- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Ovarian Cancer Drug Fails Mid-Stage Trial
No survival improvement with monoclonal antibody (October 30)
Disappointing results have been reported from a phase II, open-label, randomized study of MM-121 (Merrimack Pharmaceuticals) in combination with paclitaxel versus paclitaxel alone in patients with platinum-resistant or platinum-refractory advanced ovarian cancers.
The study did not meet its primary endpoint of progression-free survival (PFS) in the overall population. The hazard ratio for PFS was 1.0 (95% confidence interval, 0.74–1.4).
In addition, an overall increase in all grades of gastrointestinal toxicities, including diarrhea (73.6% vs. 42.5%), vomiting (31.4% vs. 18.8%), and other mucosal toxicities, such as rhinitis (7.1% vs. 1.3%), epistaxis (23.6% vs. 17.5%), stomatitis (22.1% vs. 10.0%), and mucosal inflammation (22.1% vs. 1.3%), were observed in subjects treated with MM-121 and paclitaxel compared with paclitaxel alone. Moreover, an increase in the pulmonary embolism rate was observed with the combination of MM-121 and paclitaxel (5.0% vs. 1.2%).
MM-121 is a fully human monoclonal antibody that targets ErbB3, a cell-surface receptor implicated in tumor growth and survival. By inhibiting ErbB3 signaling, MM-121 was designed to restore sensitivity, delay resistance, and enhance the anti-tumor effect of a combination-therapy partner.
Source: Merrimack Pharmaceuticals; October 30, 2013.