Methods of treating lung cancer with a pd-1 axis binding antagonist, a platinum agent, and a topoisomerase ii inhibitor

A technology of topoisomerase and PD-L1, applied in chemical instruments and methods, antibody medical ingredients, medical preparations containing active ingredients, etc., can solve problems such as poor survival prospects

Pending Publication Date: 2021-03-30
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the majority (approximately 70%) of SCLC patients are diagnosed with extensive-stage disease (ES-SCLC) with poor survival prospects (median overall survival [OS] approximately 10 months) (Socinski et al. (2009 ). JClin Oncol. 27:4787-92)

Method used

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  • Methods of treating lung cancer with a pd-1 axis binding antagonist, a platinum agent, and a topoisomerase ii inhibitor
  • Methods of treating lung cancer with a pd-1 axis binding antagonist, a platinum agent, and a topoisomerase ii inhibitor
  • Methods of treating lung cancer with a pd-1 axis binding antagonist, a platinum agent, and a topoisomerase ii inhibitor

Examples

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example

[0459] The present disclosure will be understood in more detail 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 appended claims within the range.

example 1

[0460] Example 1: Carboplatin plus etoposide with or without atezolizumab (anti-PD-L1 antibody) in untreated patients with extensive-stage small cell lung cancer (ES-SCLC) in phase I / III, randomized, Double-blind, placebo-controlled study,

[0461] This study was designed to evaluate, compared with placebo, carboplatin, and etoposide, in chemotherapy-naive patients with ES-SCLC, when atezolizumab was given in combination with carboplatin and etoposide, the Whether antitumor effects in patients treated with atezolizumab would translate into statistically significant and clinically relevant improvements in PFS and OS. This study could assess the efficacy of atezolizumab in the ITT population and could assess exploratory immunization endpoints (such as but not limited to retrospectively assessed by PD-L1 expression) and their relationship to patient outcomes.

[0462] Research objectives

[0463] The primary efficacy goals of this study were as follows:

[0464] Evaluate the...

example 2

[0592] Example 2: Patient Reported Outcomes (PROs) from Example 1

[0593] Patients participating in the study described in Example 1 completed the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C30 (EORTC QLQ-C30) and Quality of Life Questionnaire LC13 (QLQ-LC13) at baseline and every three weeks thereafter. Analysis included change from baseline, cumulative distribution function curves for change to week 12, and time to deterioration (TTD). Clinical significance is based on a change from baseline of ≥10 points (score range 0 to 100).

[0594]Completion rates were ≥85% at baseline and ≥70% at week 75 in both arms of the study. Baseline patient-reported outcome scores were comparable between the two groups. Patients in both cohorts reported early, significant improvement in symptoms, with numbers tending to be greater for Atezo+CE compared to placebo+CE. See Table 11. By week 12, a higher proportion of patients receiving Atezo+CE...

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Abstract

The present disclosure provides methods for treating lung cancer (such as small cell lung cancer, e.g., extensive stage small cell lung cancer) in an individual. The methods comprise administering tothe individual a PD-1 axis binding antagonist (such as an anti-PD-L1 antibody, e.g., atezolizumab), a platinum agent (e.g., cisplatin or carboplatin), and a topoisomerase II inhibitor (e.g., etoposide).

Description

[0001] Cross references to related patent applications [0002] This application claims U.S. Provisional Application No. 62 / 689,105, filed June 23, 2018, U.S. Provisional Application No. 62 / 719,461, filed August 17, 2018, and U.S. Provisional Application No. 62 / 736,326, filed September 25, 2018 , the contents of each of these provisional applications 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: 146392044940SEQLIST.TXT, date of record June 18, 2019, size: 37KB). technical field [0005] The present disclosure relates to methods of treating cancer by administering a PD-1 axis binding antagonist such as atezolizumab in combination with a platinum agent such as carboplatin and an inhibitor of topoisomerase II such as etoposide. Ba...

Claims

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Application Information

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IPC IPC(8): C07K16/28A61K39/395A61K31/282A61K31/495C07K16/30C07K16/32
CPCC07K16/2827C07K16/3023C07K16/32A61K39/39558A61K39/3955A61K45/06A61K31/555A61K33/243A61K31/7048A61K31/704A61K31/136A61K31/473A61P35/00A61P35/04A61K2300/00A61K2039/505A61K9/0019A61K31/365
Inventor A·洛佩兹-查韦斯D·A·沃特坎普
Owner F HOFFMANN LA ROCHE & CO AG
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