August 1, 2008; 13(8): 845 - 858.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
J. M. Llovet, S. Ricci, V. Mazzaferro, P. Hilgard, E. Gane, J.-F. Blanc, A. C. de Oliveira, A. Santoro, J.-L. Raoul, A. Forner, et al.
Sorafenib in Advanced Hepatocellular Carcinoma
N. Engl. J. Med., July 24, 2008; 359(4): 378 - 390.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
L. R. Roberts
Sorafenib in Liver Cancer -- Just the Beginning
N. Engl. J. Med., July 24, 2008; 359(4): 420 - 422.
[Full Text] [PDF]

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 J. Biol. Chem.Home page
R. Matsushima-Nishiwaki, S. Takai, S. Adachi, C. Minamitani, E. Yasuda, T. Noda, K. Kato, H. Toyoda, Y. Kaneoka, A. Yamaguchi, et al.
Phosphorylated Heat Shock Protein 27 Represses Growth of Hepatocellular Carcinoma via Inhibition of Extracellular Signal-regulated Kinase
J. Biol. Chem., July 4, 2008; 283(27): 18852 - 18860.
[Abstract] [Full Text] [PDF]

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 Arch DermatolHome page
J. Autier, B. Escudier, J. Wechsler, A. Spatz, and C. Robert
Prospective Study of the Cutaneous Adverse Effects of Sorafenib, a Novel Multikinase Inhibitor
Arch Dermatol, July 1, 2008; 144(7): 886 - 892.
[Abstract] [Full Text] [PDF]

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 Am. J. Roentgenol.Home page
A. Sabir, R. Schor-Bardach, C. J. Wilcox, S. Rahmanuddin, M. B. Atkins, J. B. Kruskal, S. Signoretti, V. D. Raptopoulos, and S. N. Goldberg
Perfusion MDCT Enables Early Detection of Therapeutic Response to Antiangiogenic Therapy
Am. J. Roentgenol., July 1, 2008; 191(1): 133 - 139.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
F. Hilberg, G. J. Roth, M. Krssak, S. Kautschitsch, W. Sommergruber, U. Tontsch-Grunt, P. Garin-Chesa, G. Bader, A. Zoephel, J. Quant, et al.
BIBF 1120: Triple Angiokinase Inhibitor with Sustained Receptor Blockade and Good Antitumor Efficacy
Cancer Res., June 15, 2008; 68(12): 4774 - 4782.
[Abstract] [Full Text] [PDF]

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 BloodHome page
M. M. Hipp, N. Hilf, S. Walter, D. Werth, K. M. Brauer, M. P. Radsak, T. Weinschenk, H. Singh-Jasuja, and P. Brossart
Sorafenib, but not sunitinib, affects function of dendritic cells and induction of primary immune responses
Blood, June 15, 2008; 111(12): 5610 - 5620.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. A. Tran, C. D. Smith, M. Kester, and G. P. Robertson
Combining Nanoliposomal Ceramide with Sorafenib Synergistically Inhibits Melanoma and Breast Cancer Cell Survival to Decrease Tumor Development
Clin. Cancer Res., June 1, 2008; 14(11): 3571 - 3581.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
R. Kinkade, P. Dasgupta, A. Carie, D. Pernazza, M. Carless, S. Pillai, N. Lawrence, S. M. Sebti, and S. Chellappan
A Small Molecule Disruptor of Rb/Raf-1 Interaction Inhibits Cell Proliferation, Angiogenesis, and Growth of Human Tumor Xenografts in Nude Mice
Cancer Res., May 15, 2008; 68(10): 3810 - 3818.
[Abstract] [Full Text] [PDF]

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 JCOHome page
D. F. McDermott, J. A. Sosman, R. Gonzalez, F. S. Hodi, G. P. Linette, J. Richards, J. W. Jakub, M. Beeram, S. Tarantolo, S. Agarwala, et al.
Double-Blind Randomized Phase II Study of the Combination of Sorafenib and Dacarbazine in Patients With Advanced Melanoma: A Report From the 11715 Study Group
J. Clin. Oncol., May 1, 2008; 26(13): 2178 - 2185.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. Eto, Y. Kamiryo, A. Takeuchi, M. Harano, K. Tatsugami, M. Harada, K. Kiyoshima, M. Hamaguchi, T. Teshima, M. Tsuneyoshi, et al.
Posttransplant Administration of Cyclophosphamide and Donor Lymphocyte Infusion Induces Potent Antitumor Immunity to Solid Tumor
Clin. Cancer Res., May 1, 2008; 14(9): 2833 - 2840.
[Abstract] [Full Text] [PDF]

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 JAMAHome page
A. X. Zhu and G. K. Abou-Alfa
Expanding the Treatment Options for Hepatocellular Carcinoma: Combining Transarterial Chemoembolization With Radiofrequency Ablation
JAMA, April 9, 2008; 299(14): 1716 - 1718.
[Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
G. Ambrosini, H. S. Cheema, S. Seelman, A. Teed, E. B. Sambol, S. Singer, and G. K. Schwartz
Sorafenib inhibits growth and mitogen-activated protein kinase signaling in malignant peripheral nerve sheath cells
Mol. Cancer Ther., April 1, 2008; 7(4): 890 - 896.
[Abstract] [Full Text] [PDF]

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 Physiol. GenomicsHome page
L. Moreno-Vinasco, M. Gomberg-Maitland, M. L. Maitland, A. A. Desai, P. A. Singleton, S. Sammani, L. Sam, Y. Liu, A. N. Husain, R. M. Lang, et al.
Genomic assessment of a multikinase inhibitor, sorafenib, in a rodent model of pulmonary hypertension
Physiol Genomics, April 1, 2008; 33(2): 278 - 291.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
Y. Ding, E. A. Boguslawski, B. D. Berghuis, J. J. Young, Z. Zhang, K. Hardy, K. Furge, E. Kort, A. E. Frankel, R. V. Hay, et al.
Mitogen-activated protein kinase kinase signaling promotes growth and vascularization of fibrosarcoma
Mol. Cancer Ther., March 1, 2008; 7(3): 648 - 658.
[Abstract] [Full Text] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
J. Tsai, J. T. Lee, W. Wang, J. Zhang, H. Cho, S. Mamo, R. Bremer, S. Gillette, J. Kong, N. K. Haass, et al.
From the Cover: Discovery of a selective inhibitor of oncogenic B-Raf kinase with potent antimelanoma activity
PNAS, February 26, 2008; 105(8): 3041 - 3046.
[Abstract] [Full Text] [PDF]

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 JNCI J Natl Cancer InstHome page
W. Zhang, M. Konopleva, Y.-x. Shi, T. McQueen, D. Harris, X. Ling, Z. Estrov, A. Quintas-Cardama, D. Small, J. Cortes, et al.
Mutant FLT3: A Direct Target of Sorafenib in Acute Myelogenous Leukemia
J Natl Cancer Inst, February 6, 2008; 100(3): 184 - 198.
[Abstract] [Full Text] [PDF]

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 Am J Health Syst PharmHome page
J. J. Hiles and J. M. Kolesar
Role of sunitinib and sorafenib in the treatment of metastatic renal cell carcinoma
Am. J. Health Syst. Pharm., January 15, 2008; 65(2): 123 - 131.
[Abstract] [Full Text] [PDF]

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 Annals of Clinical & Laboratory ScienceHome page
W. Feng, R. E. Brown, C. D. Trung, W. Li, L. Wang, T. Khoury, S. Alrawi, J. Yao, K. Xia, and D. Tan
Morphoproteomic Profile of mTOR, Ras/Raf Kinase/ERK, and NF-{kappa}B Pathways in Human Gastric Adenocarcinoma
Ann. Clin. Lab. Sci., January 1, 2008; 38(3): 195 - 209.
[Abstract] [Full Text] [PDF]

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 Toxicol PatholHome page
D. W. Hedley, S. Chow, C. Goolsby, and T. V. Shankey
Pharmacodynamic Monitoring of Molecular-Targeted Agents in the Peripheral Blood of Leukemia Patients Using Flow Cytometry
Toxicol Pathol, January 1, 2008; 36(1): 133 - 139.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. A. Blansfield, D. Caragacianu, H. R. Alexander III, M. A. Tangrea, S. Y. Morita, D. Lorang, P. Schafer, G. Muller, D. Stirling, R. E. Royal, et al.
Combining Agents that Target the Tumor Microenvironment Improves the Efficacy of Anticancer Therapy
Clin. Cancer Res., January 1, 2008; 14(1): 270 - 280.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
D. W. Ball, N. Jin, D. M. Rosen, A. Dackiw, D. Sidransky, M. Xing, and B. D. Nelkin
Selective Growth Inhibition in BRAF Mutant Thyroid Cancer by the Mitogen-Activated Protein Kinase Kinase 1/2 Inhibitor AZD6244
J. Clin. Endocrinol. Metab., December 1, 2007; 92(12): 4712 - 4718.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
L. J. Costa and H. A. Drabkin
Renal Cell Carcinoma: New Developments in Molecular Biology and Potential for Targeted Therapies
Oncologist, December 1, 2007; 12(12): 1404 - 1415.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. J. Ratain and R. H. Glassman
Biomarkers in Phase I Oncology Trials: Signal, Noise, or Expensive Distraction?
Clin. Cancer Res., November 15, 2007; 13(22): 6545 - 6548.
[Full Text] [PDF]

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 Jpn J Clin OncolHome page
H. Akaza, T. Tsukamoto, M. Murai, K. Nakajima, and S. Naito
Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Sorafenib in Japanese Patients with Advanced Renal Cell Carcinoma
Jpn. J. Clin. Oncol., October 19, 2007; (2007) hym095v1.
[Abstract] [Full Text] [PDF]

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 J. Biol. Chem.Home page
I. Plaza-Menacho, L. Mologni, E. Sala, C. Gambacorti-Passerini, A. I. Magee, T. P. Links, R. M. W. Hofstra, D. Barford, and C. M. Isacke
Sorafenib Functions to Potently Suppress RET Tyrosine Kinase Activity by Direct Enzymatic Inhibition and Promoting RET Lysosomal Degradation Independent of Proteasomal Targeting
J. Biol. Chem., October 5, 2007; 282(40): 29230 - 29240.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
L. Ying, A. B. Hofseth, D. D. Browning, M. Nagarkatti, P. S. Nagarkatti, and L. J. Hofseth
Nitric Oxide Inactivates the Retinoblastoma Pathway in Chronic Inflammation
Cancer Res., October 1, 2007; 67(19): 9286 - 9293.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
J. P. Plastaras, S.-H. Kim, Y. Y. Liu, D. T. Dicker, J. F. Dorsey, J. McDonough, G. Cerniglia, R. R. Rajendran, A. Gupta, A. K. Rustgi, et al.
Cell Cycle Dependent and Schedule-Dependent Antitumor Effects of Sorafenib Combined with Radiation
Cancer Res., October 1, 2007; 67(19): 9443 - 9454.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
B. Martinez-Poveda, R. Munoz-Chapuli, S. Rodriguez-Nieto, J. M. Quintela, A. Fernandez, M.-A. Medina, and A. R. Quesada
IB05204, a dichloropyridodithienotriazine, inhibits angiogenesis in vitro and in vivo
Mol. Cancer Ther., October 1, 2007; 6(10): 2675 - 2685.
[Abstract] [Full Text] [PDF]

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 J Biomol ScreenHome page
T. Ishii, H. Sootome, Y. Yagi, K. Yamashita, T. Noumi, and N. Noro
A Selective Cellular Screening Assay for B-Raf and c-Raf Kinases
J Biomol Screen, September 1, 2007; 12(6): 818 - 827.
[Abstract] [PDF]

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 Mol. Pharmacol.Home page
M. Rahmani, T. K. Nguyen, P. Dent, and S. Grant
The Multikinase Inhibitor Sorafenib Induces Apoptosis in Highly Imatinib Mesylate-Resistant Bcr/Abl+ Human Leukemia Cells in Association with Signal Transducer and Activator of Transcription 5 Inhibition and Myeloid Cell Leukemia-1 Down-Regulation
Mol. Pharmacol., September 1, 2007; 72(3): 788 - 795.
[Abstract] [Full Text] [PDF]

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 JCOHome page
C. Elser, L. L. Siu, E. Winquist, M. Agulnik, G. R. Pond, S. F. Chin, P. Francis, R. Cheiken, J. Elting, A. McNabola, et al.
Phase II Trial of Sorafenib in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Nasopharyngeal Carcinoma
J. Clin. Oncol., August 20, 2007; 25(24): 3766 - 3773.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
I. Duran, S. J. Hotte, H. Hirte, E. X. Chen, M. MacLean, S. Turner, L. Duan, G. R. Pond, C. Lathia, S. Walsh, et al.
Phase I Targeted Combination Trial of Sorafenib and Erlotinib in Patients with Advanced Solid Tumors
Clin. Cancer Res., August 15, 2007; 13(16): 4849 - 4857.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
T. Guo, N. P. Agaram, G. C. Wong, G. Hom, D. D'Adamo, R. G. Maki, G. K. Schwartz, D. Veach, B. D. Clarkson, S. Singer, et al.
Sorafenib Inhibits the Imatinib-Resistant KITT670I Gatekeeper Mutation in Gastrointestinal Stromal Tumor
Clin. Cancer Res., August 15, 2007; 13(16): 4874 - 4881.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. A. Gollob, W. K. Rathmell, T. M. Richmond, C. B. Marino, E. K. Miller, G. Grigson, C. Watkins, L. Gu, B. L. Peterson, and J. J. Wright
Phase II Trial of Sorafenib Plus Interferon Alfa-2b As First- or Second-Line Therapy in Patients With Metastatic Renal Cell Cancer
J. Clin. Oncol., August 1, 2007; 25(22): 3288 - 3295.
[Abstract] [Full Text] [PDF]


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