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Maintenance therapy of a parp inhibitor in treating gastric cancer

A technology for inhibitors and gastric cancer, applied to medical preparations containing active ingredients, drug combinations, active ingredients of heterocyclic compounds, etc.

Pending Publication Date: 2021-01-29
百济神州(苏州)生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are currently no drugs approved for maintenance therapy after first-line therapy in advanced or metastatic gastric cancer
Maintenance therapy is required for those patients who have achieved complete remission (CR) or partial remission (PR) with initial platinum-based chemotherapy but have no further treatment options to consolidate or maintain clinical benefit from first-line chemotherapy

Method used

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  • Maintenance therapy of a parp inhibitor in treating gastric cancer
  • Maintenance therapy of a parp inhibitor in treating gastric cancer
  • Maintenance therapy of a parp inhibitor in treating gastric cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0035] Example A: Preclinical Studies

[0036] A Study of Pamiparib Versus Placebo as Maintenance Therapy in a BBGA087 Patient-Derived Xenograft Model of Gastric Cancer Responsive to Oxaliplatin

[0037] method

[0038] BBGA087 patient-derived gastric cancer tissue fragments (3 × 3 × 3 mm3) were implanted subcutaneously in the right flank of female nod-scid mice. After inoculation, tumor volume and body weight were measured twice a week and calculated with the formula: V=0.5×(a×b2), where a and b are the long and short diameters of the tumor, respectively. When the average tumor size reached 200mm3, the animals were randomly divided into 3 groups. Animals were treated with vehicle (0.5% methylcellulose, 0.5% MC), pamiparib, oxaliplatin+5-fluorouracil (5-FU), respectively. BGB290 was given by oral gavage (p.o.) at 6 mg / kg twice a day (BID); oxaliplatin was given by intraperitoneal (i.p.) injection once a week (QW) for three weeks; and 5-FU was administered by intraperiton...

Embodiment B

[0053] Example B: Clinical Study

[0054] method

[0055] Overall Design and Research Objectives

[0056] A phase 3, double-blind, placebo-controlled, randomized, multicenter study was designed to compare the efficacy, safety of pamiparib versus placebo as maintenance therapy in patients with advanced gastric cancer responding to platinum-based first-line chemotherapy and tolerance ( image 3 ).

[0057] The primary objective was to evaluate the maintenance efficacy of pamiparib compared to placebo in terms of progression-free survival (PFS) as assessed by a blinded independent review committee (BIRC).

[0058] Secondary objectives would include pamiparib versus placebo in other efficacy assessments (overall survival [OS]; investigator-assessed PFS; PFS at 2 years [PFS2]; time to second follow-up therapy [TSST ]; and Objective Response Rate [ORR], Duration of Response [DoR], and Time to Response, all assessed by the investigator) and a comparison of safety and tolerability...

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PUM

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Abstract

Disclosed herein is a method for maintenance therapy of a PARP inhibitor in treating a subject with gastric cancer (GC) comprising administering to the subject a therapeutic or maintenance effective amount of a PARP inhibitor, wherein the subject had previously received chemotherapy.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of International Patent Application No. PCT / CN2018 / 089564 filed on June 1, 2018, the disclosure of which is hereby incorporated by reference in its entirety for all purposes. technical field [0003] Disclosed herein is a method of PARP inhibitor maintenance therapy for treating a subject with gastric cancer (GC), comprising administering to the subject a therapeutically or maintenance effective amount of a PARP inhibitor, wherein the subject is The subjects had previously received chemotherapy. Background technique [0004] Gastric cancer is one of the most commonly diagnosed cancers and is one of the leading causes of cancer death worldwide. More than half of gastric cancer cases and deaths are estimated to occur in China, with about 680,000 cases and about 500,000 deaths in 2015 (Chen et al., 2016). The estimated number of deaths from gastric cancer in the European Union in 2017...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/551A61K31/55A61K31/502A61K31/435A61P35/00
CPCA61K31/502A61P35/00A61K31/55A61K31/551A61K31/454A61P35/04A61K31/513A61K31/555A61K45/06A61K33/243A61K2300/00
Inventor 蒋蓓蓓R·K·布拉曼张宇婷M·拉波尼H·法林汪来王鹤翔
Owner 百济神州(苏州)生物科技有限公司
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