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CN-121971642-A - Methods of treating HER2 positive locally advanced or previously untreated metastatic breast cancer

CN121971642ACN 121971642 ACN121971642 ACN 121971642ACN-121971642-A

Abstract

The present invention relates generally to methods of treating HER2 positive locally advanced or previously untreated metastatic breast cancer and in particular provides methods of treating a patient with HER2 positive, locally advanced or previously untreated metastatic breast cancer who has received prior treatment with a taxane using an anti-HER 2-maytansinoid conjugate (e.g., trastuzumab-eimerine).

Inventors

  • A - E - campaldino.
  • M Sa Mante
  • A. Stella Sark
  • M. SMITH
  • M. Pat

Assignees

  • 豪夫迈·罗氏有限公司

Dates

Publication Date
20260505
Application Date
20160527
Priority Date
20150530

Claims (10)

  1. 1. A method of treating HER2 positive locally advanced or previously untreated metastatic breast cancer, the method comprising administering to a patient having said breast cancer a therapeutically effective amount of an anti-HER 2-maytansinoid conjugate, wherein the patient has received prior treatment with a taxane.
  2. 2. The method of claim 1, wherein the administration occurs more than or equal to 6 months after the prior treatment of the taxane.
  3. 3. The method of claim 1 or 2, wherein the patient has received prior treatment with a taxane and at least one HER2 targeted therapy.
  4. 4. The method of claim 3, wherein the patient has received prior treatment with a taxane and trastuzumab.
  5. 5. The method of claim 4, wherein the patient has received prior treatment with a taxane, trastuzumab, and pertuzumab.
  6. 6. The method of any one of claims 1-5, wherein the prior treatment is administered in a supplemental setting.
  7. 7. The method of any one of claims 1-5, wherein the prior treatment is administered in a neoadjuvant setting.
  8. 8. The method of any one of the preceding claims, wherein the taxane is paclitaxel.
  9. 9. The method of claim 8, wherein the paclitaxel is administered at 80 mg/m2 intravenously once a week.
  10. 10. The method of claim 9, wherein the paclitaxel is administered for a minimum of 18 weeks.

Description

Methods of treating HER2 positive locally advanced or previously untreated metastatic breast cancer The application is a divisional application of Chinese patent application of which the application date is 2016, 5 and 27, the Chinese application number is 201680031816.8 and the application name is 'a method for treating HER2 positive local advanced or previously untreated metastatic breast cancer'. RELATED APPLICATIONS The present application claims the benefit of U.S. provisional patent application No. 62/168,809 at 35 u.s.c. ≡119 filed 5/30, the disclosure of which is hereby incorporated by reference in its entirety. Sequence listing The present application contains a sequence listing in ASCII format and is hereby incorporated by reference in its entirety. ASCII text files were created at 20, 5, 2016, named GNE-0423R1-WO Sequence listing. Txt and are 30,476 bytes in size. Technical Field The present invention relates to methods of treating HER2 positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer using an anti-HER 2-maytansinoid conjugate, such as trastuzumab-MCC-DM 1, wherein the patient has received prior treatment with a taxane. Background Breast cancer and HER2 targeted therapy Breast cancer is a highly significant cause of morbidity and mortality worldwide. Over 130 thousands of breast Cancer cases were diagnosed worldwide each year, with over 450,000 deaths being associated with the disease (Jemal a, bray F, center M, et al, global Cancer statistics CA Cancer J Clin, 2011; 61 (2): 69-90). HER2 (ErbB 2) receptor tyrosine kinases are members of the Epidermal Growth Factor Receptor (EGFR) family of transmembrane receptors. HER2 overexpression (hereinafter referred to as HER2 positive breast cancer) was observed in about 20% of human breast cancers, and it was involved in aggressive growth and poor clinical outcomes associated with these tumors (Slamon et al (1987) Science 235:177-182). HER2 protein overexpression can be determined using immunohistochemical-based evaluation of fixed tumor masses (Press MF, et al (1993) CANCER RES 53:4950-70). Trastuzumab (CAS 180288-69-1, hercetin), huMAb4D5-8, rhuMAb HER2, genentech) is a recombinant DNA-derived, igG1 kappa monoclonal antibody, which is a humanized version (US 5677171; US 5821337; US 6054297; US 6165464; US 6339142; US 6407213; US 6639055; US 6719971; US 6800738; US 7074404; Coussens et al (1985) Science 230:1132-9; Slamon et al (1989) Science 244:707-12; Slamon et al (2001) New Engl. J. Med. 344:783-792). of murine anti-HER 2 antibody (4D 5) that selectively binds the extracellular domain of HER2 with high affinity (kd=5 nM) in a cell-based assay, has been shown to inhibit proliferation (Hudziak et al (1989) Mol Cell Biol 9:1165-72; Lewis et al (1993) Cancer Immunol Immunother; 37:255-63; Baselga et al (1998) Cancer Res. 58:2825-2831). Trastuzumab of human tumor cells overexpressing HER2 in both in vitro assays and animals (LEWIS ET AL (1993) Cancer Immunol Immunother (4): 255-263; hotalling et al (1996) [ abstract ]. Proc. Annu MEETING AM Assoc CANCER RES; 37: pegram MD, et al (1997) [ abstract ] ]. Proc Am Assoc Cancer Res; 38:602; Sliwkowski et al (1999) Seminars in Oncology 26(4), Suppl 12:60-70; Yarden Y. and Sliwkowski, M. (2001) Nature Reviews: Molecular Cell Biology, Macmillan Magazines, Ltd., Vol. 2:127-137). HERCEPTIN was approved in 1998 for the treatment of patients with HER2 overexpressing metastatic Breast cancer who had received extensive prior anti-cancer therapy (Baselga et al (1996) J. Clin. Oncol. 14:737-744), and has been used since then in more than 300,000 patients in abstract (Slamon DJ, et al., N Engl J Med 2001;344:783-92; Vogel CL, et al., J Clin Oncol 2002;20:719-26; Marty M, et al., J Clin Oncol 2005;23:4265-74; Romond EH, et al., T N Engl J Med 2005;353:1673-84; Piccart-Gebhart MJ, et al., N Engl J Med 2005;353:1659-72; Slamon D, et al. [. Breast CANCER RES TREAT 2006, 100 (Suppl 1): 52). In 2006, FDA approved HERCEPTIN cube (Genentech inc.) as part of a treatment regimen containing doxorubicin (doxorubicin), cyclophosphamide (cyclophosphamide) and paclitaxel (paclitaxel) for adjuvant treatment of HER2 positive junction positive breast cancer patients. An alternative approach to antibody-targeted therapies is to use antibodies to specifically deliver cytotoxic drugs to antigen-expressing cancer cells. The antibody-drug conjugate, or ADC, is a monoclonal antibody that has been conjugated to a highly potent cytotoxic agent. ADC represents a novel method of conferring tumor selectivity to a systemically administered anti-tumor therapeutic agent. ADCs are designed to focus delivery of highly potent cytotoxic agents to tumor cells using tumor-specific and/or overexpressed surface antigens. The potential of this approach is to create a more favorable therapeutic window for such agents than can be achieved by their administration as free drugs. Maytansinoids (maytansinoids), a deriv