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Combination immunotherapy for treatment of triple-negative breast cancer

A triple-negative breast cancer and therapeutic agent technology, applied in breast cancer vaccines, immunoglobulins, anti-animal/human immunoglobulins, etc., can solve problems such as no proven effective targeted therapy

Pending Publication Date: 2021-10-22
エスエルエスジーリミテッドエルエルシー
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nonetheless, no targeted therapy, chemotherapy, or immunotherapy has been shown to be effective in the adjuvant / maintenance setting (i.e., after completion of first-line therapy) in delaying or preventing this relapse

Method used

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  • Combination immunotherapy for treatment of triple-negative breast cancer
  • Combination immunotherapy for treatment of triple-negative breast cancer
  • Combination immunotherapy for treatment of triple-negative breast cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0171] Example 1 - Trastuzumab plus Nelipepimut-S (NEUVAX) versus Trastuzumab for the prevention of relapse Prespecified interim analysis comparison of randomized phase 2b trial showing benefit in triple negative (HER2 low expressing) breast cancer patients place .

[0172] Breast cancer with low expression of human epidermal growth factor receptor 2 (HER2) (immunohistochemistry (IHC) 1-2+) is not suitable for adjuvant trastuzumab (TZ) therapy. NSABP B-47 demonstrated that trastuzumab does not improve prognosis in breast cancer with low HER2 expression (Fehrenbacher et al., SABCS, 2017, Abstract GS1-02). These patients currently do not have access to HER2-targeted therapies. TZ is the best known example of successful targeted therapy of cancer. 15-20% of BC patients are eligible to receive TZ because they are HER2 overexpressed (amplified by IHC3+ or FISH).

[0173] Efforts to expand the use of trastuzumab have been undertaken previously. More recently, the NSABP B-47...

Embodiment 2

[0218] Example 2—Activity of NPS in HLA-A24+ triple negative (HER2 low expression) breast cancer patients

[0219] In patients in the triple-negative breast cancer (TNBC) cohort (n=97) of this study (Example 1), aggressive treatment (NPS plus trastuzumab) benefited all HLA types (see Figure 8 , showing a sample plot of hazard ratios for patients of various HLA subtypes in the trial, where the overall hazard ratio [H.R.] for the TNBC cohort—across all HLA types—was an impressive 0.29). However, subgroup analysis of this panel showed that the H.R. was lowest in HLA-A24+ patients with a striking H.R. value of 0.08 and a p-value of 0.003. HLA-A24 positivity was particularly associated with Asian / Pacific Basin populations.

[0220] exist Figure 9 In , DFS of HLA-A24+TNBC patients is shown. In a later subgroup of TNBC patients, the NPS plus trastuzumab combination caused relapse at 24 months relative to the control group (trastuzumab only) in the 24-month DFS landmark analysi...

Embodiment approach 1

[0247] Embodiment 1. A method for treating triple negative breast cancer (TNBC) in an individual comprising administering to the individual: (a) an effective amount of trastuzumab or a derivative thereof; and (b) An effective amount of nelipepimut-S or a variant thereof.

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Abstract

The present invention concerns a method for treating triple-negative breast cancer (TNBC) in an individual, and / or for inducing an immune response to HER2 / neu in an individual with a triple-negative breast cancer expressing low levels of HER2 / neu, the method comprising administering to the individual: (a) an effective amount of trastuzumab, or derivative thereof; and (b) an effective amount of nelipepimut-S, or variant thereof, optionally with an immunological adjuvant. Preferably, the method includes a preparatory or priming phase comprising a frequency and duration of trastuzumab or trastuzumab derivative administration sufficient to substantially increase the major histocompatibility complex (MHC)-mediated presentation of HER2 peptide fragments to the patient immune system. The invention also includes medicaments and kits for treating TNBC in an individual, and / or for inducing an immune response to HER2 / neu in an individual with a TNBC expressing HER2 / neu.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Application Serial No. 62 / 855,650, filed May 31, 2019, and U.S. Provisional Application Serial No. 62 / 748,511, filed October 21, 2018, the entire contents of which are hereby incorporated by reference Incorporated herein, including any figures, tables, nucleic acid sequences, amino acid sequences or figures. Background technique [0003] The current standard of care for breast cancer includes screening tumors for expression levels of hormone receptors (estrogen receptor (ER) and progesterone receptor (PR)) and human epidermal growth factor receptor 2 (HER2) kinase. Women diagnosed with breast cancer can undergo initial treatment with surgery, chemotherapy (optional in some cases), and radiation therapy before starting targeted therapy. [0004] Patients with hormone receptor-positive breast cancer respond to selective estrogen receptor modulators or SERMs (eg, tamo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P35/00C07K14/47C07K16/18G01N33/53
CPCA61P35/00C07K2317/24C07K16/32A61K2039/505A61K39/3955A61K39/001106A61K2039/812A61K2039/55516C07K2317/73A61K9/0019A61K2300/00A61K39/39A61K39/39558A61K2039/54A61K2039/545A61K2039/55522A61K38/08A61K45/06
Inventor G·E·皮普尔斯A·M·斯特吉奥N·J·萨利斯
Owner エスエルエスジーリミテッドエルエルシー
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