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ARTICLE | Clinical News

Tasquinimod: Preliminary Phase II data

November 10, 2014 8:00 AM UTC

Preliminary data from 55 patients with advanced platinum-resistant ovarian cancer in the open-label, international Phase II Umbrella trial in patients with advanced cancers that progressed after standard therapies showed that once-daily oral tasquinimod monotherapy led to a 24-week PFS rate (the primary endpoint for the ovarian cancer cohort) of 7% and a stable disease rate of 49%. Median OS was not reached in the ovarian cancer cohort. In 38 renal cell carcinoma (RCC) patients pretreated with a VEGF inhibitor, tasquinimod monotherapy led to a 16-week PFS rate (the primary endpoint for the RCC cohort) of 13%, a stable disease rate of 47% and median OS of 33 weeks. In 21 patients with gastric cancer pretreated with platinum therapy, tasquinimod monotherapy led to a 12-week PFS rate (the primary endpoint for the gastric cancer cohort) of 10%, a stable disease rate of 24% and median OS of 22 weeks. Ipsen said the data do not support further development of tasquinimod as monotherapy in heavily pretreated patients with advanced ovarian cancer, RCC and gastric cancer. The company said preliminary data from a futility analysis of 45 patients with advanced hepatocellular carcinoma (HCC) pretreated with Nexavar sorafenib showed "sufficient clinical activity" of tasquinimod monotherapy to complete enrollment of the HCC cohort, for which data are expected in 2015. Data were presented at the European Society for Medical Oncology meeting in Madrid. ...