Sacituzumab govitecan-hziy - Biologic Drug Details

Summary for sacituzumab govitecan-hziy

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sacituzumab govitecan-hziy

Recent Litigation for sacituzumab govitecan-hziy

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Highland Capital v. NexPoint Asset	2023-09-06
Highland v. NexPoint	2023-09-06
Highland Capital Management, L.P. - Adversary Proceeding	2021-01-22

See all sacituzumab govitecan-hziy litigation

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 sacituzumab govitecan-hziy Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for sacituzumab govitecan-hziy Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for sacituzumab govitecan-hziy Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Sacituzumab Govitecan-Hziy

Introduction

Sacituzumab govitecan-hziy, marketed as Trodelvy, is a biologic drug that has made significant strides in the treatment of various types of cancer. Developed by Immunomedics and now managed by Gilead Sciences, this Trop-2-directed antibody drug conjugate has seen both successes and challenges in its market dynamics and financial trajectory.

FDA Approvals and Indications

Metastatic Triple-Negative Breast Cancer

Trodelvy received its first accelerated approval from the FDA on April 22, 2020, for adult patients with metastatic triple-negative breast cancer (mTNBC) who had received at least two prior therapies for metastatic disease. This approval was based on the overall response rate (ORR) and response duration from the IMMU-132-01 trial[1].

HR-Positive Breast Cancer

On February 3, 2023, the FDA approved Trodelvy for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who had received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting[5].

Urothelial Cancer

Although Trodelvy initially received accelerated approval for adult patients with locally advanced or metastatic urothelial cancer in April 2021, this indication was withdrawn in 2024 following negative results from the phase 3 TROPiCS-04 trial, which failed to meet the primary endpoint of overall survival (OS)[3].

Clinical Trials and Efficacy

Metastatic Triple-Negative Breast Cancer

The efficacy of Trodelvy in mTNBC was demonstrated in the IMMU-132-01 trial, showing an ORR of 33.3% and a median response duration of 7.7 months[1].

HR-Positive Breast Cancer

For HR-positive breast cancer, the primary efficacy outcome measure was progression-free survival (PFS) determined by blinded independent central review per RECIST v1.1. The trial randomized patients to receive either Trodelvy or chemotherapy, with Trodelvy showing promising results in this setting[5].

Urothelial Cancer

Despite the withdrawal from the urothelial cancer market, the TROPiCS-04 trial did show numerical improvements in OS and trends in improvement on secondary endpoints like PFS and ORR in pre-specified subgroups, though these were not statistically significant[3].

Safety Profile

Trodelvy is associated with several common adverse reactions, including nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, and abdominal pain. Severe neutropenia and diarrhea are notable concerns, with Gilead emphasizing the importance of granulocyte-colony stimulating factor (G-CSF) use to prevent neutropenic complications[1][3].

Financial Performance

Revenue Growth

Trodelvy has been a significant contributor to Gilead's oncology product sales. In FY23, Trodelvy sales grew by 28% year-over-year (YoY) to $1.9 billion, driven by strong demand across various indications. In Q4 2023, Trodelvy sales continued to grow, with a 11% YoY increase[2].

Market Dynamics

The success of Trodelvy has been part of Gilead's broader oncology portfolio growth, which saw a 37% YoY increase in FY23. The drug's performance has been consistent, with Q3 2024 sales showing a 17% YoY increase, contributing to Gilead's overall strong financial performance in the oncology segment[2][4].

Ongoing Clinical Trials

Despite the setback in the urothelial cancer indication, there are over 20 ongoing clinical trials assessing Trodelvy as a monotherapy and in combination with other agents in patients with solid tumors. These trials include combinations such as those in the VELOCITY-Lung and EDGE-Lung programs, which are part of Gilead's expansive oncology pipeline[3][4].

Competitive Landscape

Trodelvy operates in a competitive oncology market, but its unique mechanism of action and efficacy in specific cancer types have helped it carve out a significant market share. Gilead's ongoing efforts to establish partnerships with leading community networks and its strong commercial performance indicate a robust competitive position[2][4].

Future Outlook

The withdrawal of Trodelvy from the urothelial cancer market is a setback, but the drug's continued approval and success in other indications, such as mTNBC and HR-positive breast cancer, ensure its financial trajectory remains positive. Gilead's commitment to further investigating the data from the TROPiCS-04 trial and its ongoing clinical trials suggest that Trodelvy will remain a key player in the oncology market.

Key Takeaways

• Multiple Indications: Trodelvy is approved for metastatic triple-negative breast cancer and HR-positive breast cancer, with a withdrawn indication for urothelial cancer.
• Strong Financial Performance: Significant revenue growth in FY23 and Q4 2023, contributing to Gilead's overall oncology portfolio success.
• Ongoing Clinical Trials: Over 20 trials assessing Trodelvy in various solid tumors, including combination therapies.
• Safety Profile: Associated with common adverse reactions, emphasizing the need for G-CSF to prevent neutropenic complications.
• Competitive Position: Unique mechanism and efficacy help maintain a strong market share despite competition.

FAQs

What is sacituzumab govitecan-hziy (Trodelvy)?

Sacituzumab govitecan-hziy, marketed as Trodelvy, is a Trop-2-directed antibody drug conjugate used in the treatment of certain types of cancer.

What are the approved indications for Trodelvy?

Trodelvy is approved for adult patients with metastatic triple-negative breast cancer (mTNBC) and unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Why was Trodelvy withdrawn from the urothelial cancer market?

Trodelvy was withdrawn from the urothelial cancer market following negative results from the phase 3 TROPiCS-04 trial, which failed to meet the primary endpoint of overall survival (OS).

What are the common adverse reactions associated with Trodelvy?

Common adverse reactions include nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, and abdominal pain.

How has Trodelvy performed financially?

Trodelvy has seen significant revenue growth, contributing to Gilead's strong financial performance in the oncology segment, with a 28% YoY increase in FY23 and continued growth in subsequent quarters.

Sources

1. FDA: FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple-negative breast cancer.
2. Gilead Sciences: Q4 & FY23 Financial Results.
3. Urology Times: Sacituzumab govitecan withdrawn from bladder cancer market following negative trial.
4. Gilead Sciences: Q3 2024 Financial Results.
5. FDA: FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer.

Last updated: 2024-12-19