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[Cancer Research 62, 5749-5754, October 15, 2002]
© 2002 American Association for Cancer Research

Experimental Therapeutics

ZD1839 (Iressa)

An Orally Active Inhibitor of Epidermal Growth Factor Signaling with Potential for Cancer Therapy

Alan E. Wakeling1, Simon P. Guy, Jim R. Woodburn, Susan E. Ashton, Brenda J. Curry, Andrew J. Barker and Keith H. Gibson

Department of Cancer and Infection Research, AstraZeneca Pharmaceuticals, Alderley Park, Macclesfield, Cheshire SK10 4TG, United Kingdom

The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy because of its role in tumor growth, metastasis and angiogenesis, and tumor resistance to chemotherapy and radiotherapy. We have developed a low-molecular-weight EGFR tyrosine kinase inhibitor (EGFR-TKI), ZD1839 (Iressa2 ). ZD1839, a substituted anilinoquinazoline, is a potent EGFR-TKI (IC50 = 0.033 µM) that selectively inhibits EGF-stimulated tumor cell growth (IC50 = 0.054 µM) and that blocks EGF-stimulated EGFR autophosphorylation in tumor cells. In studies with mice bearing a range of human tumor-derived xenografts, ZD1839 given p.o. once a day inhibited tumor growth in a dose-dependent manner. The level of expression of EGFR did not determine xenograft tumor sensitivity to ZD1839. Long-term ZD1839 (>3 months) treatment of mice bearing A431 xenografts was well tolerated, and ZD1839 completely inhibited tumor growth and induced regression of established tumors. No drug-resistant tumors appeared during ZD1839 treatment, but some tumors regrew after drug withdrawal. These studies indicate the potential utility of ZD1839 in the treatment of many human tumors and indicate that continuous once-a-day p.o. dosing might be a suitable therapeutic regimen.




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S. Van Schaeybroeck, A. Karaiskou-McCaul, D. Kelly, D. Longley, L. Galligan, E. Van Cutsem, and P. Johnston
Epidermal Growth Factor Receptor Activity Determines Response of Colorectal Cancer Cells to Gefitinib Alone and in Combination with Chemotherapy
Clin. Cancer Res., October 15, 2005; 11(20): 7480 - 7489.
[Abstract] [Full Text] [PDF]

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 BloodHome page
K. Stegmaier, S. M. Corsello, K. N. Ross, J. S. Wong, D. J. DeAngelo, and T. R. Golub
Gefitinib induces myeloid differentiation of acute myeloid leukemia
Blood, October 15, 2005; 106(8): 2841 - 2848.
[Abstract] [Full Text] [PDF]

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 Eur J EndocrinolHome page
A. R Gunthert, C. Grundker, A. Olota, J. Lasche, N. Eicke, and G. Emons
Analogs of GnRH-I and GnRH-II inhibit epidermal growth factor-induced signal transduction and resensitize resistant human breast cancer cells to 4OH-tamoxifen
Eur. J. Endocrinol., October 1, 2005; 153(4): 613 - 625.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
F. M. Johnson, B. Saigal, M. Talpaz, and N. J. Donato
Dasatinib (BMS-354825) Tyrosine Kinase Inhibitor Suppresses Invasion and Induces Cell Cycle Arrest and Apoptosis of Head and Neck Squamous Cell Carcinoma and Non-Small Cell Lung Cancer Cells
Clin. Cancer Res., October 1, 2005; 11(19): 6924 - 6932.
[Abstract] [Full Text] [PDF]

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 JCOHome page
N. C. Daw, W. L. Furman, C. F. Stewart, L. C. Iacono, M. Krailo, M. L. Bernstein, J. E. Dancey, R. A. Speights, S. M. Blaney, J. M. Croop, et al.
Phase I and Pharmacokinetic Study of Gefitinib in Children With Refractory Solid Tumors: A Children's Oncology Group Study
J. Clin. Oncol., September 1, 2005; 23(25): 6172 - 6180.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
B. Solomon, D. Binns, P. Roselt, L. I. Weibe, G. A. McArthur, C. Cullinane, and R. J. Hicks
Modulation of intratumoral hypoxia by the epidermal growth factor receptor inhibitor gefitinib detected using small animal PET imaging
Mol. Cancer Ther., September 1, 2005; 4(9): 1417 - 1422.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
W. S. Siegel-Lakhai, J. H. Beijnen, and J. H.M. Schellens
Current Knowledge and Future Directions of the Selective Epidermal Growth Factor Receptor Inhibitors Erlotinib (Tarceva(R)) and Gefitinib (Iressa(R))
Oncologist, September 1, 2005; 10(8): 579 - 589.
[Abstract] [Full Text] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
A. Jain, C. A. Tindell, I. Laux, J. B. Hunter, J. Curran, A. Galkin, D. E. Afar, N. Aronson, S. Shak, R. B. Natale, et al.
Epithelial membrane protein-1 is a biomarker of gefitinib resistance
PNAS, August 16, 2005; 102(33): 11858 - 11863.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. Taron, Y. Ichinose, R. Rosell, T. Mok, B. Massuti, L. Zamora, J. L. Mate, C. Manegold, M. Ono, C. Queralt, et al.
Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor Are Associated with Improved Survival in Gefitinib-Treated Chemorefractory Lung Adenocarcinomas
Clin. Cancer Res., August 15, 2005; 11(16): 5878 - 5885.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. Baselga, J. Albanell, A. Ruiz, A. Lluch, P. Gascon, V. Guillem, S. Gonzalez, S. Sauleda, I. Marimon, J. M. Tabernero, et al.
Phase II and Tumor Pharmacodynamic Study of Gefitinib in Patients with Advanced Breast Cancer
J. Clin. Oncol., August 10, 2005; 23(23): 5323 - 5333.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
C.-H. Yang, C.-J. Huang, C.-S. Yang, Y.-C. Chu, A.-L. Cheng, J. Whang-Peng, and P.-C. Yang
Gefitinib Reverses Chemotherapy Resistance in Gefitinib-Insensitive Multidrug Resistant Cancer Cells Expressing ATP-Binding Cassette Family Protein
Cancer Res., August 1, 2005; 65(15): 6943 - 6949.
[Abstract] [Full Text] [PDF]

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R. J. Schilder, M. W. Sill, X. Chen, K. M. Darcy, S. L. Decesare, G. Lewandowski, R. B. Lee, C. A. Arciero, H. Wu, and A. K. Godwin
Phase II Study of Gefitinib in Patients with Relapsed or Persistent Ovarian or Primary Peritoneal Carcinoma and Evaluation of Epidermal Growth Factor Receptor Mutations and Immunohistochemical Expression: A Gynecologic Oncology Group Study
Clin. Cancer Res., August 1, 2005; 11(15): 5539 - 5548.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
K. Kiguchi, L. Ruffino, T. Kawamoto, T. Ajiki, and J. DiGiovanni
Chemopreventive and Therapeutic Efficacy of Orally Active Tyrosine Kinase Inhibitors in a Transgenic Mouse Model of Gallbladder Carcinoma
Clin. Cancer Res., August 1, 2005; 11(15): 5572 - 5580.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
A Agrawal, E Gutteridge, J M W Gee, R I Nicholson, and J F R Robertson
Overview of tyrosine kinase inhibitors in clinical breast cancer
Endocr. Relat. Cancer, July 1, 2005; 12(Supplement_1): S135 - S144.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
H E Jones, J M W Gee, K M Taylor, D Barrow, H D Williams, M Rubini, and R I Nicholson
Development of strategies for the use of anti-growth factor treatments
Endocr. Relat. Cancer, July 1, 2005; 12(Supplement_1): S173 - S182.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
A E Wakeling
Inhibitors of growth factor signalling
Endocr. Relat. Cancer, July 1, 2005; 12(Supplement_1): S183 - S187.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
X. L. Mu, L. Y. Li, X. T. Zhang, M. Z. Wang, R. E. Feng, Q. C. Cui, H. S. Zhou, and B. Q. Guo
Gefitinib-Sensitive Mutations of the Epidermal Growth Factor Receptor Tyrosine Kinase Domain in Chinese Patients with Non-Small Cell Lung Cancer
Clin. Cancer Res., June 15, 2005; 11(12): 4289 - 4294.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
P. Sini, L. Wyder, C. Schnell, T. O'Reilly, A. Littlewood, R. Brandt, N. E. Hynes, and J. Wood
The Antitumor and Antiangiogenic Activity of Vascular Endothelial Growth Factor Receptor Inhibition Is Potentiated by ErbB1 Blockade
Clin. Cancer Res., June 15, 2005; 11(12): 4521 - 4532.
[Abstract] [Full Text] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
E. L. Kwak, R. Sordella, D. W. Bell, N. Godin-Heymann, R. A. Okimoto, B. W. Brannigan, P. L. Harris, D. R. Driscoll, P. Fidias, T. J. Lynch, et al.
Irreversible inhibitors of the EGF receptor may circumvent acquired resistance to gefitinib
PNAS, May 24, 2005; 102(21): 7665 - 7670.
[Abstract] [Full Text] [PDF]

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 JCOHome page
E. F. Petricoin III, V. E. Bichsel, V. S. Calvert, V. Espina, M. Winters, L. Young, C. Belluco, B. J. Trock, M. Lippman, D. A. Fishman, et al.
Mapping Molecular Networks Using Proteomics: A Vision for Patient-Tailored Combination Therapy
J. Clin. Oncol., May 20, 2005; 23(15): 3614 - 3621.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
A. Yoshimoto, K. Kasahara, M. Nishio, T. Hourai, T. Sone, H. Kimura, M. Fujimura, and S. Nakao
Changes in Angiogenic Growth Factor Levels After Gefitinib Treatment in Non-small Cell Lung Cancer
Jpn. J. Clin. Oncol., May 1, 2005; 35(5): 233 - 238.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
Y. Liu, S. Majumder, W. McCall, C. I. Sartor, J. L. Mohler, C. W. Gregory, H. S. Earp, and Y. E. Whang
Inhibition of HER-2/neu Kinase Impairs Androgen Receptor Recruitment to the Androgen Responsive Enhancer
Cancer Res., April 15, 2005; 65(8): 3404 - 3409.
[Abstract] [Full Text] [PDF]

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J. W. Lee, Y. H. Soung, S. Y. Kim, H. K. Nam, W. S. Park, S. W. Nam, M. S. Kim, D. I. Sun, Y. S. Lee, J. J. Jang, et al.
Somatic Mutations of EGFR Gene in Squamous Cell Carcinoma of the Head and Neck
Clin. Cancer Res., April 15, 2005; 11(8): 2879 - 2882.
[Abstract] [Full Text] [PDF]

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 JCOHome page
W. Pao and V. A. Miller
Epidermal Growth Factor Receptor Mutations, Small-Molecule Kinase Inhibitors, and Non-Small-Cell Lung Cancer: Current Knowledge and Future Directions
J. Clin. Oncol., April 10, 2005; 23(11): 2556 - 2568.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
D. McKillop, E. A. Partridge, J. V. Kemp, M. P. Spence, J. Kendrew, S. Barnett, P. G. Wood, P. B. Giles, A. B. Patterson, F. Bichat, et al.
Tumor penetration of gefitinib (Iressa), an epidermal growth factor receptor tyrosine kinase inhibitor
Mol. Cancer Ther., April 1, 2005; 4(4): 641 - 649.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
G. Giaccone
HER1/EGFR-targeted agents: predicting the future for patients with unpredictable outcomes to therapy
Ann. Onc., April 1, 2005; 16(4): 538 - 548.
[Abstract] [Full Text] [PDF]

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S. H. Yang, L. E. Mechanic, P. Yang, M. T. Landi, E. D. Bowman, J. Wampfler, D. Meerzaman, K. M. Hong, F. Mann, T. Dracheva, et al.
Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor in Non-Small Cell Lung Cancer
Clin. Cancer Res., March 15, 2005; 11(6): 2106 - 2110.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
K.-S. Kim, J.-Y. Jeong, Y.-C. Kim, K.-J. Na, Y.-H. Kim, S.-J. Ahn, S.-M. Baek, C.-S. Park, C.-M. Park, Y.-I. Kim, et al.
Predictors of the Response to Gefitinib in Refractory Non-Small Cell Lung Cancer
Clin. Cancer Res., March 15, 2005; 11(6): 2244 - 2251.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. J. Mantha, J. E.L. Hanson, G. Goss, A. E. Lagarde, I. A. Lorimer, and J. Dimitroulakos
Targeting the Mevalonate Pathway Inhibits the Function of the Epidermal Growth Factor Receptor
Clin. Cancer Res., March 15, 2005; 11(6): 2398 - 2407.
[Abstract] [Full Text] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
J. A. Engelman, P. A. Janne, C. Mermel, J. Pearlberg, T. Mukohara, C. Fleet, K. Cichowski, B. E. Johnson, and L. C. Cantley
ErbB-3 mediates phosphoinositide 3-kinase activity in gefitinib-sensitive non-small cell lung cancer cell lines
PNAS, March 8, 2005; 102(10): 3788 - 3793.
[Abstract] [Full Text] [PDF]

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 JNCI J Natl Cancer InstHome page
H. Shigematsu, L. Lin, T. Takahashi, M. Nomura, M. Suzuki, I. I. Wistuba, K. M. Fong, H. Lee, S. Toyooka, N. Shimizu, et al.
Clinical and Biological Features Associated With Epidermal Growth Factor Receptor Gene Mutations in Lung Cancers
J Natl Cancer Inst, March 2, 2005; 97(5): 339 - 346.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
C. W. Gregory, Y. E. Whang, W. McCall, X. Fei, Y. Liu, L. A. Ponguta, F. S. French, E. M. Wilson, and H. S. Earp III
Heregulin-Induced Activation of HER2 and HER3 Increases Androgen Receptor Transactivation and CWR-R1 Human Recurrent Prostate Cancer Cell Growth
Clin. Cancer Res., March 1, 2005; 11(5): 1704 - 1712.
[Abstract] [Full Text] [PDF]

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 Cold Spring Harb Symp Quant BiolHome page
R.K. THOMAS, H. GREULICH, Y. YUZA, J.C. LEE, T. TENGS, W. FENG, T.-H. CHEN, E. NICKERSON, J. SIMONS, M. EGHOLM, et al.
Detection of Oncogenic Mutations in the EGFR Gene in Lung Adenocarcinoma with Differential Sensitivity to EGFR Tyrosine Kinase Inhibitors
Cold Spring Harb Symp Quant Biol, January 1, 2005; 70(0): 73 - 81.
[Abstract] [PDF]

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 Cold Spring Harb Symp Quant BiolHome page
D.A. HABER, D.W. BELL, R. SORDELLA, E.L. KWAK, N. GODIN-HEYMANN, S.V. SHARMA, T.J. LYNCH, and J. SETTLEMAN
Molecular Targeted Therapy of Lung Cancer: EGFR Mutations and Response to EGFR Inhibitors
Cold Spring Harb Symp Quant Biol, January 1, 2005; 70(0): 419 - 426.
[Abstract] [PDF]

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N. T. Shah, M. G. Kris, W. Pao, L. B. Tyson, B. M. Pizzo, M.-H. Heinemann, L. Ben-Porat, D. L. Sachs, R. T. Heelan, and V. A. Miller
Practical Management of Patients With Non-Small-Cell Lung Cancer Treated With Gefitinib
J. Clin. Oncol., January 1, 2005; 23(1): 165 - 174.
[Abstract] [Full Text] [PDF]

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T. De Pas, G. Pelosi, F. de Braud, G. Veronesi, G. Curigliano, M. E. Leon, R. Danesi, C. Noberasco, M. d'Aiuto, G. Catalano, et al.
Modulation of Epidermal Growth Factor Receptor Status by Chemotherapy in Patients With Locally Advanced Non-Small-Cell Lung Cancer Is Rare
J. Clin. Oncol., December 15, 2004; 22(24): 4966 - 4970.
[Abstract] [Full Text] [PDF]

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 Hum Mol GenetHome page
S. Kakiuchi, Y. Daigo, N. Ishikawa, C. Furukawa, T. Tsunoda, S. Yano, K. Nakagawa, T. Tsuruo, N. Kohno, M. Fukuoka, et al.
Prediction of sensitivity of advanced non-small cell lung cancers to gefitinib (Iressa, ZD1839)
Hum. Mol. Genet., December 15, 2004; 13(24): 3029 - 3043.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
K. J. Williams, B. A. Telfer, S. Brave, J. Kendrew, L. Whittaker, I. J. Stratford, and S. R. Wedge
ZD6474, a Potent Inhibitor of Vascular Endothelial Growth Factor Signaling, Combined With Radiotherapy: Schedule-Dependent Enhancement of Antitumor Activity
Clin. Cancer Res., December 15, 2004; 10(24): 8587 - 8593.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
B. Nicholson, K. Gulding, M. Conaway, S. R. Wedge, and D. Theodorescu
Combination Antiangiogenic and Androgen Deprivation Therapy for Prostate Cancer: A Promising Therapeutic Approach
Clin. Cancer Res., December 15, 2004; 10(24): 8728 - 8734.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
H E Jones, L Goddard, J M W Gee, S Hiscox, M Rubini, D Barrow, J M Knowlden, S Williams, A E Wakeling, and R I Nicholson
Insulin-like growth factor-I receptor signalling and acquired resistance to gefitinib (ZD1839; Iressa) in human breast and prostate cancer cells
Endocr. Relat. Cancer, December 1, 2004; 11(4): 793 - 814.
[Abstract] [Full Text] [PDF]


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