Adjuvant Treatment Of Her2-Positive Breast Cancer
Patent No. US11077189 (titled "Adjuvant Treatment Of Her2-Positive Breast Cancer") was filed by Hoffmann-La Roche Inc on Feb 28, 2018.
What is this patent about?
’189 is related to the field of adjuvant cancer therapy , specifically addressing the treatment of HER2-positive early breast cancer (eBC). The background involves the use of HER2-targeted therapies like trastuzumab in combination with chemotherapy to improve outcomes. However, there remains a need for more effective treatments to reduce the risk of recurrence and death in these patients.
The underlying idea behind ’189 is to enhance the efficacy of standard adjuvant therapy for HER2-positive eBC by adding pertuzumab, a HER2 dimerization inhibitor , to the existing regimen of trastuzumab and chemotherapy. The key insight is that by simultaneously blocking HER2 signaling through different mechanisms (trastuzumab and pertuzumab), a more complete and sustained inhibition of tumor growth and survival can be achieved, leading to improved disease-free survival.
The claims of ’189 focus on a method of increasing invasive disease-free survival (IDFS) at 3 years in HER2-positive eBC patients, without increasing cardiac toxicity. This involves administering anthracycline-based chemotherapy followed by a taxane in combination with intravenous pertuzumab and trastuzumab for a total of 52 weeks. The initial dose of pertuzumab is 840 mg followed every 3 weeks by 420 mg pertuzumab, and the initial dose of trastuzumab is 8 mg/kg followed every 3 weeks by 6 mg/kg trastuzumab.
In practice, the claimed method involves first selecting patients with HER2-positive eBC who are at high risk of recurrence (node-positive or hormone receptor-negative) and have a baseline LVEF of at least 55%. These patients then undergo surgery followed by the specified anthracycline-based chemotherapy regimen. After completing chemotherapy, they receive a taxane (docetaxel or paclitaxel) concurrently with pertuzumab and trastuzumab, both administered intravenously according to the specified dosing schedule for a year.
This approach differs from prior art by incorporating pertuzumab into the adjuvant treatment regimen. While trastuzumab targets the HER2 receptor, pertuzumab inhibits HER2 dimerization, thus blocking different signaling pathways. The combination aims to provide a more comprehensive blockade of HER2 signaling, leading to a greater reduction in the risk of invasive disease recurrence or death, while maintaining an acceptable safety profile, specifically without increasing cardiac toxicity.
How does this patent fit in bigger picture?
Technical landscape at the time
In the late 2010s when ’189 was filed, HER2-positive breast cancer treatment at a time when targeted therapies were becoming more prevalent. At a time when treatment strategies commonly relied on combinations of chemotherapy and HER2-targeted antibodies, such as trastuzumab. When clinical trials were essential for demonstrating the efficacy and safety of new treatment regimens, particularly in adjuvant settings.
Novelty and Inventive Step
The examiner withdrew rejections based on the inventor's declaration, statements, and persuasive arguments. The examiner agreed that there was no reasonable expectation that the claimed method would achieve increased invasive disease-free survival (iDFS) at 3 years from initial administration without increasing cardiac toxicity in high-risk breast cancer patients. The application included data showing that the claimed adjuvant treatment was effective in treating high-risk breast cancer (node-positive or hormone receptor-negative) patients with superior iDFS efficacy at 3 years from initial treatment without increased cardiac toxicity, which was not predicted by the prior art.
Claims
This patent contains 4 claims, with claim 1 being independent. The independent claim focuses on a method of increasing invasive disease-free survival in HER2-positive early breast cancer patients using a specific chemotherapy and antibody regimen. The dependent claims specify patient subgroups within the scope of the independent claim based on node positivity and hormone receptor status.
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Date
Description
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US11077189
- Application Number
- US15907718
- Filing Date
- Feb 28, 2018
- Status
- Granted
- Expiry Date
- Mar 14, 2039
- External Links
- Slate, USPTO, Google Patents