The trial was conducted by Roche and Genentech, Curis’ collaborator and a wholly owned member of the Roche Group.
GDC-0449 is being developed by Roche and Genentech under a collaboration agreement between Curis and Genentech. GDC-0449 was tested in combination with Avastin (bevacizumab) and Folfox or Folfiri chemotherapy in first-line metastatic colorectal cancer patients.
Roche has informed Curis that the trial did not meet its primary endpoint of extending the time from randomisation to disease progression or death in study patients who received GDC-0449 in addition to the current standard of care of bevacizumab and chemotherapy when compared to those patients that received only the current standard of care treatment.
Genentech and Roche are also conducting a randomised double-blind placebo-controlled Phase II trial in advanced ovarian cancer in a maintenance setting, which is evaluating the ability of GDC-0449 to slow the time to recurrence of cancer in patients whose disease is in complete remission, by impeding the residual cancer cells’ ability to grow. Roche has indicated that results from this study are expected during the second half of 2010.
GDC-0449 was well tolerated in this Phase I study. Roche has indicated that it expects data from the pivotal Phase II study in 2011 and, pending successful results, that it could also submit regulatory approval submissions in 2011.
Dan Passeri, president and CEO of Curis, said: “Despite these disappointing results in metastatic colorectal cancer, we remain encouraged that Genentech and Roche’s clinical development of GDC-0449 in other cancers continues to make good progress.”