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Disease Analysis: Triple-Negative Breast Cancer

  • ID: 4997162
  • Report
  • May 2021
  • Region: Global
  • 97 Pages
  • Pharma Intelligence
Latest Key Takeaways

  • Triple-negative breast cancer (TNBC) is characterized by the absence of estrogen and progesterone receptors, and does not involve the overexpression of human epidermal growth factor 2 (HER2). 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 five-year prevalent cases of breast cancer are expected to increase to 2.3 million and 9.3 million cases, respectively.
  • The TNBC market will experience rapid growth over the next 10 years across the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK). The primary drivers for this growth are the approval and subsequent uptake of new targeted therapies and immunotherapies. The market for TNBC is also becoming increasingly segmented by biomarker status, creating fierce competition among both approved and pipeline therapies for small patient populations.
  • There will likely be reimbursement issues as payers may initially hesitate to reimburse new treatments based on novel biomarkers. Additionally, payers may be unwilling to reimburse expensive therapies with only incremental improvements in patient outcomes.
  • Avastin’s relatively poor risk-to-benefit profile has led to removal from the US market and difficulties with reimbursement in the UK, where it was also removed from the Cancer Drugs Fund. Additionally, Avastin faces biosimilar competition following its 2019 patent expiry.
  • Abraxane is a preferred treatment regimen in cases of hypersensitivity to paclitaxel, and has demonstrated efficacy as a first- and second-line monotherapy treatment. The recent approval in combination with Tecentriq has boosted Abraxane’s clinical and commercial potential, although it is forecast to steadily lose market share after the introduction of generics in the EU in 2019 and in the US in 2022.
  • Programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1)-targeted monoclonal antibodies for TNBC are forecast to become the best-selling class of drugs for this indication. Tecentriq in combination with Abraxane was the first immunotherapy approved for TNBC patients in the first-line setting, and Roche and Chugai are pursuing label expansions for Tecentriq in both the neoadjuvant and adjuvant settings. Although Tecentriq’s accelerated approval was in danger following the failure of the Phase III IMpassion131 trial, the FDA Oncologic Drugs Advisory Committee recently voted to maintain Tecentriq’s accelerated approval in the first-line setting pending data from the Phase III IMpassion132 trial. However, competitor Keytruda is expected to overtake Tecentriq in the first-line setting due to its wide variety of chemotherapy backbone options. After the Oncologic Drugs Advisory Committee unanimously voted to delay an approval decision pending more mature event-free survival data from the Phase III KEYNOTE-522 trial, Keytruda’s possible entry into the lucrative neoadjuvant/adjuvant market has been significantly delayed.
  • Although approved PARP inhibitors Lynparza and Talzenna are restricted to the relatively small germline BRCA1/2-mutated (gBRCAm) population, they are forecast to dominate within this patient segment. An expected label expansion into the adjuvant treatment setting for gBRCAm patients will add to Lynparza’s sales, making it one of the best-selling TNBC therapies over the next 10 years.
  • Halaven has become a standard of care for third-line and later treatment of TNBC since its approval, despite encountering challenges with reimbursement. Additionally, Halaven’s market share may increase with a potential label for use with the chemokine (C-X-C motif) receptor 4 (CXCR4) inhibitor balixafortide. The combination has received Fast Track status after showing promising early efficacy results in a Phase Ib study. The commercial potential of this combination will help to offset the decline in Halaven’s revenues caused by competition from a number of recently approved and current pipeline drugs.
  • In early 2020, Trodelvy received accelerated approval in the US for the treatment of TNBC patients who have failed at least two prior therapies, based on positive efficacy results in a Phase I/II study. Given the high unmet need and poor prognosis in this line of treatment, Trodelvy has experienced remarkably quick uptake after its launch despite the inclusion of two black box warnings on its label. The confirmatory Phase III ASCENT study was recently halted early due to evidence of strong efficacy, and the FDA granted full approval to Trodelvy in April 2021.
  • Capivasertib and Piqray are both in development in the front-line setting for the 25-30% of patients who present with phosphatase and tensin homolog (PTEN)/phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)/protein kinase B alpha (Akt)-altered tumors. While these novel therapies will dominate within patients in this subgroup, their overall commercial potential is limited due to the biomarker restriction. Capivasertib will likely be the first Akt inhibitor to market after late-phase competitor ipatasertib failed in the Phase III IPATunity130 trial and Roche’s subsequent decision to discontinue the Phase III IPATunity170 trial.
  • Key recent events include the FDA Oncologic Drugs Advisory Committee meeting for Keytruda’s supplemental Biologics License Application in the neoadjuvant/adjuvant setting, as well as the meeting re-examining Tecentriq’s accelerated approval in the first-line setting.
  • Key upcoming catalysts for 2021 include topline read-outs from the Phase III FORTRESS study of balixafortide and Halaven and from the Phase III OlympiA study of Lynparza.
  • 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.
Note: Product cover images may vary from those shown

OVERVIEW
  • Latest key takeaways

DISEASE BACKGROUND
  • Definition
  • Risk factors
  • Symptoms
  • Diagnosis
  • Patient segmentation
  • Prognosis

TREATMENT
  • Referral patterns
  • Operable Stage I–III TNBC
  • Inoperable Stage III TNBC
  • Recommended neoadjuvant/adjuvant chemotherapy regimens
  • Treatment guidelines for Stage IV or recurrent TNBC

EPIDEMIOLOGY
  • Breast cancer subtypes

MARKETED DRUGSPIPELINE DRUGS
KEY REGULATORY EVENTS
  • Genentech’s Tecentriq Should Keep Its Accelerated Approval In Breast Cancer For Now, ODAC Says
  • Genentech’s Hopes For Keeping Tecentriq Breast Cancer Claim May Rest With Trial In Early Disease Recurrence
  • Gilead’s Trodelvy Gets Full Approval For TNBC
  • Gilead’s Trodelvy To Test UK Innovative Drug Pathway
  • Gilead Sciences/Immunomedics Seek EU Fast-Track For Sacituzumab Govitecan
  • Setback For Athenex, Hanmi As CRL Requests New Trial
  • Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
  • Keytruda Takes On Tecentriq In TNBC Market
  • Centus Gets European Bevacizumab Approval
  • Samsung Bioepis Receives EU Bevacizumab Approval
  • Updated: Multiple Biosimilars To Avastin Have Launched In EU
  • Samsung Bioepis Bevacizumab Nod Sets Stage For EU Throwdown
  • Triple-Negative Breast Cancer First In England As NICE Reverses Tecentriq Rejection

PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • SELLAS Licenses Greater China Rights For Immunotherapies To 3D
  • Boehringer Buys Antibody-Drug Conjugates Biotech NBE For €1.18bn
  • Twice As Nice: Seattle Genetics, Merck & Co. Partner On Two Cancer Drugs
  • Gilead Buys Pipeline-In-A-Product With $21bn Immunomedics Deal
  • TriSalus Buys Dynavax’s Melanoma/Breast Cancer Therapy
  • AZ Bets Big On ADCs As It Inks Second, $6bn Deal With Daiichi
  • 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 MODELMARKET DYNAMICS
FUTURE TRENDS
  • Approvals and subsequent uptake for new targeted therapies and immunotherapies will drive growth in the TNBC market
  • over the forecast period
  • Keytruda will overtake Tecentriq in the TNBC market during the forecast period
  • The PARP inhibitors will see significant use in the subset of TNBC patients with BRCA mutations over the forecast period
  • ADCs will dominate in the second-line and later setting over the forecast period

CONSENSUS FORECASTS
RECENT EVENTS AND ANALYST OPINION
  • Tecentriq for Breast Cancer (April 27, 2021)
  • Tecentriq for Breast Cancer (April 23, 2021)
  • Keytruda for Breast Cancer (March 29, 2021)
  • Oral Paclitaxel for Breast Cancer (March 1, 2021)
  • Keytruda for Breast Cancer (February 9, 2021)
  • Keytruda for Breast Cancer (February 5, 2021)
  • Eganelisib for Breast Cancer (December 9, 2020)
  • Oral Paclitaxel for Breast Cancer (December 9, 2020)
  • Ipatasertib for Breast Cancer (September 30, 2020)
  • Tecentriq for Breast Cancer (September 19, 2020)
  • Tecentriq for Breast Cancer (September 19, 2020)
  • Trodelvy for Breast Cancer (September 19, 2020)
  • Tecentriq for Breast Cancer (August 6, 2020)
  • Trodelvy for Breast Cancer (July 6, 2020)
  • Tecentriq for Breast Cancer (June 18, 2020)
  • Keytruda for Breast Cancer (May 13, 2020)

KEY UPCOMING EVENTSKEY OPINION LEADER INSIGHTSUNMET NEEDSBIBLIOGRAPHYAPPENDIX
LIST OF FIGURES
Figure 1: Triple-negative breast cancer patient segmentation
Figure 2: Recommended neoadjuvant/adjuvant chemotherapy regimens
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 triple-negative breast cancer
Figure 16: Market dynamics in triple-negative breast cancer
Figure 17: Future trends in triple-negative breast cancer
Figure 18: Eganelisib for Breast Cancer (December 9, 2020): Phase II - MARIO-3
Figure 19: Oral Paclitaxel for Breast Cancer (December 9, 2020): Phase III - KX-ORAX-001 (S. America)
Figure 20: Ipatasertib for Breast Cancer (September 30, 2020): Phase III - IPATunity130
Figure 21: Tecentriq for Breast Cancer (September 19, 2020): Phase III - IMpassion 130 (w/Nab-Paclitaxel), Phase III - IMpassion131 (w/Paclitaxel, 1st-Line)
Figure 22: Tecentriq for Breast Cancer (September 19, 2020): Phase III - IMpassion031 (w/Nab-Paclitaxel)
Figure 23: Trodelvy for Breast Cancer (September 19, 2020): Phase III - ASCENT (TNBC)
Figure 24: Tecentriq for Breast Cancer (August 6, 2020): Phase III - IMpassion131 (w/Paclitaxel, 1st-Line)
Figure 25: Trodelvy for Breast Cancer (July 6, 2020): Phase III - ASCENT (TNBC)
Figure 26: Keytruda for Breast Cancer (May 13, 2020): Phase III - KEYNOTE-355 (TNBC)
Figure 27: Key upcoming events in breast cancer
Figure 28: Unmet needs in triple-negative breast cancer
LIST OF TABLES
Table 1: Preferred branded treatment regimens for patients with Stage IV or recurrent triple-negative 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 triple-negative breast cancer
Table 6: Pipeline drugs for triple-negative 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: Tecentriq for Breast Cancer (April 27, 2021)
Table 10: Tecentriq for Breast Cancer (April 23, 2021)
Table 11: Keytruda for Breast Cancer (March 29, 2021)
Table 12: Oral Paclitaxel for Breast Cancer (March 1, 2021)
Table 13: Keytruda for Breast Cancer (February 9, 2021)
Table 14: Keytruda for Breast Cancer (February 5, 2021)
Table 15: Eganelisib for Breast Cancer (December 9, 2020)
Table 16: Oral Paclitaxel for Breast Cancer (December 9, 2020)
Table 17: Ipatasertib for Breast Cancer (September 30, 2020)
Table 18: Tecentriq for Breast Cancer (September 19, 2020)
Table 19: Tecentriq for Breast Cancer (September 19, 2020)
Table 20: Trodelvy for Breast Cancer (September 19, 2020)
Table 21: Tecentriq for Breast Cancer (August 6, 2020)
Table 22: Trodelvy for Breast Cancer (July 6, 2020)
Table 23: Tecentriq for Breast Cancer (June 18, 2020)
Table 24: Keytruda for Breast Cancer (May 13, 2020)
Note: Product cover images may vary from those shown