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Methods of treating lung cancer with a pd-1 axis binding antagonist, an antimetabolite, and a platinum agent

An anti-metabolite, PD-L1 technology, applied in chemical instruments and methods, anti-animal/human immunoglobulin, antibody medical components, etc., can solve the problems of low survival rate of advanced NSCLC disease

Pending Publication Date: 2021-05-25
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Despite advances in new targeted therapies and new chemotherapy combinations, survival in advanced NSCLC disease remains poor and acquired resistance to targeted agents is a major clinical concern

Method used

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  • Methods of treating lung cancer with a pd-1 axis binding antagonist, an antimetabolite, and a platinum agent
  • Methods of treating lung cancer with a pd-1 axis binding antagonist, an antimetabolite, and a platinum agent
  • Methods of treating lung cancer with a pd-1 axis binding antagonist, an antimetabolite, and a platinum agent

Examples

Experimental program
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example

[0423] The present disclosure will be more fully understood with reference to the following examples. However, they should not be construed as limiting the scope of the invention. It should be understood that the examples and embodiments described herein are for illustrative purposes only, and various modifications or changes in view thereof will be suggested to those skilled in the art, and will be included within the spirit and scope of the application and the scope of the present invention. within the scope of the appended claims.

example 1

[0424] Example 1: Atezolizumab in combination with carboplatin + pemetrexed or cisplatin + pemetrexed in chemotherapy-naive patients with stage IV non-squamous non-small cell lung cancer+ (NSCLC)+ Phase III open-label randomized study comparing carboplatin-pemetrexed or cisplatin-pemetrexed

[0425]This study aimed to evaluate atezolizumab plus carboplatin+pemetrexed+or cisplatin+pemetrexed versus carboplatin+pemetrexed or cisplatin-pemetrexed for chemotherapy-naïve Comparison of efficacy, safety and pharmacokinetics in patients with stage IV non-squamous non-small cell lung cancer (NSCLC). The subsection outlines the specific goals and corresponding endpoints of the study.

[0426] Research objectives

[0427] The co-primary efficacy objectives of the study are as follows:

[0428] · Death from any cause according to RECIST v1.1 (see for example Eisenhauer et al., (2009) "Newresponsevaluation criteria in solid tumors: Revised RECIST guideline (Version 1.1)." EurJ Cancer.45...

example 2

[0628] Example 2: Efficacy of atezolizumab in combination with carboplatin-pemetrexed or cisplatin-pemetrexed as first-line therapy in key subgroups of patients with stage +IV+ non-squamous non-small cell lung cancer (NSCLC)

[0629] Based on the results described in Example 1, exploratory efficacy analyzes were performed on PFS and interim OS in clinically relevant patient subgroups (eg, race, age, smoking history, and baseline liver metastases).

[0630] 578 patients were enrolled. The median follow-up time was 14.8 months. Baseline characteristics were generally balanced between treatment groups. See Table 12 and Figure 5B , which are PFS and interim OS data in key subgroups.

[0631] Table 12: PFS and interim OS data in key subgroups

[0632]

[0633]

[0634] The addition of atezolizumab to carboplatin or cisplatin plus pemetrexed improved PFS and OS values ​​in most key clinical subgroups. The survival benefit appeared to be more pronounced in Asian patients,...

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Abstract

The present disclosure provides methods for treating lung cancer (such as non-small cell lung cancer, e.g., Stage IV non-squamous non-small cell lung cancer) in an individual. The methods comprise administering to the individual a PD-1 axis binding antagonist (such as an anti-PD-L1 antibody, e.g., atezolizumab), an antimetabolite (e.g., pemetrexed), and a platinum agent (e.g., cisplatin or carboplatin).

Description

[0001] Cross references to related patent applications [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 700,184, filed July 18, 2018, and U.S. Provisional Application No. 62 / 734,936, filed September 21, 2018, the contents of each of which are hereby incorporated by reference in their entirety . [0003] Submit a sequence listing as an ASCII text file [0004] The contents of the following submitted ASCII text file are hereby incorporated by reference in their entirety: Sequence Listing in Computer Readable Format (CRF) (file name: 146392045140SEQLIST.TXT, date of record: July 12, 2019, size: 37KB). technical field [0005] The present disclosure relates to PD-1 axis binding antagonists such as atezolizumab in combination with an antimetabolite such as pemetrexed and a platinum agent such as carboplatin or cisplatin Methods of treating cancer. Background technique [0006] Lung cancer remains the leading cause of cancer death worldwide, a...

Claims

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Application Information

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IPC IPC(8): A61K31/282A61K31/519A61K39/395A61P35/00C07K16/28
CPCA61P35/00A61K2039/505C07K16/2827A61K2039/545A61K2039/55A61K39/39558A61K31/519A61K45/06A61K31/513A61K31/52A61K31/7068A61K31/7076A61K31/555A61K2300/00A61K33/243A61K39/3955
Inventor G·香卡A·桑德勒D·S·陈林伟瑜
Owner F HOFFMANN LA ROCHE & CO AG
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