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Disease Analysis: HR+/HER2- Breast Cancer

  • ID: 4997159
  • Report
  • May 2021
  • Region: Global
  • 97 pages
  • Datamonitor Healthcare
Definition

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. 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
  • The publisher 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. The publisher 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. Verzenio is set to be the first of these therapies approved in early breast cancer, with US and EU regulatory decisions expected towards the end of 2021. Submissions were based on positive results from the Phase III monarchE trial. 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 inavolisib.
  • Afinitor remains a standard option for patients who 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 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 impact will come from palbociclib generics, although their launch is now delayed until at least 2027 following the extension of Ibrance’s key ‘739 patent.
  • Key upcoming events include the final OS analysis for eftilagimod alpha in the Phase IIb AIPAC trial, topline results for Trodelvy in the Phase III TROPICS-02 study, first results from elacestrant in the Phase III EMERALD study, as well as a CHMP opinion and EU and US supplementary approval decisions for Verzenio in high-risk, early-stage HR+/HER2- breast cancer patients.
  • A relatively high proportion of trials for breast cancer have been in Phase II (44.9%), 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 465 trials.
  • The overall likelihood of approval of a Phase I breast cancer asset is 7.8%, and the average probability a drug advances from Phase III is 57.1%. Breast cancer drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
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OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Risk factors
  • Symptoms
  • Diagnosis
  • Patient segmentation
  • Prognosis
TREATMENT
  • Referral patterns
  • Operable Stage I–III HR+/HER2- breast cancer
  • Inoperable Stage III HR+/HER2- breast cancer
  • Treatment guidelines for Stage IV or recurrent HR+/HER2- breast cancer
EPIDEMIOLOGY
  • Incidence and prevalence methodology
  • Breast cancer subtypes
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Setback For Athenex, Hanmi As CRL Requests New Trial
  • New Evidence For Kisqali Secures Funding In England For Second-Line Use
  • Lilly Undeterred By UK NICE Funding Blow For Second-Line Use Of Verzenios
  • Generic Ibrance Among Latest China Approvals
  • EU Decision Thwarts Novartis’s Near-Term Piqray Ambitions
  • EU Indication Restricted For Novartis's Newly Approved Piqray
  • EU Approval Nod Possible For Novartis, Gilead/Galapagos, and Janssen
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Celcuity Licenses Breast Cancer Clinical Candidate From Pfizer
  • SELLAS Licenses Greater China Rights For Immunotherapies To 3D
  • Merck Pays $2.75bn To Access VelosBio’s ROR1-Targeting ADCs
  • Bayer Licenses ER+ Breast Cancer Candidate From Systems Biology
  • Twice As Nice: Seattle Genetics, Merck & Co. Partner On Two Cancer Drugs
  • TriSalus Buys Dynavax’s Melanoma/Breast Cancer Therapy
  • Menarini Expands In Cancer With Radius Drug Deal
  • Daiichi Sankyo Partners With Syneos Health For Development Of Enhertu And Other Cancer Drugs
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS
  • CDK4/6 inhibitors will remain the best-selling class for HR+/HER2- breast cancer
  • Treatment decisions will be increasingly informed by biomarker status
  • Treatment options in advanced patients will be increasingly segmented
  • Generic and biosimilar uptake will slow, but not reverse, growth
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Oral Paclitaxel for Breast Cancer (March 1, 2021)
  • ARV-471 for Breast Cancer (December 14, 2020)
  • Tesetaxel for Breast Cancer (December 11, 2020)
  • Oral Paclitaxel for Breast Cancer (December 9, 2020)
  • Ibrance for Breast Cancer (October 9, 2020)
  • Ibrance for Breast Cancer (September 20, 2020)
  • Verzenio for Breast Cancer (September 20, 2020)
  • Ipatasertib for Breast Cancer (September 18, 2020)
  • Tesetaxel for Breast Cancer (August 24, 2020)
  • AZD9833 for Breast Cancer (May 29, 2020)
  • Ibrance for Breast Cancer (May 29, 2020)
  • Entinostat for Breast Cancer (May 21, 2020)
  • Endoxifen for Breast Cancer (May 7, 2020)
KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES
Figure 1: TNM staging system for breast cancer
Figure 2: Recommended adjuvant endocrine therapy regimens for HR+/HER2- breast cancer
Figure 3: Trends in incident cases of breast cancer, 2018–27
Figure 4: Overview of pipeline drugs for breast cancer in the US
Figure 5: Pipeline drugs for breast cancer, by company
Figure 6: Pipeline drugs for breast cancer, by drug type
Figure 7: Pipeline drugs for breast cancer, by classification
Figure 8: Probability of success in the breast cancer pipeline
Figure 9: Clinical trials in breast cancer
Figure 10: Top 10 drugs for clinical trials in breast cancer
Figure 11: Top 10 companies for clinical trials in breast cancer
Figure 12: Trial locations in breast cancer
Figure 13: Breast cancer trials status
Figure 14: Breast cancer trials sponsors, by phase
Figure 15: The publisher’s drug assessment summary for HR+/HER2- breast cancer
Figure 16: Market dynamics in HR+/HER2- breast cancer
Figure 17: Future trends in HR+/HER2- breast cancer
Figure 18: Tesetaxel for Breast Cancer (December 11, 2020): Phase III - CONTESSA (HER2-/HR+/Prev. Taxane)
Figure 19: Oral Paclitaxel for Breast Cancer (December 9, 2020): Phase III - KX-ORAX-001 (S. America)
Figure 20: Verzenio for Breast Cancer (September 20, 2020): Phase III - monarchE
Figure 21: Ipatasertib for Breast Cancer (September 18, 2020): Phase III - IPATunity130
Figure 22: Tesetaxel for Breast Cancer (August 24, 2020): Phase III - CONTESSA (HER2-/HR+/Prev. Taxane)
Figure 23: AZD9833 for Breast Cancer (May 29, 2020): Phase I - SERENA-1
Figure 24: Entinostat for Breast Cancer (May 21, 2020): Phase III - w/Exemestane (ER+/HER2-, NCI)
Figure 25: Key upcoming events in breast cancer
Figure 26: Key upcoming events in breast cancer (continued)

LIST OF TABLES
Table 1: Branded treatment regimens for patients with Stage IV or recurrent HR+/HER2- breast cancer
Table 2: Incident cases of breast cancer, 2018–27
Table 3: Five-year prevalent cases of breast cancer, 2018–27
Table 4: Breast cancer subtypes
Table 5: Marketed drugs for HR+/HER2- breast cancer
Table 6: Pipeline drugs for HR+/HER2- breast cancer in the US
Table 7: Historical global sales, by drug ($m), 2016–20
Table 8: Forecasted global sales, by drug ($m), 2021–25
Table 9: Oral Paclitaxel for Breast Cancer (March 1, 2021)
Table 10: ARV-471 for Breast Cancer (December 14, 2020)
Table 11: Tesetaxel for Breast Cancer (December 11, 2020)
Table 12: Oral Paclitaxel for Breast Cancer (December 9, 2020)
Table 13: Ibrance for Breast Cancer (October 9, 2020)
Table 14: Ibrance for Breast Cancer (September 20, 2020)
Table 15: Verzenio for Breast Cancer (September 20, 2020)
Table 16: Ipatasertib for Breast Cancer (September 18, 2020)
Table 17: Tesetaxel for Breast Cancer (August 24, 2020)
Table 18: AZD9833 for Breast Cancer (May 29, 2020)
Table 19: Ibrance for Breast Cancer (May 29, 2020)
Table 20: Entinostat for Breast Cancer (May 21, 2020)
Table 21: Endoxifen for Breast Cancer (May 7, 2020)
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