Human epidermal growth factor 2-positive (HER2+) breast cancer is characterized by amplification of the HER2/neu oncogene. 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 HER2+ breast cancer market will grow between 2021 and 2025, with rising sales in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK); however, the market will experience a slight downturn after 2025 as key brands Perjeta and Kadcyla face biosimilar erosion across all regions. Furthermore, the market for HER2+ breast cancer is also becoming increasingly crowded, creating fierce competition among approved and pipeline therapies.
High prices for combination regimens will translate to high revenues, despite the introduction of biosimilars. The increased use of combination regimens, in conjunction with the continued uptake of novel branded therapies and rising disease prevalence, will partially offset the decrease in revenues caused by biosimilars over the forecast period.
Herceptin is the current standard-of-care therapy, and is used in every line of treatment, primarily as part of a combination regimen. However, it has steadily lost market share following the introduction of trastuzumab biosimilars in 2019.
Despite initially encountering reimbursement challenges, Perjeta in combination with Herceptin has become the standard of care for both neoadjuvant and first-line treatment of HER2+ breast cancer after demonstrating an overall survival benefit in the Phase III CLEOPATRA and APHINITY studies. Additionally, Roche recently launched Phesgo, a subcutaneous formulation of the combination.
Since its approval in 2013, Kadcyla has become the standard of care both for HER2+ breast cancer patients who have residual invasive disease after neoadjuvant taxane- and Herceptin-based treatment, and for patients with metastatic disease who have progressed on a trastuzumab-containing regimen.
Nerlynx, which is approved for the extended adjuvant setting, has experienced limited commercial success due to a lack of an overall survival benefit, high rates of diarrhea, and a high price. Although Puma Biotechnology is positioning Nerlynx as a third-line treatment, the drug may struggle to gain market share in the increasingly crowded third-line market.
Tykerb's unfavorable clinical results and the success of Kadcyla in later lines of therapy have limited the tyrosine kinase inhibitor's commercial potential. The introduction of Enhertu and other expected third-line treatments will further limit Tykerb's future commercial potential.
Enhertu received approval as a third-line treatment for locally advanced or metastatic patients after demonstrating strong efficacy results in the pivotal Phase II DESTINY-Breast01 study. Enhertu is currently being tested against investigator's choice of treatment in the confirmatory Phase III DESTINY-Breast02 study. Daiichi Sankyo and AstraZeneca are also testing Enhertu in the Phase III DESTINY-Breast03, DESTINY-Breast05, and DESTINY-Breast09 studies, which could support label expansions for Enhertu in multiple treatment settings.
Tukysa, which was recently approved in the US and Europe, is becoming the treatment of choice in third-line patients with brain metastases after demonstrating positive efficacy results in the pivotal Phase II HER2CLIMB study. Although Tukysa's overall commercial potential is currently somewhat limited by the small size of the heavily pretreated patient population with brain metastases, Seagen recently initiated the Phase III CompassHER2 RD trial testing Tukysa in combination with Kadcyla in the high-risk adjuvant setting in an attempt to broaden Tukysa's potential patient population.
Margenza was recently approved in the US for the third-line setting, but has a limited commercial outlook given it will face significant competition from both approved and late-phase competitors in an increasingly crowded market. Although Margenza demonstrated a progression-free survival benefit and a trend toward an overall survival benefit in the Phase III SOPHIA study, both Tukysa and Enhertu have shown better efficacy results.
Key recent events include the US launch of Margenza in the third-line setting, as well as European approvals for Tukysa, Phesgo, and Enhertu.
Key upcoming catalysts in 2021 include topline results from the registrational Phase III TULIP study of (vic-)trastuzumab duocarmazine, and topline results from the Phase III DESTINY-Breast03 trial of Enhertu.
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.
Key Topics Covered:
Latest key takeaways
Determination of HER2 status
Operable Stage I-III HER2+ breast cancer
Inoperable Stage III HER2+ breast cancer
Neoadjuvant/adjuvant therapy regimens
Treatment guidelines for Stage IV or recurrent HER2+ breast cancer
Breast cancer subtypes
KEY REGULATORY EVENTS
NICE Funding Wins For Enhertu & Kesimpta Are Firsts For England
Seagen Debuts In EU With Tukysa Launch & Sees UK As 'Key' Future Market
Setback For Athenex, Hanmi As CRL Requests New Trial
Enhertu Nabs A First With UK Standalone Approval
Roche's Phesgo Could Reduce Healthcare Costs In EU
MacroGenics Gets Nod For Margenza In HER2-Positive Breast Cancer
Early EU Approval Wins In Line For Daiichi/AZ & Lilly
Phesgo & Roclanda Among New Winners At EMA
Scottish HTA OKs Neratinib For Early-Stage Breast Cancer
Updated: Multiple Biosimilars To Avastin Have Launched In EU
Latest EU Filings Include AstraZeneca/Daiichi Sankyo's Enhertu
Genentech Wins FDA Approval For Phesgo
Accord Backed In EU For Trastuzumab And Apixaban
England's NICE Says Yes To Kadcyla In Early Breast Cancer
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
Twice As Nice: Seattle Genetics, Merck & Co Partner On Two Cancer Drugs
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
DRUG ASSESSMENT MODEL
Launches of new targeted therapies and label expansions will partially counteract biosimilar-led market decline later in the forecast period
Pipeline drugs will face strong competition in a saturated market
Uptake of combination regimens will drive high revenues
Trastuzumab biosimilars will have a minor impact on the overall market
RECENT EVENTS AND ANALYST OPINION
Oral Paclitaxel for Breast Cancer (March 1, 2021)
Oral Paclitaxel for Breast Cancer (December 9, 2020)
Poziotinib for Breast Cancer (December 9, 2020)
Tukysa for Breast Cancer (May 29, 2020)
Kadcyla for Breast Cancer (May 13, 2020)
KEY UPCOMING EVENTS
KEY OPINION LEADER INSIGHTS
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Laura Wood, Senior Press Manager
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