Yondelis Clinical Trials

What are Yondelis Clinical Trials?

Yondelis is the brand name of trabectedin, an antitumor medication. It is used to treat advanced ovarian cancer and soft-tissue sarcoma, which has metastasized, spreading over to other parts of the body. It is the last resort when other chemotherapy treatments have proven ineffective and surgical resection is impossible.

Manufactured and sold by Pharma Mar S.A. and Johnson and Johnson, Yondelis was FDA-approved in 2016 and is classified as an orphan drug, which means it is manufactured by government assistance because it is for such a rare condition that it is not profitable.

Side effects of Yondelis include nausea, vomiting, constipation, diarrhea, headaches, decreased appetite, and shortness of breath. Severe side effects can be fatal, including severe infections due to decreased white blood cell counts, muscle problems (rhabdomyolysis), liver problems, heart muscle problems, and capillary leak syndrome.

Why Is Yondelis Being Studied Through Clinical Trials?

For patients with metastatic ovarian cancer, the five-year survival is only 18%, and for metastatic soft tissue sarcoma, it is 16%. These low rates make drugs such as Yondelis important for slowing down the spread of cancerous cells that cannot be surgically removed, thus increasing the survival rate.

Clinical trials are currently underway to study the long-term safety of Yondelis and its effectiveness in treating other cancers that have metastases, such as breast, prostate, and pediatric cancers.

How Does Yondelis Treatment Work?

Although not completely understood, trabectedin blocks the action of DNA transcription of tumors, thus slowing down cancerous growth. However, because of its life-threatening side effects, it is prescribed as a last resort. By the time cancer has spread to other parts of the body, its benefits outweigh the risks, and it can give a patient a few more livable years.

15 mg/m² of Yondelis is administered intravenously through a central venous line over 24 hours as there is a risk of the medication leaking from the site, which can damage cells in that area. This is repeated every three weeks until the cancer progresses or the side effects have reached an unacceptable level.

What are Some Recent Yondelis Clinical Trial Breakthroughs?

2010: This multicenter clinical trial studied the effects and safety of trabectedin in patients with advanced relapsed ovarian cancer. Sponsored by Johnson & Johnson Pharmaceutical Research & Development, 637 patients were enrolled, and the survival rates were compared between trabectedin + DOXIL with DOXIL monotherapy. Results showed that patients with limited treatment options could benefit from trabectedin, which decreased the symptoms associated with cancer, improving progression-free survival.

2021: This clinical trial studied the effectiveness of trabectedin with doxorubicin as a first-line treatment for soft tissue sarcoma leiomyosarcoma. One hundred fifty patients were enrolled in this trial, and they received 60 mg/m² of intravenous doxorubicin, then 1.1 mg/m² of trabectedin on day 1 and the next day pegfilgrastim, every three weeks for six consecutive cycles. Results showed that the combination drug was effective in both progression-free survival and overall survival.