CONTENTS
8 OVERVIEW
8 Latest key takeaways
10 DISEASE BACKGROUND
10 Definition
10 Risk factors
12 Symptoms
12 Diagnosis
12 Determination of HER2 status
13 Patient segmentation
14 TREATMENT
14 Referral patterns
14 Operable Stage I-III HER2+ breast cancer
14 Inoperable Stage III HER2+ breast cancer
14 Neoadjuvant/adjuvant therapy regimens
15 Treatment guidelines for Stage IV or recurrent HER2+ breast cancer
18 EPIDEMIOLOGY
21 Breast cancer subtypes
23 MARKETED DRUGS
30 PIPELINE DRUGS
43 KEY REGULATORY EVENTS
43 England's NICE Says Yes To Kadcyla In Early Breast Cancer
43 Seattle Genetics Wins Early US FDA Approval For Tukysa, Plans Rapid Launch
43 Japan Enhertu Nod Another Boost For Daiichi's Oncology Hopes
43 Ide-Cel and Enhertu Sponsors Keep Fingers Crossed For EMA Fast-Track
44 India's SPARC Keeps Paclitaxel Ambition Burning For Now
44 Assessment Aid Speeds FDA Review Of Nerlynx In Third-Line Breast Cancer
44 Seattle Genetics' Tucatinib Moves Quickly From BTD To NDA
44 Enhertu Earns Second-Fastest Review Time Of 2019
45 First Filing, In Japan, For Daiichi's Lead ADC As Others Progress
45 FDA Approves Amgen And Allergan's Kanjinti Trastuzumab Biosimilar
46 PROBABILITY OF SUCCESS
47 CLINICAL TRIAL LANDSCAPE
48 Sponsors by status
49 Sponsors by phase
50 Recent events
52 DRUG ASSESSMENT MODEL
54 MARKET DYNAMICS
55 FUTURE TRENDS
55 Launches of new targeted therapies and label expansions will drive growth in the HER2+ breast cancer market over the
forecast period
55 Uptake of combination regimens will drive high revenues
55 Pipeline drugs will face strong competition in a saturated market
56 Trastuzumab biosimilars will have a minor impact on the overall market
57 CONSENSUS FORECASTS
62 RECENT EVENTS AND ANALYST OPINION
62 Tukysa for Breast Cancer (May 29, 2020)
63 Kadcyla for Breast Cancer (May 13, 2020)
65 Onzeald for Breast Cancer (February 27, 2020)
66 Leronlimab for Breast Cancer (January 31, 2020)
67 Oral Paclitaxel for Breast Cancer (December 13, 2019)
68 Perjeta/Herceptin SQ FDC for Breast Cancer (December 12, 2019)
68 Enhertu for Breast Cancer (December 11, 2019)
70 Tukysa for Breast Cancer (December 11, 2019)
71 MCLA-128 for Breast Cancer (October 23, 2019)
72 Margetuximab for Breast Cancer (October 22, 2019)
74 Tukysa for Breast Cancer (October 21, 2019)
75 Verzenio for Breast Cancer (September 28, 2019)
77 Oral Paclitaxel for Breast Cancer (August 7, 2019)
78 Multiple Drugs for Breast Cancer (June 25, 2019)
79 Margetuximab for Breast Cancer (June 4, 2019)
80 Nerlynx for Breast Cancer (June 4, 2019)
82 Perjeta for Breast Cancer (June 2, 2019)
84 KEY UPCOMING EVENTS
86 KEY OPINION LEADER INSIGHTS
87 UNMET NEEDS
88 BIBLIOGRAPHY
89 Prescription information
91 APPENDIX
LIST OF FIGURES
13 Figure 1: Staging of HER2+ breast cancer
20 Figure 2: Trends in incident cases of breast cancer, 2018-27
30 Figure 3: Overview of pipeline drugs for breast cancer in the US
30 Figure 4: Pipeline drugs for breast cancer, by company
31 Figure 5: Pipeline drugs for breast cancer, by drug type
31 Figure 6: Pipeline drugs for breast cancer, by classification
46 Figure 7: Probability of success in the breast cancer pipeline
47 Figure 8: Clinical trials in breast cancer
47 Figure 9: Top 10 drugs for clinical trials in breast cancer
48 Figure 10: Top 10 companies for clinical trials in breast cancer
48 Figure 11: Trial locations in breast cancer
49 Figure 12: Breast cancer trials status
50 Figure 13: Breast cancer trials sponsors, by phase
52 Figure 14: Datamonitor Healthcare's drug assessment summary for HER2+ breast cancer
54 Figure 15: Market dynamics for HER2+ breast cancer
55 Figure 16: Future trends in HER2+ breast cancer
63 Figure 17: Tukysa for Breast Cancer (May 29, 2020): Phase II - HER2CLIMB
65 Figure 18: Kadcyla for Breast Cancer (May 13, 2020): Phase III - KAITLIN (w/Perjeta, HER2+)
70 Figure 19: Enhertu for Breast Cancer (December 11, 2019): Phase II - DESTINY-Breast01 (HER2+)
74 Figure 20: Margetuximab for Breast Cancer (October 22, 2019): Phase III - SOPHIA (HER2+)
75 Figure 21: Tukysa for Breast Cancer (October 21, 2019): Phase II - HER2CLIMB
77 Figure 22: Verzenio for Breast Cancer (September 28, 2019): Phase II - monarcHER
78 Figure 23: Oral Paclitaxel for Breast Cancer (August 7, 2019): Phase III - KX-ORAX-001 (S. America)
80 Figure 24: Margetuximab for Breast Cancer (June 4, 2019): Phase III - SOPHIA (HER2+)
82 Figure 25: Nerlynx for Breast Cancer (June 4, 2019): Phase III - NALA - w/Xeloda vs. Tykerb/Xeloda (HER2+)
83 Figure 26: Perjeta for Breast Cancer (June 2, 2019): Phase III - CLEOPATRA
84 Figure 27: Key upcoming events in breast cancer (one of two)
85 Figure 28: Key upcoming events in breast cancer (two of two)
87 Figure 29: Unmet needs in HER2+ breast cancer
LIST OF TABLES
17 Table 1: Preferred branded treatments for HER2+ breast cancer
19 Table 2: Incident cases of breast cancer, 2018-27
21 Table 3: Five-year prevalent cases of breast cancer, 2018-27
22 Table 4: Breast cancer subtypes
24 Table 5: Marketed drugs for HER2+ breast cancer
32 Table 6: Pipeline drugs for HER2+ breast cancer in the US
58 Table 7: Historical global sales, by drug ($m), 2015-19
60 Table 8: Forecasted global sales, by drug ($m), 2020-24
62 Table 9: Tukysa for Breast Cancer (May 29, 2020)
64 Table 10: Kadcyla for Breast Cancer (May 13, 2020)
65 Table 11: Onzeald for Breast Cancer (February 27, 2020)
66 Table 12: Leronlimab for Breast Cancer (January 31, 2020)
67 Table 13: Oral Paclitaxel for Breast Cancer (December 13, 2019)
68 Table 14: Perjeta/Herceptin SQ FDC for Breast Cancer (December 12, 2019)
69 Table 15: Enhertu for Breast Cancer (December 11, 2019)
71 Table 16: Tukysa for Breast Cancer (December 11, 2019)
72 Table 17: MCLA-128 for Breast Cancer (October 23, 2019)
73 Table 18: Margetuximab for Breast Cancer (October 22, 2019)
74 Table 19: Tukysa for Breast Cancer (October 21, 2019)
76 Table 20: Verzenio for Breast Cancer (September 28, 2019)
77 Table 21: Oral Paclitaxel for Breast Cancer (August 7, 2019)
78 Table 22: Multiple Drugs for Breast Cancer (June 25, 2019)
79 Table 23: Margetuximab for Breast Cancer (June 4, 2019)
81 Table 24: Nerlynx for Breast Cancer (June 4, 2019)
83 Table 25: Perjeta for Breast Cancer (June 2, 2019)