Treatment of PD-L1-Positive Melanoma Using an Anti-PD-1 Antibody

a technology of pdl1 and anti-pd-1, which is applied in the field of treating pdl1-positive melanoma, to achieve the effect of reducing the size of the tumor

Inactive Publication Date: 2016-12-15
BRISTOL MYERS SQUIBB CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012]The present disclosure also provides a method for reducing a tumor size at least by 10% in a patient afflicted with a melanoma tumor comprising administering to the patient an anti-PD-1 antibody monotherapy, wherein the patient is identified

Problems solved by technology

However, unlike the clinical development of small molecule agents that target discrete activating mutations found in select cancer populations, a particular chal

Method used

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  • Treatment of PD-L1-Positive Melanoma Using an Anti-PD-1 Antibody
  • Treatment of PD-L1-Positive Melanoma Using an Anti-PD-1 Antibody
  • Treatment of PD-L1-Positive Melanoma Using an Anti-PD-1 Antibody

Examples

Experimental program
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Effect test

example 1

[0143]A randomized, double-blind, multicenter, phase 3 trial was conducted to evaluate the safety and efficacy of nivolumab alone or nivolumab combined with ipilimumab in comparison with ipilimumab alone in previously untreated metastatic melanoma.

Patients

[0144]Eligible patients had histologically confirmed stage III (unresectable) or stage IV melanoma, and no prior systemic treatment for unresectable or metastatic melanoma. Other eligibility criteria included an age of at least 18 years, an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 (indicating no symptoms) or 1 (indicating mild symptoms), measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1, availability of tissue collected from metastatic or unresectable tumors for the assessment of PD-L1 status, and known BRAF V600 mutation status (or consent to BRAF V600 mutation testing per local standards). Key exclusion criteria were presence of active brain metastases, ocular m...

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Abstract

The invention provides a method of treating a melanoma comprising (i) identifying a patient having a PD-L1 positive melanoma and (ii) administering to the patient an anti-PD-1 antibody or an antigen-binding portion thereof (“an anti-PD-1 antibody monotherapy”). The methods of the invention can extend progression-free survival for over 12 months and/or reduces the tumor size at least about 10%, about 20%, about 30%, about 40%, or about 50% compared to the tumor size prior to the administration.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application claims benefit to U.S. Provisional Application No. 62 / 153,954 filed Apr. 28, 2015, which is incorporated herein by reference in its entirety.REFERENCE TO A SEQUENCE LISTING SUBMITTED ELECTRONICALLY VIA EFS-WEB[0002]The instant application contains a Sequence Listing which has been submitted in ASCII format via EFS-Web, and is hereby incorporated by reference in its entirety. Said ASCII copy, created on Apr. 28, 2016, is named 3338_0320001_SeqListing_ST25.txt and is 3,696 bytes in size.[0003]Throughout this application, various publications are referenced in parentheses by author name and date, or by Patent No. or Patent Publication No. The disclosures of these publications are hereby incorporated in their entireties by reference into this application in order to more fully describe the state of the art as known to those skilled therein as of the date of the invention described and claimed herein. However, the citat...

Claims

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Application Information

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IPC IPC(8): C07K16/28G01N33/574
CPCC07K16/2803G01N33/5743C07K2317/21G01N2333/70532C07K2317/56C07K2317/565A61K2039/505C07K16/2818A61K2039/507A61K2039/545A61K2039/55A61P35/00A61P43/00A61K39/39558
Inventor YANG, ARVIN
Owner BRISTOL MYERS SQUIBB CO
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