Title:
THERAPEUTIC AGENT FOR LUNG CANCER THAT HAS ACQUIRED EGFR-TKI RESISTANCE
Document Type and Number:
WIPO Patent Application WO/2017/200016
Kind Code:
A1
Abstract:
A drug having as the active ingredients brigatinib, an AP26113 analog, and a compound represented by AZD3463, which are ALK inhibitors, was discovered to be effective in non-small cell lung cancer having a point mutation in EGFR C797S that has acquired resistance to chemotherapeutics. Furthermore, a remarkable suppressive effect on tumor growth is demonstrated by using an anti-EGFR antibody in combination. This agent serves as a therapeutic agent that is effective in non-small cell lung cancer having resistance to gefitinib, which is a first generation therapeutic agent, and osimertinib, which is a third generation therapeutic agent.
Inventors:
KATAYAMA RYOHEI (JP)
UCHIBORI KEN (JP)
FUJITA NAOYA (JP)
UCHIBORI KEN (JP)
FUJITA NAOYA (JP)
Application Number:
PCT/JP2017/018573
Publication Date:
November 23, 2017
Filing Date:
May 17, 2017
Export Citation:
Assignee:
JAPANESE FOUND FOR CANCER RES (JP)
International Classes:
A61K31/506; A61K31/662; A61P11/00; A61P35/00; C12Q1/68; G01N33/574
Domestic Patent References:
| WO2015097621A2 | 2015-07-02 |
Foreign References:
| JP2013539795A | 2013-10-28 | |||
| JP2014177456A | 2014-09-25 |
Other References:
MIRET J J ET AL.: "MO11.12 AP26113, A POTENT ALK INHIBITOR, IS ALSO ACTIVE AGAINST EGFR T790M", JOURNAL OF THORACIC ONCOLOGY, vol. 6, no. 6, 5 July 2011 (2011-07-05), pages S577 - S578, XP055598288
RIVERA, V M ET AL.: "AP 26113 is dual ALK/EGFR inhibitor: Characterization against EGFR T790M in cell and mouse models of NSCLC", CANCER RES, vol. 72, no. 8, March 2012 (2012-03-01), XP055598373
CAMIDGE, D R ET AL.: "8031: First-in-human dose-finding study of the ALK/EGFR inhibitor AP 26113 in patients with advanced malignancies: Updated results", JOURNAL OF CLINICAL ONCOLOGY, vol. 31, no. 15, 2013, XP055598282
DREW, L ET AL.: "Abstract 4465: Concurrent roles for IGF1R and EGFR in driving acquired resistance to crizotinib and ability to overcome with a combination of the ALK/IGF1R inhibitor AZD3463 and Iressa", CANCER RES AACR 104TH ANNUAL MEETING, vol. 73, no. 8 Supp, April 2013 (2013-04-01), XP055598284
THRESS, K S ET AL.: "Acquired EGFR C795S mediates resistance to AZD9291 in advanced non-small cell lung cancer harboring EGFR T790M", NAT MED, vol. 21, no. 6, June 2015 (2015-06-01), pages 560 - 562, XP055598374
UCHIBORI, K ET AL.: "Brigatinib combined with anti-EGFR antibody overcomes osimertinib resistance in EGFR-muteted non-small- cell lung cancer", NAT COMMUN, vol. 8, no. 1, 13 March 2017 (2017-03-13), pages 1 - 16, XP055598376
OHNO YUKO; NAKAMURA TAKASHI ET AL.: "Prediction of cancer incidence in Japan - Projections up to 2020 based on the analyses using a Bayesian Poisson cohort model: Cancer Statistics - incidence/death/prognosis - 2004", 2004, SHINOHARA SHUPPAN
SHILLER, J. H. ET AL., N. ENGL. J. MED., vol. 346, 2002, pages 92 - 98
OHE Y. ET AL., ANN. ONCOL., vol. 8, 2007, pages 317 - 323
PAZ-ARES L.G. ET AL., J. CLIN. ONCOL., vol. 31, 2013, pages 2895 - 2902
SANDLER, A. ET AL., N. ENGL. J. MED., vol. 355, 2006, pages 2542 - 2550
PAEZ, J.G. ET AL., SCIENCE, vol. 304, 2004, pages 1497 - 1500
LYNCH, T. J. ET AL., N. ENGL. J. MED., vol. 350, 2004, pages 2129 - 2139
MITSUDOMI T. ET AL., THE FEBS J., vol. 277, 2010, pages 301 - 308
MOK, T. S. ET AL., N. ENGL. J. MED., vol. 361, 2009, pages 947 - 957
MAEMONDO, M. ET AL., N. ENGL. J. MED., vol. 362, 2010, pages 2380 - 2388
MITSUDOMI, T. ET AL., LANCET ONCOL., vol. 11, 2010, pages 121 - 128
KRIS M.G. ET AL., JAMA, vol. 311, 2014, pages 1998 - 2006
YU, H.A. ET AL., CLIN. CANCER RES., vol. 19, 2013, pages 2240 - 2247
JANJIGIAN, Y.Y. ET AL., CANCER DISCOV., vol. 4, 2014, pages 1036 - 45
CROSS, D.A. ET AL., CANCER DISCOV., vol. 4, 2014, pages 1046 - 1061
JANNE, P.A. ET AL., N. ENGL. J. MED., vol. 372, 2015, pages 1689 - 1699
THRESS, K.S. ET AL., NAT. MED., vol. 21, no. 6, 2015, pages 560 - 562
EBERLEIN, C.A. ET AL., CANCER RES., vol. 75, 2015, pages 2489 - 2500
ERCAN D. ET AL., CLIN. CANCER RES., vol. 21, 2015, pages 3913 - 23
NIEDERST, M.J. ET AL., CLIN. CANCER RES., vol. 21, 2015, pages 3924 - 3933
JIA, Y. ET AL., NATURE, vol. 534, 2016, pages 129 - 132
LI, S. ET AL., CANCER CELL, vol. 7, 2005, pages 301 - 311
SICKMIER, E. A. ET AL., PLOS ONE, 2016
BROWER, M.E. ET AL., FDA PHARMACOLOGY REVIEW(S, 2015
See also references of EP 3453392A4
RIVERA, V M ET AL.: "AP 26113 is dual ALK/EGFR inhibitor: Characterization against EGFR T790M in cell and mouse models of NSCLC", CANCER RES, vol. 72, no. 8, March 2012 (2012-03-01), XP055598373
CAMIDGE, D R ET AL.: "8031: First-in-human dose-finding study of the ALK/EGFR inhibitor AP 26113 in patients with advanced malignancies: Updated results", JOURNAL OF CLINICAL ONCOLOGY, vol. 31, no. 15, 2013, XP055598282
DREW, L ET AL.: "Abstract 4465: Concurrent roles for IGF1R and EGFR in driving acquired resistance to crizotinib and ability to overcome with a combination of the ALK/IGF1R inhibitor AZD3463 and Iressa", CANCER RES AACR 104TH ANNUAL MEETING, vol. 73, no. 8 Supp, April 2013 (2013-04-01), XP055598284
THRESS, K S ET AL.: "Acquired EGFR C795S mediates resistance to AZD9291 in advanced non-small cell lung cancer harboring EGFR T790M", NAT MED, vol. 21, no. 6, June 2015 (2015-06-01), pages 560 - 562, XP055598374
UCHIBORI, K ET AL.: "Brigatinib combined with anti-EGFR antibody overcomes osimertinib resistance in EGFR-muteted non-small- cell lung cancer", NAT COMMUN, vol. 8, no. 1, 13 March 2017 (2017-03-13), pages 1 - 16, XP055598376
OHNO YUKO; NAKAMURA TAKASHI ET AL.: "Prediction of cancer incidence in Japan - Projections up to 2020 based on the analyses using a Bayesian Poisson cohort model: Cancer Statistics - incidence/death/prognosis - 2004", 2004, SHINOHARA SHUPPAN
SHILLER, J. H. ET AL., N. ENGL. J. MED., vol. 346, 2002, pages 92 - 98
OHE Y. ET AL., ANN. ONCOL., vol. 8, 2007, pages 317 - 323
PAZ-ARES L.G. ET AL., J. CLIN. ONCOL., vol. 31, 2013, pages 2895 - 2902
SANDLER, A. ET AL., N. ENGL. J. MED., vol. 355, 2006, pages 2542 - 2550
PAEZ, J.G. ET AL., SCIENCE, vol. 304, 2004, pages 1497 - 1500
LYNCH, T. J. ET AL., N. ENGL. J. MED., vol. 350, 2004, pages 2129 - 2139
MITSUDOMI T. ET AL., THE FEBS J., vol. 277, 2010, pages 301 - 308
MOK, T. S. ET AL., N. ENGL. J. MED., vol. 361, 2009, pages 947 - 957
MAEMONDO, M. ET AL., N. ENGL. J. MED., vol. 362, 2010, pages 2380 - 2388
MITSUDOMI, T. ET AL., LANCET ONCOL., vol. 11, 2010, pages 121 - 128
KRIS M.G. ET AL., JAMA, vol. 311, 2014, pages 1998 - 2006
YU, H.A. ET AL., CLIN. CANCER RES., vol. 19, 2013, pages 2240 - 2247
JANJIGIAN, Y.Y. ET AL., CANCER DISCOV., vol. 4, 2014, pages 1036 - 45
CROSS, D.A. ET AL., CANCER DISCOV., vol. 4, 2014, pages 1046 - 1061
JANNE, P.A. ET AL., N. ENGL. J. MED., vol. 372, 2015, pages 1689 - 1699
THRESS, K.S. ET AL., NAT. MED., vol. 21, no. 6, 2015, pages 560 - 562
EBERLEIN, C.A. ET AL., CANCER RES., vol. 75, 2015, pages 2489 - 2500
ERCAN D. ET AL., CLIN. CANCER RES., vol. 21, 2015, pages 3913 - 23
NIEDERST, M.J. ET AL., CLIN. CANCER RES., vol. 21, 2015, pages 3924 - 3933
JIA, Y. ET AL., NATURE, vol. 534, 2016, pages 129 - 132
LI, S. ET AL., CANCER CELL, vol. 7, 2005, pages 301 - 311
SICKMIER, E. A. ET AL., PLOS ONE, 2016
BROWER, M.E. ET AL., FDA PHARMACOLOGY REVIEW(S, 2015
See also references of EP 3453392A4
Attorney, Agent or Firm:
SHIRAKATA Yumiko (JP)
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