Market Research Report
Disease Analysis: Triple-Negative Breast Cancer
|Published by||Datamonitor Healthcare||Product code||927047|
|Published||Content info||88 Pages
Delivery time: 1-2 business days
|Disease Analysis: Triple-Negative Breast Cancer|
|Published: September 15, 2020||Content info: 88 Pages||
TNBC is a relatively rare breast cancer subtype. It is characterized by the absence of estrogen and progesterone receptors, and does not involve the overexpression of HER2. TNBC is associated with poor prognosis, a high risk of local recurrence, and poor disease-free and cancer-specific survival. It accounts for roughly 14% of breast cancers.
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). 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 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.
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, although the label was restricted to patients with PD-L1-positive tumors. Roche and Chugai are pursuing label expansions for Tecentriq in both the neoadjuvant and adjuvant settings. Keytruda is expected to be approved regardless of biomarker status in the lucrative neoadjuvant/adjuvant market and is also forecast to compete with Tecentriq in the first-line market.
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 highest-selling TNBC therapies over the next 10 years.
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 will face biosimilar competition from 2019 onward.
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.
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.
Trodelvy recently 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 will experience fast uptake once launched 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 Immunomedics plans to file for a full approval in the fourth quarter of 2020.
The target population for the pipeline protein kinase B alpha (Akt) inhibitors ipatasertib and capivasertib will likely be limited to patients who present with phosphatase and tensin homolog (PTEN)/phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA)/AKT-altered tumors. Both are in development in combination with paclitaxel, and the anticipated competition between these drugs may make it difficult for one to dominate in this segment.
Key recent events include the US accelerated approval of Trodelvy, as well as a number of Phase III trial topline results, including Tecentriq's Phase III success as a neoadjuvant therapy in IMpassion031 and its failure in the Phase III IMpassion131 study.
Key upcoming catalysts for 2020 and early 2021 include the expected approvals of Keytruda as both a neoadjuvant and first-line therapy, as well as top-line results from the Phase III IPATunity130 study of ipatasertib and paclitaxel, and the Phase III FORTRESS study of POL6326 and Halaven.
The overall likelihood of approval of a Phase I breast cancer asset is 8.7%, and the average probability a drug advances from Phase III is 58.8%. Breast cancer drugs, on average, take 9.8 years from Phase I to approval, compared to 9.4 years in the overall oncology space.