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EP4171748
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| EP4171748 - PERTUZUMAB PLUS TRASTUZUMAB FIXED DOSE COMBINATION [Right-click to bookmark this link] | Status | Request for examination was made Status updated on 31.03.2023 Database last updated on 20.05.2024 | |
| Former | The international publication has been made Status updated on 07.01.2022 | ||
| Former | unknown Status updated on 06.10.2020 | Most recent event Tooltip | 20.09.2023 | New entry: Renewal fee paid | Applicant(s) | For all designated states Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 / US | For all designated states F. Hoffmann-La Roche AG Grenzacherstrasse 124 4070 Basel / CH | [2023/18] | Inventor(s) | 01 /
BADOVINAC-CRNJEVIC, Tanja 4070 Basel / CH | 02 /
FREDRIKSSON, Yu Chien 4070 Basel / CH | 03 /
HEESON, Sarah Welwyn Garden City Hertfordshire AL7 1TW / GB | 04 /
NIJEM, Ihsan Hamdi South San Francisco, California 94080-4990 / US | 05 /
KIRSCHBROWN, Whitney Paige South San Francisco, California 94080-4990 / US | 06 /
RESTUCCIA, Eleonora 4070 Basel / CH | [2023/18] | Representative(s) | Brodbeck, Michel, et al F. Hoffmann-La Roche AG Patent Department Grenzacherstrasse 124 4070 Basel / CH | [2023/18] | Application number, filing date | 20780840.3 | 11.09.2020 | [2023/18] | WO2020US50363 | Priority number, date | US202063045712P | 29.06.2020 Original published format: US 202063045712 P | US202063065795P | 14.08.2020 Original published format: US 202063065795 P | [2023/18] | Filing language | EN | Procedural language | EN | Publication | Type: | A1 Application with search report | No.: | WO2022005499 | Date: | 06.01.2022 | Language: | EN | [2022/01] | Type: | A1 Application with search report | No.: | EP4171748 | Date: | 03.05.2023 | Language: | EN | The application published by WIPO in one of the EPO official languages on 06.01.2022 takes the place of the publication of the European patent application. | [2023/18] | Search report(s) | International search report - published on: | EP | 06.01.2022 | Classification | IPC: | A61P35/00, C07K16/32, A61K39/395 | [2023/18] | CPC: |
A61P35/00 (EP,IL,KR,US);
C07K16/32 (EP,IL,KR,US);
A61K38/00 (IL,US);
A61K38/47 (KR);
C12N9/2474 (IL,US);
C12Y302/01035 (IL,KR,US);
A61K2039/505 (IL,US);
A61K2039/507 (EP,IL,KR);
A61K2039/54 (KR);
| Designated contracting states | AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR [2023/18] | Title | German: | KOMBINATION AUS PERTUZUMAB UND TRASTUZUMAB MIT FESTER DOSIS | [2023/18] | English: | PERTUZUMAB PLUS TRASTUZUMAB FIXED DOSE COMBINATION | [2023/18] | French: | ASSOCIATION À DOSE FIXE DE PERTUZUMAB ET DE TRASTUZUMAB | [2023/18] | Entry into regional phase | 30.01.2023 | National basic fee paid | 30.01.2023 | Designation fee(s) paid | 30.01.2023 | Examination fee paid | Examination procedure | 30.01.2023 | Examination requested [2023/18] | 30.01.2023 | Date on which the examining division has become responsible | 17.08.2023 | Amendment by applicant (claims and/or description) | Fees paid | Renewal fee | 30.01.2023 | Renewal fee patent year 03 | 20.09.2023 | Renewal fee patent year 04 |
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| Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court. | Cited in | International search | [I]WO2018136412 (GENENTECH INC [US], et al) [I] 1-37 * page 64, line 12 - line 14; examples 1,2; claims 1-100 * * page 714, column l, paragraph l - column r, paragraph 1 *; | [XI] - ANTOINETTE R TAN ET AL, "Abstract PD4-07: Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study", CANCER RESEARCH, (20200201), vol. 80, doi:10.1158/1538-7445.SABCS19-PD4-07Published, pages 1 - 5, XP055770310 [X] 1-4,6-9,13-17,24-29,32-37 * paragraph [methods] * [I] 1-37 DOI: http://dx.doi.org/10.1158/1538-7445.SABCS19-PD4-07Published | [XI] - WHITNEY P. KIRSCHBROWN ET AL, "Development of a Subcutaneous Fixed-Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose-Finding Study", THE JOURNAL OF CLINICAL PHARMACOLOGY, US, (20181219), vol. 59, no. 5, doi:10.1002/jcph.1362, ISSN 0091-2700, pages 702 - 716, XP055770323 [X] 1-4,6-9,13-17,24-29,32-37 * page 703, column r, paragraph l; figure I * * page 704, column l, paragraph l - column r, paragraph 1 * * page 705 * * page 714, column l, paragraph l - column r, paragraph 1 * [I] 1-37 DOI: http://dx.doi.org/10.1002/jcph.1362 | [T] - TAN ANTOINETTE R ET AL, "Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study", THE LANCET ONCOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 22, no. 1, doi:10.1016/S1470-2045(20)30536-2, ISSN 1470-2045, (20201221), pages 85 - 97, (20201221), XP086432209 DOI: http://dx.doi.org/10.1016/S1470-2045(20)30536-2 | by applicant | US4816567 | US4933294 | WO9105264 | US5183884 | US5401638 | US5480968 | US5821337 | WO9845479 | US6054297 | US6339142 | US6407213 | US6639055 | US6719971 | WO2004078140 | US6800738 | US6949245 | WO2006091871 | US7560111 | US2009202546 | US7879325 | US7981418 | US2018296470 | - WOLFF et al., "Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/Collegc of American Pathologists clinical practice guideline focused update", Arch Pathol Lab Med, (20180000), vol. 142, no. 11, pages 1364 - 82 | - SLAMON et al., "Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene", Science, (19870000), vol. 235, no. 4785, pages 177 - 182 | - SWAIN et al., "Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer", N Engl J Med, (20150000), vol. 372, no. 8, pages 724 - 34 | - GIANNI et al., "Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial", Lancet Oncol, (20120000), vol. 13, no. 1, doi:10.1016/S1470-2045(11)70336-9, pages 869 - 32, XP055052201 DOI: http://dx.doi.org/10.1016/S1470-2045(11)70336-9 | - VON MINCKWITZ et al., "Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer", N Engl J Med, (20170000), vol. 377, no. 2, doi:10.1056/NEJMoa1703643, pages 122 - 31, XP055473189 DOI: http://dx.doi.org/10.1056/NEJMoa1703643 | - POORTER et al., "Complications of an implantable venous access device (Port-a-Cath) during intermittent continuous infusion of chemotherapy", Eur J Cancer, (19960000), vol. 32A, no. 13, pages 2262 - 6 | - SHIVAKUMAR et al., "Catheter-associated thrombosis in patients with malignancy", J Clin Oncol, (20090000), vol. 27, no. 29, pages 4858 - 64 | - DE COCK et al., "A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer", Cancer Med, (20160000), vol. 5, no. 3, pages 389 - 97 | - JACKISCH et al., "HannaH phase III randomised study: Association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up", Eur J Cancer, (20160000), vol. 62, doi:10.1016/j.ejca.2016.03.087, pages 62 - 75, XP029596158 DOI: http://dx.doi.org/10.1016/j.ejca.2016.03.087 | - JACKISCH et al., "Subcutaneous vs intravenous trastuzumab for patients with ERBB2-positive early breast cancer: Final analysis of the HannaH phase 3 randomized clinical trial", JAMA Oncol, (20190000), vol. 5, no. 5, page e190339 | - PIVOT et al., "Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): An open-label randomised study", Lancet Oncol, (20130000), vol. 14, no. 10, pages 962 - 70 | - PIVOT et al., "Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: Final analysis of 488 patients in the international, randomized, two-cohort PrefHer study", Ann Oncol, (20140000), vol. 25, no. 10, pages 1979 - 87 | - GLIGOROV et al., "Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study", Eur J Cancer, (20170000), vol. 86, pages 230 - 90 | - DAVIES et al., "Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): Stage 1 analysis of a randomised phase 3 study", Lancet Oncol, (20140000), vol. 15, no. 3, pages 343 - 52 | - ASSOULINE et al., "Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia", Br J Clin Pharmacol, (20150000), vol. 80, no. 5, pages 1001 - 9 | - RUMMEL et al., "Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: Results from a prospective, randomized, open-label, crossover study (PrefMab", Ann Oncol, (20170000), vol. 28, no. 4, pages 836 - 42 | - KIIMMEL et al., "Subcutaneous trastuzumab and hyaluronidase-oysk with intravenous pertuzumab and docetaxcl in HER2-positive advanced breast cancer: Final analysis of the phase Illb, multicenter, open-label, single-arm MetaPHER study", Cancer Res, (20190000), vol. 20, pages 18 - 05 | - HALLER MF., "Converting intravenous dosing to subcutaneous dosing with recombinant human hyaluronidase", Pharm Technol, (20070000), vol. 31, no. 10, pages 118 - 32, XP009122858 | - BEAUTE et al., "Economic evaluation of immunoglobulin replacement in patients with primary antibody deficiencies", Clin Exp Immunol, (20100000), vol. 160, no. 2, pages 240 - 5 | - GARDULF, A., "Immunoglobulin treatment for primary antibody deficiencies: Advantages of the subcutaneous route", BioDrugs, (20070000), vol. 21, no. 2, pages 105 - 16 | - KIRSCHBROWN et al., "Development of a subcutaneous fixed-dose combination of pertuzumab and trastuzumab: Results from the phase lb dose-finding study", J Clin Pharmacol, (20190000), vol. 59, no. 5, pages 702 - 16 | - SEMBA, PNAS (USA), (19850000), vol. 82, pages 6497 - 6501 | - YAMAMOTO et al., Nature, (19860000), vol. 319, pages 230 - 234 | - "Genebank", Database accession no. X03363 | - GARRETT et al., Mol. Cell., (20030000), vol. 11, pages 495 - 505 | - CHO et al., Nature, (20030000), vol. 421, pages 756 - 760 | - FRANKLIN et al., Cancer Cell, (20040000), vol. 5, pages 317 - 328 | - PLOWMAN et al., Proc. Natl. Acad. Sci., (19930000), vol. 90, pages 1746 - 1750 | - KRAUS et al., PNAS (USA), (19890000), vol. 86, pages 9193 - 9197 | - SLIWKOWSKI et al., J. Biol. Chew., (19940000), vol. 269, no. 20, pages 14661 - 14665 | - JOHNS et al., J. Biol Chem., (20040000), vol. 279, no. 29, pages 30375 - 30384 | - "Peptide and Protein", Drug Delivery, Marcel Dekker, Inc., (19910000), pages 247 - 301 | - JONES, A., Adv. Drug Delivery Rev., (19930000), vol. 10, pages 29 - 90 | - STANCOVSKI et al., PNAS (USA), (19910000), vol. 88, pages 8691 - 8695 | - CHOTHIA, Lesk J. Mol. Biol., (19870000), vol. 196, pages 901 - 917 | - TANNER et al., Am. J. Pathol., (20000000), vol. 157, no. 5, pages 1467 - 1472 | - BELLA et al., J. Clin. Oncol., (20080000), vol. 26, page 22147 | - SIAS et al., J. Immunol. Methods, (19900000), vol. 132, pages 73 - 80 | - BOSE et al., Cancer Discov, (20130000), vol. 3, pages 1 - 14 | - STEPHENS et al., Nature, (20040000), vol. 431, pages 525 - 6 | - SHIGEMATSU et al., Cancer Res, (20050000), vol. 65, pages 1642 - 6 | - BUTTITTA et al., Int J Cancer, (20060000), vol. 119, pages 2586 - 91 | - LI et al., Oncogene, (20080000), vol. 27, pages 4702 - 11 | - SEQUIST et al., J Clin Oncol, (20100000), vol. 28, pages 3076 - 83 | - ARCILA et al., Clin Cancer Res, (20120000), vol. 18, pages 4910 - 8 | - GREULICH et al., Proc Natl Acad Sci USA, (20120000), vol. 109, pages 14476 - 81 | - HERTER-SPRIE et al., Front Oncol, (20130000), vol. 3, pages 1 - 10 | - AGNEW, Chem Intl. Ed Engl., (19940000), vol. 33, pages 183 - 186 | - KOHLER et al., Nature, (19750000), vol. 256, page 495 | - CARTER et al., PNAS (USA, (19920000), vol. 89, pages 4285 - 4289 | - HARRIS et al., Chromatography. B, (20010000), vol. 752, pages 233 - 245 | - FROST. G. I., "Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration", Expert Opinion on Drug Delivery, (20070000), vol. 4, doi:10.1517/17425247.4.4.427, pages 427 - 440, XP008177677 DOI: http://dx.doi.org/10.1517/17425247.4.4.427 | - WEISSMANN, B., "The transglycosylative action of testicular hyaluronidase", J. Biol. Chem., (19550000), vol. 216, pages 783 - 94 | - CHEMICAL ABSTRACTS, Database accession no. 75971-58-7 | - HUDZIAK et al., Proc. Natl. Acad. Sci. USA., (19870000), vol. 84, pages 7159 - 7163 | - SLAMON et al., Science, (19890000), vol. 244, pages 707 - 712 | - ISMAEL et al., "Subcutaneous versus intravenous administration of (neo)adiuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre randomised trial", Lancet Oncol, (20120000), vol. 13, no. 9, pages 869 - 78 | - GLIGOROV et al., "Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients", Eur J Cancer, (20170000), vol. 82, doi:10.1016/j.ejca.2017.05.010, pages 237 - 46, XP085149230 DOI: http://dx.doi.org/10.1016/j.ejca.2017.05.010 | - PIVOT et al., "Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study", Eur J Cancer, (20170000), vol. 82, doi:10.1016/j.ejca.2017.05.009, pages 230 - 6, XP085149229 DOI: http://dx.doi.org/10.1016/j.ejca.2017.05.009 | - PEGRAM et al., "Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers", Oncogene, (19990000), vol. 18, no. 13, doi:10.1038/sj.onc.1202526, pages 2241 - 51, XP000918221 DOI: http://dx.doi.org/10.1038/sj.onc.1202526 | - SWAIN et al., "Pertuzumab, trastuzumab. and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): A phase II, open-label, multicenter, multinational cardiac safety study", Ann Oncol, (20180000), vol. 29, no. 3, pages 646 - 53 | - SCHNEEWEISS et al., "Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: A randomized phase II cardiac safety study (TRYPHAENA", Ann Oncol, (20130000), vol. 24, no. 9, doi:10.1093/annonc/mdt182, pages 2278 - 84, XP055473044 DOI: http://dx.doi.org/10.1093/annonc/mdt182 | - LOIBL et al., "Dual HER -blockade with pertuzumab and trastuzumab in HER2-positive early breast cancer: A subanalysis of data from the randomized phase III GeparSepto trial", Ann Oncol, (20170000), vol. 28, no. 3, pages 497 - 504 | - HURVITZ et al., "Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): A randomised, open-label, multicentre, phase 3 trial", Lancet Oncol, (20180000), vol. 19, no. 1, doi:10.1016/S1470-2045(17)30716-7, pages 115 - 26, XP085325355 DOI: http://dx.doi.org/10.1016/S1470-2045(17)30716-7 | - PAPAKONSTANTINOU et al., "Efficacy and Safety of Tailored and Dose-Dense Adjuvant Chemotherapy and Trastuzumab for Resected HER2-positive Breast Cancer: Results From the Phase 3 PANTHER Trial", Cancer, (20200000), vol. 126, no. 6, pages 1175 - 82 | - LAMBERTINI et al., "Dose-dense Adjuvant Chemotherapy in HER2-positive Early Breast Cancer Patients Before and After the Introduction of Trastuzumab: Exploratory Analysis of the GIM2 Trial", Int J Cancer, (20200000), vol. 147, no. 1, pages 160 - 9 | - VON MINCKWITZ G, N Engl J Med, (20170000), vol. 377, pages 122 - 131 | - BASELGA J et al., N Engl J Med, (20120000), vol. 366, pages 109 - 119 |