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Use of FGFR inhibitors in FGFR genetically altered cancers to enhance patient response to immune checkpoint inhibitors in sequential treatment settings

An immune checkpoint, FGFR2 technology, in the field of using FGFR inhibitors in cancers with FGFR genetic alterations to enhance patient response to immune checkpoint inhibitors in a sequential therapy setting, addressing suboptimal clinical outcomes, mUC unmet treatment needs

Pending Publication Date: 2022-05-10
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinical outcomes with platinum-based chemotherapy or taxane chemotherapy and immunotherapy (checkpoint inhibitors) have been suboptimal and there is a significant unmet therapeutic need for mUC

Method used

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  • Use of FGFR inhibitors in FGFR genetically altered cancers to enhance patient response to immune checkpoint inhibitors in sequential treatment settings
  • Use of FGFR inhibitors in FGFR genetically altered cancers to enhance patient response to immune checkpoint inhibitors in sequential treatment settings
  • Use of FGFR inhibitors in FGFR genetically altered cancers to enhance patient response to immune checkpoint inhibitors in sequential treatment settings

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0097] Example 1. Clinical Research

[0098] In this analysis, the clinical response to prior and subsequent therapy in FGFR-positive patients with mUC in the pivotal phase 2 study of erdafitinib was evaluated.

[0099] Research overview:

[0100] This is a retrospective analysis of data collected from patients randomized to regimen 3 (erdafitinib 8 mg once daily) of the phase 2 multicentre open-label study of erdafitinib (BLC2001; NCT02365597). This Phase 2 study is described, for example, in Loriot Y et al., N Engl J Med. 2019;25;381(4):338-348, which is incorporated herein by reference.

[0101] Patients with established FGFR2 / 3 mutation / fusion, locally advanced and unresectable or metastatic urothelial carcinoma that progressed during or after ≥ 1 line of prior chemotherapy or within 12 months of adjuvant / neoadjuvant chemotherapy , or ineligible for cisplatin use and chemotherapy-naïve.

[0102] Investigators report prior systemic therapy and subsequent lines of erdafit...

example 2

[0140] Example 2. Clinical Research

[0141] BLC2002 (NCT03473743) was to evaluate the safety of erdafitinib plus cilimumab (an anti-PD-1 monoclonal antibody) in subjects with metastatic or locally advanced urothelial carcinoma with selected FGFR gene alterations , efficacy, pharmacokinetics and pharmacodynamics phase 1b-2 study.

[0142] Phase 1b is the dose-escalation portion of the study, in which two dosing arms of erdafitinib (standard and alternative) were explored, while the intravenous (IV) dose of cilimumab was fixed. In the standard arm (DL1, DL2, or DL2A), erdafitinib and cilimumab were started simultaneously on day 1 of cycle 1 (C1D1). In the replacement group (DL1B or DL2B), the administration of erdafitinib was started on C1D1, but cilimumab was administered on day 1 (C2D1) of the second cycle (C2D1) after 1 cycle (4 weeks) (also known as erdatinib The 28-day trial run of Tini) started.

[0143] Blood for immune cell analysis was collected at four time points ...

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Abstract

Embodiments of the present invention relate to a method of treating cancer in a patient comprising administering to the patient an immune checkpoint inhibitor wherein the patient has been diagnosed with a cancer having an FGFR genetic alteration and has been pre-treated with an FGFR inhibitor, such as Erdatinib.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Application No. 62 / 906,517, filed September 26, 2019, which is hereby incorporated by reference in its entirety for all purposes. technical field [0003] The present invention relates to methods of treating cancer using fibroblast growth factor receptor (FGFR) inhibitors. In particular, the present invention relates to methods of using FGFR inhibitors in cancers with genetically altered FGFRs to enhance patient response to immune checkpoint inhibitors in a sequential therapy setting. Background technique [0004] Urothelial carcinoma (UC) is the most common form of bladder cancer, and nearly 20% of patients with metastatic UC (mUC) have fibroblast growth factor receptor (FGFR) gene alterations. The clinical outcomes of platinum-based chemotherapy or taxane chemotherapy and immunotherapy (checkpoint inhibitors) have been suboptimal and there is a significant unmet t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K45/06A61K31/498A61P35/00A61P35/04
CPCA61K39/39558A61K45/06A61K31/498A61P35/00A61P35/04C07K16/2818C07K16/2827A61K2039/545A61K2300/00A61K2039/505A61P13/02C07K2317/24
Inventor W·S·沙拉比A·E·圣地亚哥-沃克尔R·维罗纳E·祖代尔
Owner JANSSEN PHARMA NV
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