Spotlight on Antibody-Drug Conjugates
Spotlight on Antibody-Drug Conjugates
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Author: Niamh Buckley
Publisher: Datamonitor Healthcare
- Description
- Contents
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.
CONTENTS
6 OVERVIEW
7 KEY FINDINGS
8 INTRODUCTION TO ANTIBODY-DRUG CONJUGATES
8 The specific targeted nature of ADCs confers greater efficacy while also reducing toxicity
11 Bibliography
12 KEY PLAYERS IN THE ANTIBODY-DRUG CONJUGATE FIELD
12 Companies like ImmunoGen and Seattle Genetics are leaders in the field of ADCs
12 ImmunoGen
17 Seattle Genetics
22 Daiichi Sankyo
26 Bibliography
29 CURRENTLY APPROVED ANTIBODY-DRUG CONJUGATES
29 Five of the six currently approved ADCs are indicated for hematological malignancies
29 Mylotarg
32 Adcetris
35 Kadcyla
37 Besponsa
39 Lumoxiti
42 Polivy
44 Bibliography
48 PIPELINE TRENDS
48 Indications for ADCs
50 ADC target landscape
52 Combination studies
54 Success rates
56 The ADC late-stage pipeline is focused solely on solid tumors
60 Sacituzumab govitecan
61 Trastuzumab deruxtecan
65 Enfortumab vedotin
66 Bibliography
68 STRATEGIC INSIGHTS
68 Hitting the right target
68 Going for broad applicability
68 Targeting a niche disease/indication
68 Careful ADC design
69 Developing a biomarker-driven ADC
69 Managing toxicity
69 Standing out from the crowd
69 Adopting a combination strategy
70 Targeting disease areas beyond cancer
70 Balancing price with efficacy, safety, and QoL
LIST OF FIGURES
8 Figure 1: ADC design
12 Figure 2: Top 20 ADC companies by pipeline size, 2019
32 Figure 3: SWOT analysis of Mylotarg
33 Figure 4: SWOT analysis of Adcetris
36 Figure 5: SWOT analysis of Kadcyla
39 Figure 6: SWOT analysis of Besponsa
41 Figure 7: SWOT analysis of Lumoxiti
43 Figure 8: SWOT analysis of Polivy
48 Figure 9: ADC pipeline activity, preclinical phase through launch, 2019
49 Figure 10: ADC development by disease area, 2019
50 Figure 11: ADC pipeline activity by indication and phase, 2019
51 Figure 12: Top 10 ADC targets, by phase, 2019
55 Figure 13: Completed ADC trials by outcome
56 Figure 14: Reasons for ADC trial terminations
LIST OF TABLES
10 Table 1: Currently approved ADCs
14 Table 2: ImmunoGen’s ADC pipeline
16 Table 3: Select ImmunoGen deals
18 Table 4: Seattle Genetics’ ADC pipeline
20 Table 5: Seattle Genetics’ ADC collaborator pipeline
21 Table 6: Select Seattle Genetics deals
23 Table 7: Daiichi Sankyo’s ADC pipeline
25 Table 8: Select Daiichi Sankyo deals
31 Table 9: Key efficacy data for Mylotarg
34 Table 10: Adcetris – approved indications
35 Table 11: Key efficacy data for Adcetris
37 Table 12: Key efficacy data for Kadcyla
39 Table 13: Key efficacy data for Besponsa
42 Table 14: Key efficacy data for Lumoxiti
44 Table 15: Key efficacy data for Polivy
53 Table 16: Combination trials of ADCs and approved immune checkpoint inhibitors
58 Table 17: ADC candidates in Phase III development
61 Table 18: Key efficacy and safety data for sacituzumab govitecan
63 Table 19: Key efficacy and safety data for trastuzumab deruxtecan
66 Table 20: Key efficacy and safety data for enfortumab vedotin
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