2019 Spotlight on Antibody-Drug Conjugates: Pipeline Trends, Strategic Insights, Key Players - ResearchAndMarkets.com

The "Spotlight on Antibody-Drug Conjugates" report has been added to ResearchAndMarkets.com's offering.

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.

Companies Mentioned

• Daiichi Sankyo
• ImmunoGen
• Seattle Genetics
• Select ImmunoGen

Key Topics Covered

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

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