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Administration of pd-1 inhibitors for treating skin cancer

A PD-1, skin cancer technology, applied in the field of programmed death 1 inhibitors, can solve problems such as reducing the risk of CSCC recurrence

Pending Publication Date: 2021-10-08
REGENERON PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, there is an unmet need to reduce the risk of CSCC recurrence, especially in high-risk patients

Method used

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  • Administration of pd-1 inhibitors for treating skin cancer
  • Administration of pd-1 inhibitors for treating skin cancer
  • Administration of pd-1 inhibitors for treating skin cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] Example 1: A Clinical Trial Comparing Anti-PD-1 Antibodies to Placebo as Adjuvant Therapy for Postoperative and Post-Radiation CSCC Patients

[0110] This study was a randomized, placebo-controlled, double-blind, multicenter, phase 3 study comparing an anti-PD-1 antibody with placebo as adjuvant therapy in CSCC patients with a high risk of recurrent disease. Risk-related features, having completed surgery and postoperative radiation therapy (RT). The study population included CSCC patients with high-risk features for surgical pathology who had completed surgery and postoperative RT. see figure 1 .

[0111] An exemplary anti-PD-1 antibody used in this study is REGN2810 (also known as simiprimab, or H4H7798N as disclosed in US9987500), which is a fully human monoclonal anti-PD-1 antibody comprising SEQ ID NO: The heavy chain comprising the amino acid sequence of ID NO:9 and the light chain comprising the amino acid sequence of SEQ ID NO:10; the HCVR / LCVR amino acid seq...

Embodiment 2

[0147] Example 2: Clinical Trial of Administering Anti-PD-1 Antibody as Neoadjuvant Therapy for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

[0148] This study is a phase 2, single-arm, open-label, multicenter study of patients with CSCC stages II to IV (M0) who are candidates for surgery but have an increased risk of recurrence and and / or risk of defects or loss of function.

[0149] An exemplary anti-PD-1 antibody used in this study is REGN2810 (also known as simiprimab, or H4H7798N as disclosed in US9987500), which is a fully human monoclonal anti-PD-1 antibody comprising SEQ ID NO: The heavy chain comprising the amino acid sequence of ID NO:9 and the light chain comprising the amino acid sequence of SEQ ID NO:10; the HCVR / LCVR amino acid sequence pair comprising SEQ ID NO:1 / 2; and the HCVR / LCVR amino acid sequence comprising SEQ ID NO:3 to 8 Heavy and light chain CDR sequences.

[0150] Research purposes

[0151] The primary objective of this study was ...

Embodiment 3

[0196] For Phase 2 of the study, it was expected that administration of REGN2810 as adjuvant therapy would result in a reduced risk of subsequent disease recurrence or zero incidence of subsequent disease recurrence in CSCC patients who had completed surgery and post-operative RT and were at high risk of recurrence . Administration of adjuvant REGN2810 therapy to high-risk CSCC patients following surgery and RT is also expected to improve disease control. Example 3: Clinical Trial of Anti-PD-1 Antibody Administration in Patients with Metastatic or Unresectable Advanced Cutaneous Squamous Cell Carcinoma (CSCC)

[0197] This study is a phase 2, nonrandomized, 5-arm pivotal trial in patients with advanced CSCC.

[0198] An exemplary anti-PD-1 antibody used in this study is REGN2810 (also known as simiprimab, or H4H7798N as disclosed in US9987500), which is a fully human monoclonal anti-PD-1 antibody comprising SEQ ID NO: The heavy chain comprising the amino acid sequence of ID ...

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Abstract

The disclosure relates to methods for treating or inhibiting the growth of a tumor in a patient with a skin cancer, wherein the methods include administering to the patient a therapeutically effective amount of a programmed death 1 (PD-1 ) inhibitor (e.g., an antibody or antigen-binding fragment thereof that specifically binds PD-1, PD-L1, and / or PD-L2). In certain embodiments, the method includes administering to the patient a therapeutically effective amount of a PD-1 inhibitor as adjuvant treatment after the patient has completed surgery and optionally radiation therapy for skin cancer, such as CSCC, and is at high risk for disease recurrence. In certain embodiments, the method includes administering to the skin cancer patient a therapeutically effective amount of a PD-1 inhibitor as neoadjuvant treatment before planned surgery for skin cancer. In certain embodiments, the method includes administering to skin cancer patient a therapeutically effective amount of a PD-1 inhibitor as neoadjuvant treatment before planned surgery for skin cancer and subsequently administering to the patient a PD-1 inhibitor as adjuvant therapy after such surgery.

Description

technical field [0001] The present disclosure relates to methods for treating tumors or inhibiting tumor growth comprising selecting a patient with skin cancer and administering to the patient a therapeutically effective amount of a programmed death 1 (PD-1 ) inhibitor. Background technique [0002] Skin cancer is the most common cancer in the United States (Guy et al., Am. J. Prev. Med. 48:183-87, 2015). An estimated 5.4 million cases of non-melanoma skin cancers, including basal and squamous cell carcinomas, were diagnosed in the United States in 2012 (Rogers et al., JAMA Dermatol., 151(10):1081-86, 2015). In the United States, cutaneous squamous cell carcinoma (CSCC) is the second most common malignancy after basal cell carcinoma (BCC) (Karia et al., J.Am.Acad.Dermatol. 68:957-66, 2013). Chronic sun exposure is a major risk factor for non-melanoma skin cancer. [0003] CSCC is a malignant proliferation of epidermal keratinocytes with invasion of the dermis and is disti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P35/00A61K39/00A61K39/395
CPCA61K39/00A61P35/00C07K16/2818A61K2039/505A61K2039/545A61K2039/55A61K39/39
Inventor 马修·G·菲里伊斯雷尔·勒维
Owner REGENERON PHARM INC