Ado-trastuzumab emtansine - Biologic Drug Details

Summary for ado-trastuzumab emtansine

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for ado-trastuzumab emtansine

Recent Clinical Trials for ado-trastuzumab emtansine

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Latin American Cooperative Oncology Group	Phase 2
Oncoclínicas	Phase 2
Jiangsu HengRui Medicine Co., Ltd.	Phase 3

See all ado-trastuzumab emtansine clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ado-trastuzumab emtansine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ado-trastuzumab emtansine Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ado-trastuzumab emtansine Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Ado-Trastuzumab Emtansine (Kadcyla)

Introduction

Ado-trastuzumab emtansine, marketed as Kadcyla, is a groundbreaking biologic drug that has revolutionized the treatment of HER2-positive breast cancer. Developed jointly by Roche and ImmunoGen, Kadcyla combines the microtubule inhibitor DM1 with the HER2 antibody trastuzumab, making it the first approved HER2-targeted antibody-drug conjugate (ADC)[4].

Approval and Regulatory Status

Kadcyla was approved by the U.S. Food and Drug Administration (FDA) in February 2013 for the treatment of patients with HER2-positive metastatic breast cancer who had previously received trastuzumab and a taxane. It has also received approval from the European Medicines Agency (EMA)[1][3].

Clinical Efficacy

The efficacy of Kadcyla has been demonstrated through several pivotal trials. The EMILIA trial, a randomized phase 3 study, showed that Kadcyla significantly improved progression-free survival (PFS) and overall survival (OS) compared to lapatinib plus capecitabine. Patients treated with Kadcyla had a median PFS of 9.6 months and a median OS of 30.9 months, compared to 6.4 months and 25.1 months, respectively, for those treated with lapatinib plus capecitabine[3][5].

Cost-Effectiveness Analysis

A cost-effectiveness analysis comparing Kadcyla to trastuzumab in patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment revealed that Kadcyla is not only more effective but also more cost-effective. The analysis showed that Kadcyla resulted in lower lifetime costs (-$40,271) and higher life-years (2.980) and quality-adjusted life-years (2.336) compared to trastuzumab[2].

Market Performance

Since its launch in 2013, Kadcyla has consistently shown strong market performance. In 2022, its global sales reached 1.89 billion Swiss francs (approximately 2.136 billion US dollars), and in 2023, this figure increased to 1.966 billion Swiss francs (approximately 2.222 billion US dollars)[4].

Sales Trends

Kadcyla has been one of the top-selling ADCs, with sales exceeding $2 billion annually. However, the market dynamics are evolving with the emergence of new competitors, such as Enhertu (trastuzumab deruxtecan), which has started to challenge Kadcyla's market dominance. Despite this, Kadcyla remains a significant player in the HER2-targeted therapy market[4].

Competitive Landscape

The ADC market has seen significant growth, with several drugs competing for market share. Enhertu, developed by Daiichi Sankyo and AstraZeneca, has been particularly successful, especially with its recent approval for HER2-low expression breast cancer. This has led to Enhertu surpassing Kadcyla in sales, with Enhertu's annual sales doubling to $2.556 billion in 2023[4].

Impact of Biosimilars

The introduction of biosimilars has also affected Kadcyla's market trajectory. While biosimilars have not yet significantly impacted Kadcyla's sales, they pose a potential threat in the future as they become more widely available and accepted by healthcare providers and patients[4].

Financial Support and Access

To ensure patient access, various financial support options are available for those taking Kadcyla. These include programs for patients without insurance and other forms of financial assistance to help mitigate the high costs associated with this treatment[5].

Clinical Trials and Expanding Indications

Kadcyla has been evaluated in several clinical trials, including the KATHERINE trial, which demonstrated its efficacy in patients with HER2-positive early breast cancer who had residual invasive disease after neoadjuvant treatment. This trial showed a significant reduction in the risk of recurrence, with a 7-year invasive disease-free survival rate of 80.8% for Kadcyla compared to 67.1% for trastuzumab[5].

Future Prospects

As research continues, Kadcyla may see expanded indications, further solidifying its position in the market. However, the competitive landscape and the emergence of new therapies will continue to shape its financial trajectory.

Safety Profile

Kadcyla has a favorable safety profile compared to other treatments. The EMILIA trial showed that Kadcyla had fewer grade 3 and above adverse events, serious adverse events, and discontinuations due to adverse events compared to lapatinib plus capecitabine[3].

Market Size and Growth

The ADC market, driven by drugs like Kadcyla, has exceeded $10 billion in sales for the first time in 2023. This growth is attributed to the targeted delivery of potent cytotoxic drugs, which has improved patient outcomes and reduced the financial burden of cancer treatment[4].

Key Statistics

• Sales: $2.222 billion in 2023[4].
• Cost-Effectiveness: Lower lifetime costs by $40,271 and higher life-years by 2.980 compared to trastuzumab[2].
• Clinical Efficacy: Median OS of 30.9 months and median PFS of 9.6 months in the EMILIA trial[3][5].
• Market Share: Second-highest selling ADC after Enhertu[4].

Conclusion

Kadcyla has established itself as a critical component in the treatment of HER2-positive breast cancer, offering significant clinical benefits and a favorable cost-effectiveness profile. Despite the rising competition, Kadcyla remains a major player in the ADC market, with a strong financial trajectory and ongoing research to expand its indications.

Key Takeaways

• Kadcyla is the first approved HER2-targeted ADC, combining trastuzumab with the microtubule inhibitor DM1.
• It has demonstrated superior efficacy in clinical trials, including improved PFS and OS.
• Kadcyla is cost-effective compared to other treatments like trastuzumab.
• The drug has seen consistent annual sales growth, though it faces increasing competition from Enhertu.
• Financial support options are available to ensure patient access.

FAQs

What is Kadcyla used for?

Kadcyla is used for the treatment of patients with HER2-positive metastatic breast cancer who have previously received trastuzumab and a taxane. It is also approved for patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment[1][5].

How does Kadcyla work?

Kadcyla works by combining the HER2 antibody trastuzumab with the microtubule inhibitor DM1 through a non-cleavable linker. This targeted delivery allows for the precise killing of HER2-positive cancer cells while minimizing damage to healthy cells[4].

What are the key clinical benefits of Kadcyla?

Kadcyla has been shown to improve progression-free survival and overall survival in patients with HER2-positive breast cancer. It also has a favorable safety profile compared to other treatments[3][5].

How does Kadcyla compare to other HER2-targeted therapies?

Kadcyla has been compared to trastuzumab and lapatinib plus capecitabine in clinical trials, showing superior efficacy and cost-effectiveness. However, it faces competition from newer therapies like Enhertu, which has also shown promising results[2][4].

What financial support options are available for patients taking Kadcyla?

Various financial support options, including programs for patients without insurance, are available to help mitigate the high costs associated with Kadcyla treatment[5].

Sources

1. Ado-trastuzumab Emtansine (Kadcyla®) Drug Description - Adc Review
2. Cost-effectiveness Analysis of Ado-trastuzumab Emtansine (T-DM1 ... - PubMed
3. 125427Orig1s000 - accessdata.fda.gov - FDA
4. Global Sales of ADCs in 2023 – UP to 10 Billion | Biopharma PEG - Biochempeg
5. Financial Support FAQs | KADCYLA® (ado-trastuzumab emtansine) - Kadcyla-hcp.com

Last updated: 2024-12-18