All about Trodelvy

Trodelvy (sacituzumab govitecan-hziy) was approved by the US Food and Drug Administration (FDA) on February 3, 2023. Trodelvy is developed and marketed by Gilead Sciences, Inc., a biopharmaceutical company that develops innovative therapies for life-threatening diseases. Gilead acquired Trodelvy through its acquisition of Immunomedics, Inc. in 2020.

Indication

The Trop-2 targeted antibody-drug conjugate, Trodelvy, has been approved for treating adult patients facing unresectable locally advanced or metastatic breast cancer. These patients specifically have hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative tumors, as characterized by IHC 0, IHC 1+, or IHC 2+/ISH–. Eligibility criteria include prior endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Approval was secured based on highly compelling statistical significance and clinical relevance, stemming from the findings related to progression-free survival and overall survival in the Phase 3 TROPiCS-02 study. Trodelvy also holds approval in the United States for treating specific pre-treated HR+/HER2- metastatic breast cancer cases, and it has received accelerated approval for certain patients with second-line metastatic urothelial cancer.

How It Works

Trodelvy is designed to deliver potent activity to Trop-2 expressing cells and the microenvironment. It is a type of treatment called an antibody-drug conjugate (ADC) designed to work by attaching to cancer cells and delivering a toxic payload directly to them.

Dosage And Administration 

• Trodelvy 200 mg, lyophilized powder for injection in single-dose vials. Do not use it with other irinotecan drugs. Administer via intravenous infusion only, not as a bolus. Administer 10 mg/kg weekly on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity.

• Premedication is recommended to prevent infusion reactions and chemotherapy-induced nausea or vomiting. Monitor patients during and post-infusion for at least 30 minutes and consider treatment adjustments for adverse reactions.

Clinical Results

Trodelvy has significantly improved survival in pre-treated HR+/HER2- metastatic breast cancer patients in the TROPiCS-02 study. It has also been found to improve outcomes for people diagnosed with previously treated metastatic triple-negative breast cancer. A study found that Trodelvy slightly improves overall survival in heavily pre-treated metastatic, hormone receptor-positive, HER2-negative breast cancer.

Advanced Research Of Trodelvy 

Trodelvy consistently demonstrates a sustained overall survival benefit in previously treated HR+/HER2- metastatic breast cancer. Results from the ASCENT study highlight that Sacituzumab govitecan significantly enhances overall survival compared to chemotherapy in patients who have undergone prior treatments for metastatic triple-negative breast cancer.

Gilead’s Phase 2 EVOKE-02 study combining Trodelvy with Keytruda (pembrolizumab) has shown promising clinical activity in patients with metastatic or advanced triple-negative breast cancer (TNBC). This development has prompted further exploration of Trodelvy’s potential in investigational use across various cancer types, including TNBC, HR+/HER2- breast cancer, and metastatic urothelial carcinoma (UC). It is also under consideration for application in tumor types where Trop-2 is highly expressed, encompassing metastatic small cell lung cancer (SCLC), metastatic non-small cell lung cancer (NSCLC), endometrial cancer, and head and neck cancer.

Safety Information

Trodelvy may lead to severe side effects, notably low white blood cell count and diarrhea. The most frequently observed side effects of Sacituzumab govitecan encompass reduced white and red blood cell counts, fatigue, hair loss, constipation, elevated blood sugar levels, diminished protein levels in the blood, decreased appetite, alterations in kidney function test results, increased levels of the enzyme (alkaline phosphatase) in the blood (an indicator of liver or bone issues), and reduced levels of magnesium, potassium, and sodium in the blood.

Hypersensitivity reactions resulting in permanent discontinuation of Trodelvy occurred in 0.3% of cases, while anaphylactic reactions were also observed at the same rate. It is advisable to administer pre-infusion medication as a precaution.

Monitor the patients for infusion-related reactions and allergies during the treatment and for at least 30 minutes after the completion of each infusion. It is advised to discontinue Trodelvy for Grade 4 infusion-related reactions permanently. Using effective contraception during therapy with Trodelvy and for three months after the last dose is recommended.

Conclusion

Trodelvy is a promising treatment option for metastatic breast cancer. Recent research findings suggest that Sacituzumab govitecan-hziy is a promising therapy option for various types of cancer, and ongoing clinical trials are exploring its potential in other cancer types. However, it is important to be aware of its potential side effects and to follow the recommended safety guidelines. Trodelvy price in India depends on the product requirement. Request more details by contacting our Patient Support Team at ‎(+91) 93157 05373 or help@sansfro.com.  

Reference:

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf
2. https://www.breastcancer.org/research-news/trodelvy-better-for-previously-treated-tnmbc
3. https://www.trodelvy.com/patient/mtnbc/how-it-works
4. https://www.breastcancer.org/research-news/trodelvy-slightly-improves-overall-survival-for-heavily-pre-treated-metastatic-hormone-receptor-positive-her2-negative-breast-cancer
5. https://www.gilead.com/news-and-press/press-room/press-releases/2023/9/gileads-phase-2-evoke02-study-of-trodelvy-sacituzumab-govitecanhziy-in-combination-with-keytruda-pembrolizumab-demonstrates-promising-clinica