PharmaMar reported positive results from a phase III trial of Yondelis for the treatment of ovarian cancer. This randomized study enrolled 627 women with ovarian cancer who had relapsed after receiving standard first-line chemotherapy, across several international sites.
The subjects received Yondelis in combination with Doxil (pegylated liposomal doxorubicin) or Doxil alone. The primary endpoint, progression-free survival, was reached with statistical significance. Median progression-free survival was 7.3 months for subjects who received the combination of Yondelis and Doxil versus 5.8 months for those treated with Doxil alone (p=0.019), for a clinically meaningful 21% reduction in the risk of progression or death. There was an increased response rate with the Yondelis and Doxil combination of 28% versus Doxil alone (19%), as measured by a blinded radiology review.
The secondary endpoint of overall survival has not been determined, however a positive trend with a 15% reduction in the risk of death favored the Yondelis and Doxil treatment group. Treatment was generally well tolerated.
Based on the results, PharmaMar and plans to file an MAA with the EMEA and, with their U.S partner, an NDA with the FDA, both before the end of 2008.