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Immuno-oncology is an area of medicine that focuses on the development of therapies that improve the body’s ability to generate an immune response against cancer (Eggermont and Finn, 2012).
Description
This is an overview of the field of immuno-oncology and the various immuno-oncology classes. Immuno-oncology is one of the most promising and fastest growing areas of cancer research, as well as one of the most active areas in terms of licensing deals and acquisitions.
Highlights
The PD-1/PD-L1 inhibitor and TCR/CAR-T therapy drug classes lead development of all immuno-oncology drugs. However, several novel mechanisms of action are also in early-phase development.
Developers of approved PD-1/PD-L1 inhibitors – Bristol-Myers Squibb, Merck & Co, Roche, AstraZeneca, and Pfizer – currently dominate the immuno-oncology field in terms of the number of ongoing, conducted, and planned trials.
Furthermore, PD-1/PD-L1 inhibitors remain a focal point of immuno-oncology combinations, with various types of combination approaches being studied.
Methodology
Three key opinion leaders were interviewed for this analysis, with the full interviews being transcribed. A survey of 56 medical oncologists across the US and five major EU markets (France, Germany, Italy, Spain, and the UK) was also conducted. Pipeline data were provided by Biomedtracker and Pharmaprojects, clinical trial data were provided by Trialtrove, and deals information was provided by Strategic Transactions.
8 EXECUTIVE SUMMARY
9 IMMUNO-ONCOLOGY OVERVIEW
9 Overview of the immune system and tumor cells
10 Bibliography
12 CURRENT STATUS OF IMMUNO-ONCOLOGY DEVELOPMENT
12 Immuno-oncology trials by status
12 Immuno-oncology trials by phase
13 Immuno-oncology trials by disease
14 Immuno-oncology trials by company
15 Immuno-oncology trials by mechanism of action
16 Immuno-oncology trials by country
18 PD-1/PD-L1 INHIBITORS
18 Class description
18 Clinical development of PD-1/PD-L1 inhibitors
28 Deals
32 Bibliography
37 CTLA-4 INHIBITORS
37 Class description
37 Clinical development of CTLA-4 inhibitors
40 Deals
41 Bibliography
42 TCR AND CAR-T THERAPIES
42 Class description
44 Clinical development of TCR and CAR-T therapies
57 Deals
59 Bibliography
61 IDO INHIBITORS
61 Class description
61 Clinical development of IDO inhibitors
64 Deals
64 Bibliography
66 EMERGING DRUG CLASSES
66 CD40 agonists
67 CEA inhibitors
68 CSF1R inhibitors
71 GITR agonists
72 LAG3 inhibitors
73 OX40 agonists
74 TIGIT inhibitors
75 TIM3 inhibitors
76 VISTA inhibitors
76 Bibliography
79 BRISTOL-MYERS SQUIBB
79 Immuno-oncology portfolio
87 Deals
88 Bibliography
90 MERCK & CO
90 Immuno-oncology portfolio
95 Deals
98 Bibliography
100 ROCHE
100 Immuno-oncology portfolio
103 Deals
105 Bibliography
106 ASTRAZENECA
106 Immuno-oncology portfolio
109 Deals
110 Bibliography
111 PFIZER
111 Immuno-oncology portfolio
113 Deals
114 Bibliography
115 IMMUNO-ONCOLOGY COMBINATIONS
117 KOL SURVEY
121 KOL INTERVIEWS
121 KOL-1: anonymous US medical oncologist/hematologist
124 KOL-2: anonymous US medical oncologist
127 KOL-3: Dr David McDermott
LIST OF FIGURES
10 Figure 1: Receptors and ligands involved in cell surface-mediated molecular signaling systems that control immune response
12 Figure 2: Distribution of immuno-oncology trials, by trial status
13 Figure 3: Phase of planned and ongoing immuno-oncology trials, by trial status
14 Figure 4: Top 25 cancers/cancer sites included in immuno-oncology trials, segmented by trial phase
15 Figure 5: Top 25 industry sponsors of immuno-oncology trials, segmented by trial status
16 Figure 6: Top 25 mechanisms of action in immuno-oncology trials, segmented by trial status
17 Figure 7: Top 25 countries hosting immuno-oncology trials, segmented by trial status
18 Figure 8: PD-1 and PD-L1 inhibitors
28 Figure 9: Top 10 cancers/cancer sites included in clinical trials studying PD-1/PD-L1 inhibitors, segmented by trial status
28 Figure 10: Top 10 industry sponsors of trials studying PD-1/PD-L1 inhibitors, segmented by trial status
40 Figure 11: Top 10 cancers/cancer sites included in clinical trials studying CTLA-4 inhibitors, segmented by trial status
40 Figure 12: Top five industry sponsors of trials studying CTLA-4 inhibitors, segmented by trial status
43 Figure 13: Overview of Kymriah’s CAR-T technology
56 Figure 14: Top 10 cancers/cancer sites included in clinical trials studying TCR/CAR-T therapies, segmented by trial status
57 Figure 15: Top 10 industry sponsors of trials studying TCR/CAR-T therapies, segmented by trial status
63 Figure 16: Top 10 cancers/cancer sites included in clinical trials studying IDO inhibitors, segmented by trial status
64 Figure 17: Top five industry sponsors of trials studying IDO inhibitors, segmented by trial status
87 Figure 18: Top 10 cancers/cancer sites featured in trials sponsored or co-sponsored by Bristol-Myers Squibb, segmented by trial status
95 Figure 19: Top 10 cancers/cancer sites featured in trials sponsored or co-sponsored by Merck & Co, segmented by trial status
103 Figure 20: Top 10 cancers/cancer sites featured in trials sponsored or co-sponsored by Roche, segmented by trial status
109 Figure 21: Top 10 cancers/cancer sites featured in trials sponsored or co-sponsored by AstraZeneca, segmented by trial status
113 Figure 22: Top 10 cancers/cancer sites featured in trials sponsored or co-sponsored by Pfizer, segmented by trial status
115 Figure 23: Number of trials testing each immuno-oncology combination approach, segmented by trial status
116 Figure 24: Number of immuno-oncology combination trials featuring approved PD-1/PD-L1 inhibitors, segmented by combination type
LIST OF TABLES
19 Table 1: Overview of approved and pipeline PD-1/PD-L1 inhibitors
30 Table 2: Key deals related to PD-1/PD-L1 inhibitors, 2017
38 Table 3: Overview of approved and pipeline CTLA-4 inhibitors
41 Table 4: Key deals related to CTLA-4 inhibitors, 2017
45 Table 5: Overview of approved and pipeline TCR/CAR-T therapies
58 Table 6: Key deals related to TCR/CAR-T therapies, 2017
62 Table 7: Overview of pipeline IDO inhibitors
64 Table 8: Key deals related to IDO inhibitors, 2017
67 Table 9: Overview of pipeline CD40 agonists
68 Table 10: Overview of pipeline CEA inhibitors
70 Table 11: Overview of pipeline CSF1R inhibitors
72 Table 12: Overview of pipeline GITR agonists
73 Table 13: Overview of pipeline LAG3 inhibitors
74 Table 14: Overview of pipeline OX40 agonists
75 Table 15: Overview of pipeline TIGIT inhibitors
76 Table 16: Overview of pipeline TIM3 inhibitors
76 Table 17: Overview of pipeline VISTA inhibitors
80 Table 18: Overview of Bristol-Myers Squibb’s immuno-oncology portfolio
88 Table 19: Key deals related to Bristol-Myers Squibb, 2017
91 Table 20: Overview of Merck & Co’s immuno-oncology portfolio
96 Table 21: Key deals related to Merck & Co, 2017
101 Table 22: Overview of Roche’s immuno-oncology portfolio
104 Table 23: Key deals related to Roche, 2017
107 Table 24: Overview of AstraZeneca’s immuno-oncology portfolio
110 Table 25: Key deals related to AstraZeneca, 2017
112 Table 26: Overview of Pfizer’s immuno-oncology portfolio
114 Table 27: Key deals related to Pfizer, 2017
117 Table 28: Medical oncologists included in Datamonitor Healthcare’s immuno-oncology KOL survey, 2017
118 Table 29: Question 1
119 Table 30: Question 2
119 Table 31: Question 3
120 Table 32: Question 4
120 Table 33: Question 5
121 Table 34: Key opinion leader information
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