Yondelis (trabectedin) stabilized a form of advanced mesothelioma that had progressed after earlier chemotherapy, according to a Phase 2 clinical trial in Italy.
Researchers will present the trial’s findings at the American Society of Clinical Oncology annual meeting in Chicago, June 2-6. PharaMar developed Yondelis, but sold the rights to it in most countries to Janssen Products.
A research team from Azienda Ospedaliera San Gerardo Hospital led the study, titled “Trabectedin (T) as second line treatment option for patients with epithelioid malignant pleural Mesothelioma (MPM) in progression following pemetrexed/platinderivates chemotherapy: ATREUS trial.”
The ATREUS trial (NCT02194231) covered patients with the epithelioid version of mesothelioma whose disease had relapsed after chemo. It also covered both previously treated and untreated patients with sarcomatoid mesothelioma.
Researchers enrolled 71 patients in the trial, most of them men. Their average age was 65.8 years. Eighty-three percent had the most advanced stages of mesothelioma: 3 and 4.
The Mario Negri Institute for Pharmacological Research sponsored the study and recruited the patients from several Italian cancer centers.
To start with, patients received 1.3 mg/m2 of Yondelis intravenously every 21 days. When that dose proved difficult for some to tolerate, researchers reduced it to 1.1 mg/m2.
Fifty-nine of the patients completed 12 weeks of the treatment, discontinued it because their disease progressed, or died before the treatment period ended.
Yondelis stopped the progression of the disease in 25 of the 59, or 42.4 percent, at 12 weeks. This met the trial’s primary goal of 20 patients achieving progression-free survival during treatment.
The most common moderate-level side effects were liver toxicity in 60.5 percent of participants, low levels of white blood cells known as neutrophils in 21.1 percent, and fatigue in 6.6 percent.
Five patients discontinued the treatment because of side effects. Two had liver toxicity, one experienced multi-organ failure, one had low blood platelet counts, and one was unable to tolerate Yondelis.
Although researchers found the safety data promising, they said the drug’s safety needs further evaluation.