Trodelvy (sacituzumab govitecan-hziy) is an innovative antibody-drug conjugate (ADC) that has emerged as a game-changer in the treatment of metastatic breast cancer. It is available as 180 mg and 200 mg in single-dose vials for reconstitution and Trodelvy Manufacturer is Gilead Sciences. This targeted therapy has demonstrated remarkable efficacy in patients with challenging forms of the disease, offering new hope and improved outcomes.
Mechanism of Action:
Trodelvy is a unique ADC composed of three key components:
- Sacituzumab is a monoclonal antibody that binds to the Trop-2 protein, which is highly expressed in many breast cancer cells.
- SN-38, a potent topoisomerase-I inhibitor chemotherapy agent.
- A linker that connects the antibody to the chemotherapy drug
When Trodelvy binds to the Trop-2 protein on the cancer cell surface, it is internalized, and the linker is cleaved, releasing the SN-38 chemotherapy directly into the cancer cell. This targeted delivery of the cytotoxic agent helps to selectively destroy the tumor cells while minimizing damage to healthy tissues.
Approved Indications:
Trodelvy has been approved by both the FDA and EMA to treat adults with:
- Advanced triple-negative breast cancer that can’t be removed by surgery or has spread, after at least two other treatments have been tried.
- HER2-low, hormone receptor-positive breast cancer that has metastasized after at least two prior therapies and hormone therapy have been attempted.
Clinical Efficacy:
Trodelvy has demonstrated impressive results in clinical trials for both mTNBC and HR-positive, HER2-low metastatic breast cancer.
- Metastatic Triple-Negative Breast Cancer (mTNBC): In the ASCENT trial, Trodelvy significantly improved progression-free survival (PFS) and overall survival (O.S.) compared to standard chemotherapy in patients with mTNBC who had received at least two prior therapies. The median PFS was 5.6 months with Trodelvy versus 1.7 months with chemotherapy, and the median O.S. was 12.1 months with Trodelvy versus 6.7 months with chemotherapy.
- HR-positive, HER2-low Metastatic Breast Cancer : The TROPiCS-02 study showed that Trodelvy helps patients with a specific type of advanced breast cancer:
- It improved how long patients lived without their cancer getting worse (PFS).
- It also helped patients live longer overall (OS).
- This was for patients whose breast cancer was:
- Hormone receptor-positive
- HER2-low
- Had spread to other parts of the body
These patients had already tried hormone therapy and at least two types of chemotherapy before Trodelvy.The median PFS was 5.5 months with Trodelvy versus 4.0 months with chemotherapy, and the median O.S. was 14.4 months with Trodelvy versus 11.2 months with chemotherapy.
Trodelvy is now available in Kuwait, Iraq, Oman, Qatar, Bahrain, Saudi Arabia, and the United Arab Emirates by the Indian Pharma Network offering economical Trodelvy price.
Patient Input Summary:
Two patient groups provided input for this review: Rethink Breast Cancer and the Canadian Breast Cancer Network (CBCN).
- Rethink Breast Cancer surveyed June-July 2021 with 30 patients with mTNBC from the U.S. and Canada, including 4 with direct experience using sacituzumab govitecan, who participated in interviews.
- CBCN surveyed breast cancer patients in 2012 and 2017, capturing input from 14 mTNBC patients and 1 with direct experience using sacituzumab govitecan.
Patients reported that mTNBC causes severe symptoms like pain, fatigue, and insomnia, significantly affecting their lives and financial stability. They noted the limited effectiveness and side effects of previous treatments. Feedback on sacituzumab govitecan was generally positive, with patients noting its effectiveness in disease control, extending survival, and maintaining quality of life. However, trodelvy side effects were present, and access to the drug was limited. The primary unmet needs identified were effective treatments for disease control, recurrence prevention, and symptom management with a manageable safety profile.
Expanded Approval for HR-positive, HER2-low Metastatic Breast Cancer:
In April 2023, the FDA extended Trodelvy’s approval to treat adult patients with HR-positive, HER2-low metastatic breast cancer who have previously undergone endocrine therapy and at least two other systemic treatments for metastatic disease.
This broader approval was supported by the TROPiCS-02 clinical trial findings, which showed that Trodelvy provided a significant and clinically significant enhancement in progression-free survival (PFS)and overall survival (O.S.) compared to standard chemotherapy for this group of patients.
Ongoing Clinical Trials:
Ongoing research is focused on uncovering the potential of Trodelvy injection in various settings and cancer types:
- ASCENT-03 trial: Evaluating Trodelvy as a first-line treatment for metastatic TNBC
- TROPiCS-04 trial: Examining Trodelvy’s performance in patients with HR-positive, HER2-low metastatic breast cancer who have received previous CDK4/6 inhibitor therapy.
- SEASTAR trial: Exploring Trodelvy in combination with other targeted therapies for metastatic TNBC
- TALENT trial: Looking into Trodelvy for the treatment of patients with locally advanced or metastatic solid tumors, including non-small cell lung cancer and urothelial carcinoma
These ongoing trials aim to expand the clinical utility of Trodelvy further and explore its potential in different patient populations and treatment settings. Trodelvy injection is also available in Asian countries like Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka and trodelvy cost is reasonable.
Trodelvy represents a significant advancement in the treatment of metastatic breast cancer, particularly for patients with challenging subtypes like triple-negative and HR-positive, HER2-low disease. Its unique mechanism of action and demonstrated clinical benefits make it a valuable addition to the therapies available for these patients. Indian Pharma Network (IPN) can facilitate the supply of trodelvy (prescription medicine) to locations worldwide while adhering to legal requirements.
How successful is Trodelvy?
Trodelvy has shown significant success in clinical trials. Patients treated with Trodelvy were three times more likely to be progression-free at one year compared to those receiving standard chemotherapy (21% versus 7%). Additionally, Trodelvy 180 mg and 200 mg demonstrated notable improvements in secondary endpoints, including a higher objective response rate and extended time to deterioration (TTD).
How long does Trodelvy extend life?
Trodelvy has been shown to extend life by approximately 29% compared to previous treatments. This is measured as the median overall survival (OS), indicating that half of the patients receiving Trodelvy lived about 29% longer after starting treatment compared to those on alternative therapies.
What is the target of Trodelvy?
Trodelvy specifically targets cells expressing the Trop-2 protein. Trop-2 is a cell surface protein that Trodelvy binds to in order to deliver its therapeutic effects.
Is Trodelvy expensive?
The cost of Trodelvy injection through the Indian Pharma Network is reasonable making it easier to incorporate in the treatment.
Does Trodelvy shrink tumors?
Yes, Trodelvy has been effective in shrinking tumors in clinical studies. About one-third (33%) of patients experienced tumor shrinkage, and more than half (55%) had no cancer progression for at least six months while on Trodelvy.
References:
https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy
https://everyone.org/blog/trodelvy-information
https://www.facingourrisk.org/XRAY/Trodelvy-TROPICS2-mBC
https://www.trodelvy.com/patient/mtnbc/how-it-works
https://make2ndscount.co.uk/news/blog/trodelvy-for-secondary-breast-cancer-science-and-stories
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-trodelvy-her2-low-metastatic-breast-cancer
https://clinicaltrials.gov/ct2/show/NCT05141539
https://clinicaltrials.gov/ct2/show/NCT05359393
https://clinicaltrials.gov/ct2/show/NCT04795881
https://clinicaltrials.gov/ct2/show/NCT04596150
