Morphotek Phase III study of farletuzumab fails to meet primary endpoint

13th January 2013 (Last Updated January 13th, 2013 18:30)

Morphotek has announced that the Phase III study of farletuzumab conducted in patients with relapsed platinum-sensitive epithelial ovarian cancer has failed to meet the primary endpoint of progression-free survival (PFS).

Morphotek has announced that the Phase III study of farletuzumab conducted in patients with relapsed platinum-sensitive epithelial ovarian cancer has failed to meet the primary endpoint of progression-free survival (PFS).

The Phase III trial, also known as FAR 131, was a randomised, multicentre, double-blind, placebo-controlled study designed to assess the investigational agent farletuzumab (MORAb-003) in combination with carboplatin and a taxane in 1,100 patients.

Morphotek president and CEO Dr. Nicholas Nicolaides said the company is disappointed with the results.

"The Phase III trial, also known as FAR 131, was a randomised, multicentre, double-blind, placebo-controlled study designed to assess the investigational agent farletuzumab (MORAb-003) in combination with carboplatin and a taxane in 1,100 patients."

"Morphotek remains committed to research to understand the potential role of farletuzumab in ovarian and other types of cancer," Nicolaides said.

According to the preliminary safety analysis, the most commonly reported adverse events were linked with the study's chemotherapy agents while some immune-mediated events were observed with farletuzumab.

In the double-blind, placebo-controlled study, patients were enrolled to receive standard-of-care (carboplatin and a taxane [paclitaxel or docetaxel]) chemotherapy every three weeks for approximately six cycles.

Patients were randomised to three parallel groups to receive either 1.25mg/kg of farletuzumab, 2.5mg/kg of farletuzumab, or placebo every week for approximately six cycles.

After approximately six cycles, patients received maintenance of placebo, 1.25mg/kg or 2.5mg/kg of farletuzumab until progression.

The company is conducting further analysis, after which a new development strategy will be determined.