表紙
市場調查報告書

對ADC (抗體-藥物複合體) 的關注

Spotlight on Antibody-Drug Conjugates

出版商 Datamonitor Healthcare 商品編碼 912157
出版日期 內容資訊 英文 71 Pages
商品交期: 最快1-2個工作天內
價格
對ADC (抗體-藥物複合體) 的關注 Spotlight on Antibody-Drug Conjugates
出版日期: 2019年09月20日內容資訊: 英文 71 Pages
簡介

本報告提供ADC (抗體-藥物複合體) 市場相關調查,市場概要,主要企業,主要的已通過核准ADC,開發平台趨勢,及策略等相關分析。

概要

主要調查結果

ADC的簡介

  • ADC的個別標的化的性質造成毒性削減與同時有很大的效果
  • 參考資料

ADC領域的主要企業

  • ImmunoGen 和 Seattle Genetics 等企業牽引ADC領域
  • ImmunoGen
  • Seattle Genetics
  • 第一三共
  • 參考資料

現在,已通過核準的ADC

  • 現在已通過核準的ADC的6個中有5個適用骨髓惡性腫瘤
  • Mylotarg
  • Adcetris
  • Kadcyla
  • Besponsa
  • Lumoxiti
  • Polivy

開發平台趨勢

  • ADC的適應
  • ADC標的情勢
  • 並用研究
  • 成功率
  • ADC的後期階段開發平台著重固態腫瘤
  • Sacituzumab govitecan
  • Trastuzumab deruxtecan
  • Enfortumab vedotin
  • 參考資料

策略考察

  • 達到正確的目標
  • 尋求廣泛的適用性
  • 以最適合的疾病/適應症為目標
  • 慎重的ADC設計
  • 開發生物標記物驅動的ADC
  • 毒性的管理
  • 在多數人中突出
  • 並用策略的採用
  • 針對癌症以外的疾病領域
  • 價格和效果,保持安全性及QoL的平衡
目錄
Product Code: DMKC0208374

Overview

The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.

ADC development has historically not been without its setbacks. While the concept of delivering a potent cytotoxic payload directly to tumor cells and causing minimum damage to non-tumor cells was viewed as a significant advance towards precision medicine, the concept has proved difficult to translate into the clinic. Despite the obvious conceptual advantages to ADCs, toxicity, including accumulation during long treatment durations, can still be challenging. Arguably the greatest setback related to toxicity for the ADC class was Mylotarg's withdrawal from the US market in

2010. Although US approval was reinstated in 2017, at a reduced dose and a revised fractionated dosing schedule, the withdrawal has up until relatively recently cast a shadow over the class. However, based on recent approvals and the robust pipeline, it is clear that the clouds are lifting for the ADC class.

The recent resurgence in ADC development coincides with improvements in ADC platforms, linker technologies, and new applications such as combination approaches with immunotherapy and chemotherapy to treat cancer. There is also a small but emerging trend to evaluate ADCs beyond the realm of oncology. The late-stage ADC pipeline is still, however, solely focused on oncology, specifically solid tumor indications.

TABLE OF CONTENTS

OVERVIEW

KEY FINDINGS

INTRODUCTION TO ANTIBODY-DRUG CONJUGATES

  • The specific targeted nature of ADCs confers greater efficacy while also reducing toxicity
  • Bibliography

KEY PLAYERS IN THE ANTIBODY-DRUG CONJUGATE FIELD

  • Companies like ImmunoGen and Seattle Genetics are leaders in the field of ADCs
  • ImmunoGen
  • Seattle Genetics
  • Daiichi Sankyo
  • Bibliography

CURRENTLY APPROVED ANTIBODY-DRUG CONJUGATES

  • Five of the six currently approved ADCs are indicated for hematological malignancies
  • Mylotarg
  • Adcetris
  • Kadcyla
  • Besponsa
  • Lumoxiti
  • Polivy
  • Bibliography

PIPELINE TRENDS

  • Indications for ADCs
  • ADC target landscape
  • Combination studies
  • Success rates
  • The ADC late-stage pipeline is focused solely on solid tumors
  • Sacituzumab govitecan
  • Trastuzumab deruxtecan
  • Enfortumab vedotin
  • Bibliography

STRATEGIC INSIGHTS

  • Hitting the right target
  • Going for broad applicability
  • Targeting a niche disease/indication
  • Careful ADC design
  • Developing a biomarker-driven ADC
  • Managing toxicity
  • Standing out from the crowd
  • Adopting a combination strategy
  • Targeting disease areas beyond cancer
  • Balancing price with efficacy, safety, and QoL

LIST OF FIGURES

  • Figure 1: ADC design
  • Figure 2: Top 20 ADC companies by pipeline size, 2019
  • Figure 3: SWOT analysis of Mylotarg
  • Figure 4: SWOT analysis of Adcetris
  • Figure 5: SWOT analysis of Kadcyla
  • Figure 6: SWOT analysis of Besponsa
  • Figure 7: SWOT analysis of Lumoxiti
  • Figure 8: SWOT analysis of Polivy
  • Figure 9: ADC pipeline activity, preclinical phase through launch, 2019
  • Figure 10: ADC development by disease area, 2019
  • Figure 11: ADC pipeline activity by indication and phase, 2019
  • Figure 12: Top 10 ADC targets, by phase, 2019
  • Figure 13: Completed ADC trials by outcome
  • Figure 14: Reasons for ADC trial terminations

LIST OF TABLES

  • Table 1: Currently approved ADCs
  • Table 2: ImmunoGen's ADC pipeline
  • Table 3: Select ImmunoGen deals
  • Table 4: Seattle Genetics' ADC pipeline
  • Table 5: Seattle Genetics' ADC collaborator pipeline
  • Table 6: Select Seattle Genetics deals
  • Table 7: Daiichi Sankyo's ADC pipeline
  • Table 8: Select Daiichi Sankyo deals
  • Table 9: Key efficacy data for Mylotarg
  • Table 10: Adcetris - approved indications
  • Table 11: Key efficacy data for Adcetris
  • Table 12: Key efficacy data for Kadcyla
  • Table 13: Key efficacy data for Besponsa
  • Table 14: Key efficacy data for Lumoxiti
  • Table 15: Key efficacy data for Polivy
  • Table 16: Combination trials of ADCs and approved immune checkpoint inhibitors
  • Table 17: ADC candidates in Phase III development
  • Table 18: Key efficacy and safety data for sacituzumab govitecan
  • Table 19: Key efficacy and safety data for trastuzumab deruxtecan
  • Table 20: Key efficacy and safety data for enfortumab vedotin