Disease Analysis: HR+/HER2- Breast Cancer
Author: Tara Hansen
Publisher: Datamonitor Healthcare
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Latest key takeaways
- Datamonitor Healthcare estimates that in 2018 there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide. By 2027, incident and prevalent cases of breast cancer are expected to increase to 2.3 million and 9.3 million cases, respectively.
- CDK4/6 inhibitors remain the standard treatment for advanced and metastatic HR+/HER2- patients. Datamonitor Healthcare expects their uptake to increase significantly over the forecast period as all three are projected to receive strategic label expansions into the adjuvant treatment setting for early-stage HR+/HER2- breast cancer patients.
- The PARP inhibitors have become the standard option for gBRCAm+ breast cancer patients. Despite their efficacy in this population, their overall commercial potential will remain limited by their positioning in this niche segment.
- Faslodex remains a key therapy across patient segments. Guideline recommendation for use at first-line and subsequent lines of therapy, indication for use in combination with the CDK4/6 inhibitors, as well as expansion as part of a combination with Piqray highlight its broad utility.
- Piqray is the first PI3K inhibitor approved for use in breast cancer. The overall potential of Piqray will be somewhat limited by its side-effect profile that includes high rates of neutropenia, nausea, hyperglycemia, and diarrhea.
- Afinitor remains a standard option for patients that progress on prior endocrine therapy, and is typically used post-CDK4/6 inhibitor treatment. However, generic versions of the drug will continue to take market share over the forecast period.
- Halaven’s overall potential will remain limited in this space as it is relegated to use as a salvage therapy in heavily pretreated patients and faces generic competition in all markets, beginning in 2023 in the US and 2024 in the EU and Japan.
- The utility of biomarker testing and its impact on subsequent treatment decisions in advanced and heavily pretreated patients is increasing and will continue to expand into earlier lines of therapy. Existing therapies like the PARP inhibitors and Piqray highlight this trend, and late-phase assets like PARP inhibitor veliparib and pan-Akt inhibitor ipatasertib will continue it in later portions of the forecast.
- All late-phase therapies in development for HR+/HER2- breast cancer are targeting advanced and heavily pretreated patients; potentially increasing competition and causing prescribing in advanced settings to become highly segmented.
- Generic and biosimilar versions of key branded therapies will slow growth of the HR+/HER2- breast cancer market. The largest generic impact will come from palbociclib generics, given that Ibrance is a standard therapy in treating HR+/HER2- breast cancer and physicians are expected to switch to cheaper generic versions of the molecule when they are expected to launch in 2023 in the US.
- A relatively high proportion of trials for breast cancer have been in Phase II (45.4%), compared to other indications. The US, France, and Spain have seen the greatest number of breast cancer trials, globally. Within Asia, China has the top spot. Clinical trial activity in the breast cancer space is dominated by completed trials. Roche has the highest number of completed clinical trials for breast cancer, with 441 trials.
- The overall likelihood of approval of a Phase I breast cancer asset is 8.8%, and the average probability a drug advances from Phase III is 60.0%. Breast cancer drugs, on average, take 9.8 years from Phase I to approval, compared to 9.2 years in the overall oncology space.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Risk factors
11 Symptoms
11 Diagnosis
11 Patient segmentation
12 Prognosis
13 TREATMENT
13 Referral patterns
13 Operable Stage I–III HR+/HER2- breast cancer
13 Inoperable Stage III HR+/HER2- breast cancer
14 Treatment guidelines for Stage IV or recurrent HR+/HER2- breast cancer
17 EPIDEMIOLOGY
17 Incidence and prevalence methodology
20 Breast cancer subtypes
22 MARKETED DRUGS
29 PIPELINE DRUGS
47 KEY REGULATORY EVENTS
47 India’s SPARC Keeps Paclitaxel Ambition Burning For Now
47 EU CDK 4/6 Inhibitor Safety Info Update Goes Ahead
47 EMA Monitors CDK 4/6 Inhibitors; US Issues Serious Side Effect Warning
47 Pfizer’s Ibrance And The Realities Of ‘Real-World’ Evidence
48 SMC Follows NICE And Backs Lilly’s Verzenios In Advanced Breast Cancer
48 Dual Approval For Verzenio Under International Review Scheme
49 PROBABILITY OF SUCCESS
50 LICENSING AND ASSET ACQUISITION DEALS
50 Tyligand Gets Onapristone ER Rights From Context
50 AZ Divests Arimidex And Casodex Rights To Juvisé
50 GSK’s Zejula Poised To Take On Lynparza In First-Line Ovarian Cancer
51 CLINICAL TRIAL LANDSCAPE
52 Sponsors by status
53 Sponsors by phase
54 Recent events
55 DRUG ASSESSMENT MODEL
58 MARKET DYNAMICS
59 FUTURE TRENDS
59 CDK4/6 inhibitors will remain the best-selling class for HR+/HER2- breast cancer
59 Treatment decisions will be increasingly informed by biomarker status
59 Treatment options in advanced patients will be increasingly segmented
60 Generic and biosimilar uptake will slow, but not reverse growth
61 CONSENSUS FORECASTS
64 RECENT EVENTS AND ANALYST OPINION
64 Onzeald for Breast Cancer (February 27, 2020)
64 Oraxol for Breast Cancer (December 13, 2019)
66 MCLA-128 for Breast Cancer (October 23, 2019)
67 Kisqali for Breast Cancer (September 29, 2019)
67 Rintodestrant for Breast Cancer (September 29, 2019)
69 Verzenio for Breast Cancer (September 29, 2019)
71 Oraxol for Breast Cancer (August 7, 2019)
73 Verzenio for Breast Cancer (July 30, 2019)
74 MGA012 for Breast Cancer (July 2, 2019)
75 Multiple Drugs for Breast Cancer (June 25, 2019)
76 Capivasertib for Breast Cancer (June 4, 2019)
77 Talzenna for Breast Cancer (June 3, 2019)
78 H3B-6545 for Breast Cancer (June 2, 2019)
80 Kisqali for Breast Cancer (June 1, 2019)
82 therascreen PIK3CA RGQ PCR Kit for Breast Cancer (May 24, 2019)
83 Trodelvy for Breast Cancer (April 29, 2019)
85 KEY UPCOMING EVENTS
87 KEY OPINION LEADER INSIGHTS
88 BIBLIOGRAPHY
89 Prescription information
90 APPENDIX
LIST OF FIGURES
12 Figure 1: Patient segmentation
14 Figure 2: Recommended adjuvant endocrine therapy regimens for HR+/HER2- breast cancer
19 Figure 3: Trends in incident cases of breast cancer, 2018–27
29 Figure 4: Overview of pipeline drugs for breast cancer in the US
29 Figure 5: Pipeline drugs for breast cancer, by company
30 Figure 6: Pipeline drugs for breast cancer, by drug type
30 Figure 7: Pipeline drugs for breast cancer, by classification
49 Figure 8: Probability of success in the breast cancer pipeline
51 Figure 9: Clinical trials in breast cancer
51 Figure 10: Top 10 drugs for clinical trials in breast cancer
52 Figure 11: Top 10 companies for clinical trials in breast cancer
52 Figure 12: Trial locations in breast cancer
53 Figure 13: Breast cancer trials status
54 Figure 14: Breast cancer trials sponsors, by phase
55 Figure 15: Datamonitor Healthcare’s drug assessment summary for HR+/HER2- breast cancer
58 Figure 16: Market dynamics in HR+/HER2- breast cancer
59 Figure 17: Future trends in HR+/HER2- breast cancer
69 Figure 18: Rintodestrant for Breast Cancer (September 29, 2019): Phase I/IIa – G1T48-01
71 Figure 19: Verzenio for Breast Cancer (September 29, 2019): Phase III – MONARCH 2 (w/Fulvestrant, HR+/HER2-)
73 Figure 20: Oraxol for Breast Cancer (August 7, 2019): Phase III – KX-ORAX-001 (S. America)
74 Figure 21: Verzenio for Breast Cancer (July 30, 2019): Phase III – MONARCH 2 (w/Fulvestrant, HR+/HER2-)
77 Figure 22: Capivasertib for Breast Cancer (June 4, 2019): Phase Ib/II – FAKTION
80 Figure 23: H3B-6545 for Breast Cancer (June 2, 2019): Phase I/II – Monotherapy (HER2 Negative Subjects)
82 Figure 24: Kisqali for Breast Cancer (June 1, 2019): Phase III – MONALEESA-7 (Premenopausal, HER2-)
85 Figure 25: Key upcoming events in breast cancer
86 Figure 26: Key upcoming events in breast cancer (continued)
LIST OF TABLES
15 Table 1: Branded treatment regimens for patients with Stage IV or recurrent HR+/HER2- breast cancer
18 Table 2: Incident cases of breast cancer, 2018–27
20 Table 3: Five-year prevalent cases of breast cancer, 2018–27
21 Table 4: Breast cancer subtypes
23 Table 5: Marketed drugs for HR+/HER2- breast cancer
31 Table 6: Pipeline drugs for HR+/HER2- breast cancer in the US
62 Table 7: Historical global sales, by drug ($m), 2015–19
63 Table 8: Forecasted global sales, by drug ($m), 2020–24
64 Table 9: Onzeald for Breast Cancer (February 27, 2020)
65 Table 10: Oraxol for Breast Cancer (December 13, 2019)
66 Table 11: MCLA-128 for Breast Cancer (October 23, 2019)
67 Table 12: Kisqali for Breast Cancer (September 29, 2019)
68 Table 13: Rintodestrant for Breast Cancer (September 29, 2019)
70 Table 14: Verzenio for Breast Cancer (September 29, 2019)
72 Table 15: Oraxol for Breast Cancer (August 7, 2019)
73 Table 16: Verzenio for Breast Cancer (July 30, 2019)
74 Table 17: MGA012 for Breast Cancer (July 2, 2019)
75 Table 18: Multiple Drugs for Breast Cancer (June 25, 2019)
76 Table 19: Capivasertib for Breast Cancer (June 4, 2019)
78 Table 20: Talzenna for Breast Cancer (June 3, 2019)
79 Table 21: H3B-6545 for Breast Cancer (June 2, 2019)
81 Table 22: Kisqali for Breast Cancer (June 1, 2019)
82 Table 23: therascreen PIK3CA RGQ PCR Kit for Breast Cancer (May 24, 2019)
84 Table 24: Trodelvy for Breast Cancer (April 29, 2019)
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