Novartis Phase III Trial Examining EPO906 (Patupilone) For Patients With Advanced Ovarian Cancer Failed To Meet Primary Endpoint
Novartis announced recently that patupilone (EPO906) did not show a significant overall survival advantage in a phase III trial of patients with advanced ovarian cancer, refractory or resistant to platinum-based therapy The comparator arm in the trial was Doxil/Caelyx (pegylated liposomal doxorubicin).
Investigators involved in the study and regulatory agencies have been notified of the trial outcome. No new or unexpected serious adverse events in the patupilone arm were identified in the trial. Novartis does not plan to proceed with regulatory filings based on these data.
Study details
The Phase III study, conducted in approximately 168 sites in 22 countries, was an open label, active controlled, parallel group, multicenter trial of 829 patients with epithelial ovarian, primary fallopian or primary peritoneal cancer, who were randomized to receive patupilone or Doxil/Caelyx. Before enrollment in the trial, patients had received up to a maximum of three prior chemotherapeutic regimens, of which the first was a taxane/platinum therapy. Patients were randomly assigned to intravenous patupilone (10 mg/m2) once every three weeks or Doxil®/Caelyx® (50 mg/m2) once every four weeks and were evaluated for disease status by Ca-125 and CT scans every eight weeks until disease progression. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, safety and overall response rate.
About patupilone
Patupilone belongs to a class of microtubule stabilizers called epothilones and is being evaluated in ongoing trials in multiple tumor types, including metastatic colorectal cancer, brain metastases in non-small cell lung cancer (NSCLC) and hormone-refractory prostate cancer (HRPC).
Because it is an investigational compound, the safety and efficacy profile of patupilone has not yet been established. This investigational compound is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of uncertainty of clinical trials, there is no guarantee that patupilone will ever be commercially available anywhere in the world.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3B, while approximately USD 7.5B was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, visit http://www.novartis.com.
SOURCE: Novartis