CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Risk factors
10 Symptoms
10 Diagnosis
10 Patient segmentation
11 Prognosis
13 TREATMENT
13 Referral patterns
13 Operable Stage I–III TNBC
13 Inoperable Stage III TNBC
13 Recommended neoadjuvant/adjuvant chemotherapy regimens
14 Treatment guidelines for Stage IV or recurrent TNBC
16 EPIDEMIOLOGY
16 Incidence and prevalence methodology
19 Breast cancer subtypes
21 MARKETED DRUGS
28 PIPELINE DRUGS
46 KEY REGULATORY EVENTS
46 Reimbursement Rejection On Cost Grounds For “Highly Effective” Trodelvy In England
46 NICE Says No To Keytruda For Triple-Negative Breast Cancer
46 Scotland Okays First ILAP Drugs For Reimbursement
47 Gilead Sees Room For Trodelvy In European Markets
47 As TNBC Landscape Changes, Another ‘Dangling’ Accelerated Approval Falls
47 Keeping Track: Keytruda’s TNBC Label Grows
48 Roche Withdraws MAA For Tecentriq In Early Or Locally Advanced TNBC
49 PROBABILITY OF SUCCESS
50 LICENSING AND ASSET ACQUISITION DEALS
50 Gilead Opts In On Multiple Arcus IO Candidates, Setting Up Combo Therapy Plans
50 Sanofi Hopes Owkin Can Aid Oncology Discovery
50 Pyramid Licenses Voronoi’s MPS1 Kinase Inhibitor
51 Gilead and Merck & Co Collaborate On Trodelvy/Keytruda Breast Cancer Trial
51 GSK Exits $4.2bn Cancer Drug Deal With Merck KGaA After Multiple Failures
51 Merck KGaA Deal Gives Diaccurate New Lead Cancer Candidate
51 BMS, Eisai Team Up To Accelerate Development Of Solid-Tumor ADC
53 CLINICAL TRIAL LANDSCAPE
55 Sponsors by status
55 Sponsors by phase
56 Recent events
59 DRUG ASSESSMENT MODEL
62 MARKET DYNAMICS
63 FUTURE TRENDS
63 Approvals and subsequent uptake of new targeted therapies and immunotherapies will drive growth in the TNBC market
over the forecast period
63 Keytruda will overtake Tecentriq in the TNBC market during the forecast period
63 The PARP inhibitors will see significant use in the subset of TNBC patients with BRCA mutations over the forecast period
64 ADCs will dominate in the second-line and later setting over the forecast period
65 CONSENSUS FORECASTS
70 RECENT EVENTS AND ANALYST OPINION
70 Enhertu for Breast Cancer (February 21, 2022)
71 Veliparib for Breast Cancer (September 17, 2021)
72 Multiple Drugs for Breast Cancer (June 5, 2021)
73 Trodelvy for Breast Cancer (June 4, 2021)
74 Keytruda for Breast Cancer (May 13, 2021)
74 Tecentriq for Breast Cancer (April 27, 2021)
76 Tecentriq for Breast Cancer (April 23, 2021)
77 Keytruda for Breast Cancer (March 29, 2021)
78 Oral Paclitaxel for Breast Cancer (March 1, 2021)
79 Keytruda for Breast Cancer (February 9, 2021)
80 Keytruda for Breast Cancer (February 5, 2021)
82 KEY UPCOMING EVENTS
84 KEY OPINION LEADER INSIGHTS
85 UNMET NEEDS
86 BIBLIOGRAPHY
88 APPENDIX
LIST OF FIGURES
11 Figure 1: Triple-negative breast cancer patient segmentation
14 Figure 2: Recommended neoadjuvant/adjuvant chemotherapy regimens
18 Figure 3: Trends in incident cases of breast cancer, 2018–27
28 Figure 4: Overview of pipeline drugs for breast cancer in the US
28 Figure 5: Pipeline drugs for breast cancer, by company
29 Figure 6: Pipeline drugs for breast cancer, by drug type
29 Figure 7: Pipeline drugs for breast cancer, by classification
49 Figure 8: Probability of success in the breast cancer pipeline
53 Figure 9: Clinical trials in breast cancer
53 Figure 10: Top 10 drugs for clinical trials in breast cancer
54 Figure 11: Top 10 companies for clinical trials in breast cancer
54 Figure 12: Trial locations in breast cancer
55 Figure 13: Breast cancer trials status
56 Figure 14: Breast cancer trials sponsors, by phase
59 Figure 15: Datamonitor Healthcare’s drug assessment summary for triple-negative breast cancer
62 Figure 16: Market dynamics in triple-negative breast cancer
63 Figure 17: Future trends in triple-negative breast cancer
82 Figure 18: Key upcoming events in breast cancer (one of two)
83 Figure 19: Key upcoming events in breast cancer (two of two)
85 Figure 20: Unmet needs in triple-negative breast cancer
LIST OF TABLES
15 Table 1: Preferred branded treatment regimens for patients with Stage IV or recurrent triple-negative breast cancer
17 Table 2: Incident cases of breast cancer, 2018–27
19 Table 3: Five-year prevalent cases of breast cancer, 2018–27
20 Table 4: Breast cancer subtypes
22 Table 5: Marketed drugs for triple-negative breast cancer
30 Table 6: Pipeline drugs for triple-negative breast cancer in the US
66 Table 7: Historical global sales, by drug ($m), 2017–21
68 Table 8: Forecasted global sales, by drug ($m), 2022–26
70 Table 9: Enhertu for Breast Cancer (February 21, 2022)
71 Table 10: Veliparib for Breast Cancer (September 17, 2021)
72 Table 11: Multiple Drugs for Breast Cancer (June 5, 2021)
73 Table 12: Trodelvy for Breast Cancer (June 4, 2021)
74 Table 13: Keytruda for Breast Cancer (May 13, 2021)
75 Table 14: Tecentriq for Breast Cancer (April 27, 2021)
76 Table 15: Tecentriq for Breast Cancer (April 23, 2021)
77 Table 16: Keytruda for Breast Cancer (March 29, 2021)
78 Table 17: Oral Paclitaxel for Breast Cancer (March 1, 2021)
79 Table 18: Keytruda for Breast Cancer (February 9, 2021)
80 Table 19: Keytruda for Breast Cancer (February 5, 2021)
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