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Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer
Date:11/20/2008

he ET743-OVA-301 Study

Patients were enrolled at 124 centers in 21 countries. Per the study protocol, the data were evaluated by a blinded, independent radiology review and a blinded, independent oncology review. The trabectedin/DOXIL combination demonstrated a statistically significant improvement in PFS compared to DOXIL alone (median PFS 7.3 versus 5.8 months, respectively) and a statistically significant reduction of 21% in the risk of progression or death during the observation period in the independent review of patients with radiologically measurable disease (HR=0.79, 95% CI (0.65;0.96), p=0.0190). This result is consistent with the results of the independent oncology review that takes into account clinical as well as imaging data in the assessment of progression. In this review, there was a 28% risk reduction for disease progression or death with the trabectedin/DOXIL combination (HR=0.72, 95% CI (0.60; 0.88), p=0.0008).

Secondary endpoints included response rate, overall survival, and safety. A statistically significant increase in response rate was seen with the trabectedin and DOXIL combination (28%) compared to DOXIL alone (19%), as measured by the independent radiology review. A final protocol-specified survival analysis is planned after the occurrence of 520 events. The safety profile in the study was consistent with previous experience with trabectedin and DOXIL.

The most common adverse reactions (greater than or equal to 20%) for the trabectedin/DOXIL combination compared to DOXIL alone, respectively, were:

  • Hematological reactions including neutropenia (77% versus 38%, with febrile neutropenia occurring in 8% of the cases and sepsis in 1% of the cases), leucopenia (48% versus 26%), anemia (48% versus 25%) and thrombocytopenia (36% versus 8%);
  • Gastrointestinal reactions including nausea (74% versus 42%), vomiting (56% versus 30%) and d
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SOURCE Ortho Biotech Products, L.P.
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