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Methods for treating cancer with anti-PD-1 antibodies

A PD-1, cancer technology, applied in the direction of antibody medical components, antibodies, chemical instruments and methods, can solve problems such as impaired immune response

Pending Publication Date: 2020-09-25
MERCK SHARP & DOHME BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, PD-L1 expressing tumor cells have been proposed to interact with PD-1 expressing T cells to attenuate T cell activation and evade immune surveillance, resulting in impaired immune responses against tumors

Method used

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  • Methods for treating cancer with anti-PD-1 antibodies
  • Methods for treating cancer with anti-PD-1 antibodies
  • Methods for treating cancer with anti-PD-1 antibodies

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0262] Six-times-weekly (Q6W) dosing schedule for pembrolizumab across multiple tumor types based on assessments using modeling and simulation

[0263] Pembrolizumab, an anti-PD-1 checkpoint inhibitor currently approved for use in multiple cancer indications, has demonstrated safety and efficacy when administered at doses of 200 mg or 2 mg / kg Q3W. Alternative extended dosing regimens would provide convenience and flexibility benefits to both patients and prescribers. Robust characterization of pembrolizumab pharmacokinetics (PK) and exposure (concentration)-response (E-R) relationships for both efficacy and safety allows model-based approaches to support alternative dosing regimens for pembrolizumab .

[0264] Dosing for the Q6W schedule of pembrolizumab was selected by matching exposure to approved Q3W (200 mg and 2 mg / kg) regimens after PK steady state was achieved; based on knowledge of the E-R, the efficacy between regimens was Build bridges with security. Using an esta...

Embodiment 2

[0270] A phase 1 randomized clinical study of pembrolizumab evaluating the safety and tolerability of intravenous infusion of 400 mg pembrolizumab Q6W in participants with advanced melanoma

[0271]The study was designed to evaluate the pharmacokinetics (PK), safety and tolerability of pembrolizumab when administered every 6 weeks (Q6W). Cohorts of 100 participants were given 400 mg of pembrolizumab Q6W. PK, potency and safety data are collected from this participant cohort. Male / female participants at least 18 years of age with advanced melanoma were enrolled in the study. Stratification based on age, sex, or other characteristics was not used in this study.

[0272] Participants received an IV infusion of 400 mg pembrolizumab Q6W from cycles 1 to 18. PK, potency and safety data were collected from these participants. The results provide preliminary PK, efficacy and safety data for pembrolizumab when administered Q6W. Based on a robust understanding of the clinical pharm...

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PUM

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Abstract

The present invention relates to methods for treating cancer in a patient comprising administering a PD-1 antagonist, e.g., an anti-PD-1 antibody or antigen binding fragment thereof (e.g. pembrolizumab), in specific amounts to the patient about every six weeks. In some embodiments, the amount of anti-PD-1 antibody or antigen binding fragment thereof is about 400 mg. In certain embodiments, the PD-1 antagonist is pembrolizumab, or an antigen binding fragment thereof. Also provided are compositions and kits comprising a dosage of an anti-PD-1 antibody, or antigen-binding fragment thereof, and uses thereof for treating cancer.

Description

[0001] field of invention [0002] The present invention relates to therapies useful in the treatment of cancer. In particular, the present invention relates to methods for treating cancer comprising administering an anti-PD-1 antibody or antigen-binding fragment thereof to a patient in need thereof using the dosage regimen specified herein. [0003] Cross References to Related Applications [0004] This application claims the benefit of U.S. Provisional Application No. 62 / 630,038, filed February 13, 2018, and U.S. Provisional Application No. 62 / 732,828, filed September 18, 2018, the contents of which are hereby incorporated by reference in their entirety. [0005] References to Sequence Listings Submitted Electronically [0006] The sequence listing of the present application was submitted electronically via EFS-Web as a sequence listing in ASCII format with the filename "24567WOPCT-SEQLIST-25JAN2019.TXT", a creation date of January 25, 2019, and a size of 23.7 kb. This Sequ...

Claims

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Application Information

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IPC IPC(8): A61K39/00A61K39/395A61K47/02A61K47/12
CPCA61K2039/545A61K2039/505A61P35/00C07K16/2818C07K2317/24C07K2317/76A61K31/519A61K31/555C07K2317/565A61K39/39541A61K47/22A61K47/26C07K2317/51C07K2317/515C07K2317/56
Inventor M·拉拉L·贾因李梦瑶
Owner MERCK SHARP & DOHME BV
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