Title:
PHARMACEUTICAL COMPOSITION FOR TREATING TUMOR
Document Type and Number:
WIPO Patent Application WO/2021/020336
Kind Code:
A1
Abstract:
In the present invention, the combined administration of a liposome composition containing eribulin or a pharmaceutically acceptable salt thereof and a PD-1 antagonist exhibits an unexpected anti-tumor effect.
Inventors:
SEMBA TARO (JP)
FUNAHASHI YASUHIRO (JP)
SUZUKI TAKUYA (JP)
FUNAHASHI YASUHIRO (JP)
SUZUKI TAKUYA (JP)
Application Number:
PCT/JP2020/028663
Publication Date:
February 04, 2021
Filing Date:
July 27, 2020
Export Citation:
Assignee:
EISAI R&D MAN CO LTD (JP)
ONO PHARMACEUTICAL CO (JP)
ONO PHARMACEUTICAL CO (JP)
International Classes:
A61K39/395; A61K9/127; A61K31/357; A61K45/00; A61P35/00
Domestic Patent References:
| WO2018071792A1 | 2018-04-19 | |||
| WO2017188350A1 | 2017-11-02 | |||
| WO2010113984A1 | 2010-10-07 | |||
| WO2010113983A1 | 2010-10-07 | |||
| WO1999065894A1 | 1999-12-23 | |||
| WO2005118565A1 | 2005-12-15 | |||
| WO2011094339A1 | 2011-08-04 | |||
| WO2010113984A1 | 2010-10-07 | |||
| WO2017188350A1 | 2017-11-02 | |||
| WO2016141209A1 | 2016-09-09 | |||
| WO2004004771A1 | 2004-01-15 | |||
| WO2004072286A1 | 2004-08-26 | |||
| WO2004056875A1 | 2004-07-08 |
Foreign References:
| JP2018508516A | 2018-03-29 | |||
| US6469182B1 | 2002-10-22 | |||
| US20060104984A1 | 2006-05-18 | |||
| US6653341B1 | 2003-11-25 | |||
| US6214865B1 | 2001-04-10 | |||
| US7488802B2 | 2009-02-10 | |||
| US7521051B2 | 2009-04-21 | |||
| US8008449B2 | 2011-08-30 | |||
| US8354509B2 | 2013-01-15 | |||
| US8168757B2 | 2012-05-01 | |||
| US20110271358A1 | 2011-11-03 |
Other References:
SM TOLANEY, K KALINSKY, V KAKLAMANI, C SAVULSKY, M OLIVO, G AKTAN, PA KAUFMAN, D XING, A ALMONTE, S MISIR, V KARANTZA, S DIAB: "ABSTRACT PD6-13 :Phase lb/2 study to evaluate eribulin mesylate in combination with pembrolizumab in patients with metastatic triple- negative breast cancer", CANCER RESEARCH, vol. 78, no. 4, 5 December 2017 (2017-12-05), XP055749240, ISSN: 1538-7445
ANONYMOUS: "History of Changes for Study: NCT04078295 A Study of E7389 liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor", 2 September 2019 (2019-09-02), pages 1 - 5, XP055879022, Retrieved from the Internet
NATURE IMMUNOLOGY, vol. 8, 2007, pages 239 - 245
DONG H ET AL.: "Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion", NAT MED., vol. 8, no. 8, August 2002 (2002-08-01), pages 793 - 800, XP002397368, DOI: 10.1038/nm730
YANG ET AL.: "PD-1 interaction contributes to the functional suppression of T-cell responses to human uveal melanoma cells in vitro", INVEST OPHTHALMOL VIS SCI., vol. 49, no. 6, June 2008 (2008-06-01), pages 2518 - 2525, XP055412241, DOI: 10.1167/iovs.07-1606
GHEBEH ET AL.: "The B7-H1 (PD-L1) T lymphocyte-inhibitory molecule is expressed in breast cancer patients with infiltrating ductal carcinoma: correlation with important high-risk prognostic factors", NEOPLASIA, vol. 8, 2006, pages 190 - 198, XP008091677, DOI: 10.1593/neo.05733
HAMANISHI J ET AL.: "Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer", PROCEEDING OF THE NATIONAL ACADEMY OF SCIENCES, vol. 104, 2007, pages 3360 - 3365
THOMPSON RH ET AL.: "Significance of B7-H1 overexpression in kidney cancer", CLINICAL GENITOURIN CANCER, vol. 5, 2006, pages 206 - 211, XP009114210, DOI: 10.3816/CGC.2006.n.038
NOMI, T.SHO, M.AKAHORI, T. ET AL.: "Clinical significance and therapeutic potential of the programmed death- 1 ligand/programmed death-1 pathway in human pancreatic cancer", CLINICAL CANCER RESEARCH, vol. 13, 2007, pages 2151 - 2157, XP002533527, DOI: 10.1158/1078-0432.CCR-06-2746
OHIGASHI Y ET AL.: "Clinical significance of programmed death-1 ligand-1 and programmed death-1 ligand 2 expression in human esophageal cancer", CLIN. CANCER RESEARCH, vol. 11, 2005, pages 2947 - 2953, XP002419631, DOI: 10.1158/1078-0432.CCR-04-1469
INMAN ET AL.: "PD-L1 (B7-H1) expression by urothelial carcinoma of the bladder and BCG-induced granulomata: associations with localized stage progression", CANCER, vol. 109, 2007, pages 1499 - 1505
SHIMAUCHI T ET AL.: "Augmented expression of programmed death-1 in both neoplasmatic and nonneoplastic CD4+ T-cells in adult T-cell Leukemia/Lymphoma", INT. J. CANCER, vol. 121, 2007, pages 2585 - 2590
GAO ET AL.: "Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma", CLINICAL CANCER RESEARCH, vol. 15, 2009, pages 971 - 979
NAKANISHI J.: "Overexpression ofB7-Hl (PD-Ll) significantly associates with tumor grade and postoperative prognosis in human urothelial cancers", CANCER IMMUNOL IMMUNOTHER., vol. 56, 2007, pages 1173 - 1182, XP019514169, DOI: 10.1007/s00262-006-0266-z
HINO ET AL.: "Tumor cell expression of programmed cell death-1 is a prognostic factor for malignant melanoma", CANCER, vol. 116, 2010, pages 1757 - 1766, XP009160407, DOI: 10.1002/cncr.24899
GHEBEH H: "Foxp3+ tregs and B7-H1+/PD-1+ T lymphocytes co-infiltrate the tumor tissues of high-risk breast cancer patients: implication for immunotherapy", BMC CANCER, vol. 23, no. 8, February 2008 (2008-02-01), pages 57
AHMADZADEH M. ET AL.: "Tumor antigen-specific CD8 T cells infiltrating the tumor express high levels of PD-1 and are functionally impaired", BLOOD, vol. 114, 2009, pages 1537 - 1544, XP055648069
THOMPSON RH ET AL.: "PD-1 is expressed by tumor infiltrating cells and is associated with poor outcome for patients with renal carcinoma", CLINICAL CANCER RESEARCH, vol. 15, 2007, pages 1757 - 1761, XP055613062, DOI: 10.1158/1078-0432.CCR-06-2599
HIROSHI KIKUCHI ET AL.: "Liposome I -How to prepare and assay", CELL TECHNOLOGY, vol. 2, no. 9, 1983, pages 1136 - 1149
United States Pharmacopoeia (USP; "NCBI", Database accession no. NP 079515
See also references of EP 3970745A4
ANONYMOUS: "History of Changes for Study: NCT04078295 A Study of E7389 liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor", 2 September 2019 (2019-09-02), pages 1 - 5, XP055879022, Retrieved from the Internet
NATURE IMMUNOLOGY, vol. 8, 2007, pages 239 - 245
DONG H ET AL.: "Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion", NAT MED., vol. 8, no. 8, August 2002 (2002-08-01), pages 793 - 800, XP002397368, DOI: 10.1038/nm730
YANG ET AL.: "PD-1 interaction contributes to the functional suppression of T-cell responses to human uveal melanoma cells in vitro", INVEST OPHTHALMOL VIS SCI., vol. 49, no. 6, June 2008 (2008-06-01), pages 2518 - 2525, XP055412241, DOI: 10.1167/iovs.07-1606
GHEBEH ET AL.: "The B7-H1 (PD-L1) T lymphocyte-inhibitory molecule is expressed in breast cancer patients with infiltrating ductal carcinoma: correlation with important high-risk prognostic factors", NEOPLASIA, vol. 8, 2006, pages 190 - 198, XP008091677, DOI: 10.1593/neo.05733
HAMANISHI J ET AL.: "Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer", PROCEEDING OF THE NATIONAL ACADEMY OF SCIENCES, vol. 104, 2007, pages 3360 - 3365
THOMPSON RH ET AL.: "Significance of B7-H1 overexpression in kidney cancer", CLINICAL GENITOURIN CANCER, vol. 5, 2006, pages 206 - 211, XP009114210, DOI: 10.3816/CGC.2006.n.038
NOMI, T.SHO, M.AKAHORI, T. ET AL.: "Clinical significance and therapeutic potential of the programmed death- 1 ligand/programmed death-1 pathway in human pancreatic cancer", CLINICAL CANCER RESEARCH, vol. 13, 2007, pages 2151 - 2157, XP002533527, DOI: 10.1158/1078-0432.CCR-06-2746
OHIGASHI Y ET AL.: "Clinical significance of programmed death-1 ligand-1 and programmed death-1 ligand 2 expression in human esophageal cancer", CLIN. CANCER RESEARCH, vol. 11, 2005, pages 2947 - 2953, XP002419631, DOI: 10.1158/1078-0432.CCR-04-1469
INMAN ET AL.: "PD-L1 (B7-H1) expression by urothelial carcinoma of the bladder and BCG-induced granulomata: associations with localized stage progression", CANCER, vol. 109, 2007, pages 1499 - 1505
SHIMAUCHI T ET AL.: "Augmented expression of programmed death-1 in both neoplasmatic and nonneoplastic CD4+ T-cells in adult T-cell Leukemia/Lymphoma", INT. J. CANCER, vol. 121, 2007, pages 2585 - 2590
GAO ET AL.: "Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma", CLINICAL CANCER RESEARCH, vol. 15, 2009, pages 971 - 979
NAKANISHI J.: "Overexpression ofB7-Hl (PD-Ll) significantly associates with tumor grade and postoperative prognosis in human urothelial cancers", CANCER IMMUNOL IMMUNOTHER., vol. 56, 2007, pages 1173 - 1182, XP019514169, DOI: 10.1007/s00262-006-0266-z
HINO ET AL.: "Tumor cell expression of programmed cell death-1 is a prognostic factor for malignant melanoma", CANCER, vol. 116, 2010, pages 1757 - 1766, XP009160407, DOI: 10.1002/cncr.24899
GHEBEH H: "Foxp3+ tregs and B7-H1+/PD-1+ T lymphocytes co-infiltrate the tumor tissues of high-risk breast cancer patients: implication for immunotherapy", BMC CANCER, vol. 23, no. 8, February 2008 (2008-02-01), pages 57
AHMADZADEH M. ET AL.: "Tumor antigen-specific CD8 T cells infiltrating the tumor express high levels of PD-1 and are functionally impaired", BLOOD, vol. 114, 2009, pages 1537 - 1544, XP055648069
THOMPSON RH ET AL.: "PD-1 is expressed by tumor infiltrating cells and is associated with poor outcome for patients with renal carcinoma", CLINICAL CANCER RESEARCH, vol. 15, 2007, pages 1757 - 1761, XP055613062, DOI: 10.1158/1078-0432.CCR-06-2599
HIROSHI KIKUCHI ET AL.: "Liposome I -How to prepare and assay", CELL TECHNOLOGY, vol. 2, no. 9, 1983, pages 1136 - 1149
United States Pharmacopoeia (USP; "NCBI", Database accession no. NP 079515
See also references of EP 3970745A4
Attorney, Agent or Firm:
HASEGAWA Yoshiki et al. (JP)
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