Disease Analysis: HR+/HER2- Breast Cancer
Author: Zachary McLellan
Publisher: Datamonitor Healthcare
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Overview
Hormone receptor-positive (HR+) is the most common breast cancer subtype, with approximately 70% of breast cancers presenting with overexpression of estrogen receptors, progesterone receptors, or both (De Placido and Pronzato, 2015). Overexpression of the hormone receptors allows estrogen and progesterone to drive tumor growth and proliferation. Therefore, endocrine therapy remains the standard treatment for advanced patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
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 Verzenio and Kisqali are projected to receive strategic label expansions into the adjuvant treatment setting for early-stage HR+/HER2- breast cancer patients. Ibrance is not forecasted to receive a similar approval after the failure of the PALLAS and PENELOPE-B trials.
- 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 in the near term by their positioning in this niche segment. Expansion into the adjuvant setting for earlier-stage disease will improve their outlook in the latter years of the forecast period.
- Fulvestrant remains a key therapy across patient segments. Guideline recommendations for use at first line and subsequent lines of therapy, an 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. However, generic competition will continue to erode branded Faslodex’s market share.
- 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. It also faces potential intra-class competition from late-phase PI3K/Akt/mTOR pathway inhibitors ipatasertib, capivasertib, and RG6114.
- 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.
- 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. Late-phase assets such as PARP inhibitor veliparib, pan-Akt inhibitor ipatasertib, and PI3K-alpha inhibitor capivasertib will continue the trend in later portions of the forecast period.
- The majority of 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 set 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 (45.3%), compared to other indications. The US, Spain, and France 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 456 trials.
- The overall likelihood of approval of a Phase I breast cancer asset is 8.4%, and the average probability a drug advances from Phase III is 58.2%. Breast cancer drugs, on average, take 9.7 years from Phase I to approval, compared to 9.5 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
49 KEY REGULATORY EVENTS
49 EU Decision Thwarts Novartis’s Near-Term Piqray Ambitions
49 EU Indication Restricted For Novartis’s Newly Approved Piqray
49 EU Approval Nod Possible For Novartis, Gilead/Galapagos, and Janssen
49 EU CDK 4/6 Inhibitor Safety Info Update Goes Ahead
51 PROBABILITY OF SUCCESS
52 LICENSING AND ASSET ACQUISITION DEALS
52 Merck Pays $2.75bn To Access VelosBio’s ROR1-Targeting ADCs
52 Bayer Licenses ER+ Breast Cancer Candidate From Systems Biology
52 Twice As Nice: Seattle Genetics, Merck & Co. Partner On Two Cancer Drugs
53 TriSalus Buys Dynavax’s Melanoma/Breast Cancer Therapy
53 Menarini Expands In Cancer With Radius Drug Deal
53 Daiichi Sankyo Partners With Syneos Health For Development Of Enhertu And Other Cancer Drugs
53 Tyligand Gets Onapristone ER Rights From Context
53 AZ Divests Arimidex And Casodex Rights To Juvisé
55 CLINICAL TRIAL LANDSCAPE
56 Sponsors by status
57 Sponsors by phase
58 Recent events
61 DRUG ASSESSMENT MODEL
65 MARKET DYNAMICS
66 FUTURE TRENDS
66 CDK4/6 inhibitors will remain the best-selling class for HR+/HER2- breast cancer
66 Treatment decisions will be increasingly informed by biomarker status
66 Treatment options in advanced patients will be increasingly segmented
67 Generic and biosimilar uptake will slow, but not reverse, growth
68 CONSENSUS FORECASTS
72 RECENT EVENTS AND ANALYST OPINION
72 Ibrance for Breast Cancer (October 9, 2020)
73 Ibrance for Breast Cancer (September 20, 2020)
73 Verzenio for Breast Cancer (September 20, 2020)
75 Ipatasertib for Breast Cancer (September 18, 2020)
77 Tesetaxel for Breast Cancer (August 24, 2020)
79 AZD9833 for Breast Cancer (May 29, 2020)
80 Ibrance for Breast Cancer (May 29, 2020)
81 Entinostat for Breast Cancer (May 21, 2020)
83 Endoxifen for Breast Cancer (May 7, 2020)
84 Onzeald for Breast Cancer (February 27, 2020)
85 Oral Paclitaxel for Breast Cancer (December 13, 2019)
87 KEY UPCOMING EVENTS
89 KEY OPINION LEADER INSIGHTS
90 BIBLIOGRAPHY
91 Prescription information
92 APPENDIX
LIST OF FIGURES
12 Figure 1: TNM staging system for breast cancer
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
30 Figure 5: Pipeline drugs for breast cancer, by company
30 Figure 6: Pipeline drugs for breast cancer, by drug type
31 Figure 7: Pipeline drugs for breast cancer, by classification
51 Figure 8: Probability of success in the breast cancer pipeline
55 Figure 9: Clinical trials in breast cancer
55 Figure 10: Top 10 drugs for clinical trials in breast cancer
56 Figure 11: Top 10 companies for clinical trials in breast cancer
56 Figure 12: Trial locations in breast cancer
57 Figure 13: Breast cancer trials status
58 Figure 14: Breast cancer trials sponsors, by phase
61 Figure 15: Datamonitor Healthcare’s drug assessment summary for HR+/HER2- breast cancer
65 Figure 16: Market dynamics in HR+/HER2- breast cancer
66 Figure 17: Future trends in HR+/HER2- breast cancer
75 Figure 18: Verzenio for Breast Cancer (September 20, 2020): Phase III – monarchE
77 Figure 19: Ipatasertib for Breast Cancer (September 18, 2020): Phase III – IPATunity130
79 Figure 20: Tesetaxel for Breast Cancer (August 24, 2020): Phase III – CONTESSA (HER2-/HR+/Prev. Taxane)
80 Figure 21: AZD9833 for Breast Cancer (May 29, 2020): Phase I – SERENA-1
83 Figure 22: Entinostat for Breast Cancer (May 21, 2020): Phase III – w/Exemestane (ER+/HER2-, NCI)
87 Figure 23: Key upcoming events in breast cancer
88 Figure 24: 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
32 Table 6: Pipeline drugs for HR+/HER2- breast cancer in the US
69 Table 7: Historical global sales, by drug ($m), 2015–19
71 Table 8: Forecasted global sales, by drug ($m), 2020–24
72 Table 9: Ibrance for Breast Cancer (October 9, 2020)
73 Table 10: Ibrance for Breast Cancer (September 20, 2020)
74 Table 11: Verzenio for Breast Cancer (September 20, 2020)
76 Table 12: Ipatasertib for Breast Cancer (September 18, 2020)
78 Table 13: Tesetaxel for Breast Cancer (August 24, 2020)
79 Table 14: AZD9833 for Breast Cancer (May 29, 2020)
81 Table 15: Ibrance for Breast Cancer (May 29, 2020)
82 Table 16: Entinostat for Breast Cancer (May 21, 2020)
83 Table 17: Endoxifen for Breast Cancer (May 7, 2020)
84 Table 18: Onzeald for Breast Cancer (February 27, 2020)
85 Table 19: Oral Paclitaxel for Breast Cancer (December 13, 2019)
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