Ovarian Cancer Treatment Meets Phase 3 Primary Endpoints

Recently, Oasmia Pharmaceutical announced positive overall survival results for Paclical/Apealea in a phase 3 study.

This study included 789 patients with epithelial ovarian cancer who either received Paclical or Taxol (also a paclitaxel-based product) combined with carboplatin. Currently, paclitaxel combined with carboplatin is the standard treatment for patients with epithelial ovarian cancer.

Researchers found the period from randomization to relapse or death for Paclical and carboplatin was 10.3 months compared with 10.1 months for Taxol and carboplatin, according to the study.

The overall survival in patients receiving Paclical and carboplatin was 25.7 months, versus 24.8 months in patients receiving Taxol and carboplatin.

Oasmia said these results show non-inferiority between these 2 treatments and, therefore, the study achieved its primary endpoint.

“It was expected that the analysis of the OS [overall survival] data would show non-inferiority and confirmation of the PFS [progression-free survival] results, two key factors for why we believe Apealea is an alternative to the presently available treatments of ovarian cancer,” said Margareta Eriksson, vice president of clinical development at Oasmia Pharmaceutical. “Ovarian cancer is a fatal disease, one that is the fifth leading cause of cancer related deaths in women, and of which it is estimated that there will be over 22,000 new cases in the United States in 2016. Today, the treatment is designed to postpone fatality and to improve the quality of life for these patients.”

Oasmia concluded that they plan to submit an application for to the FDA for approval of Paclical/Apealea by the end of 2016 or 2017.