Tracon's lead product candidate fails in phase 2 study in brain cancer trial
Tracon Pharmaceuticals said that data from a phase 2 study demonstrated that a combination of its endoglin antibody TRC105 with Avastin (bevacizumab) did not perform significantly better than Avastin alone for progression-free survival in patients with recurrent glioblastoma.
The study was conducted by the Clinical Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).
In the trial, TRC105 combined with Avastin (bevacizumab) was compared to single agent Avastin in a total of 101 patients with recurrent GBM following chemoradiation. The trial was designed to detect a three-month improvement in progression free survival (PFS), the primary endpoint, from the expected value of 3.45 months with single agent Avastin.
Top-line data indicate that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed data and the associated correlative analyses are expected to be presented at an oncology conference later this year.
Tracon CEO president and CEO Charles Theuer, M.D., Ph.D. said: “Glioblastoma is a very challenging indication for drug development.
“We are grateful to the National Cancer Institute for sponsoring the trial and to the patients and providers who participated, and look forward to the detailed survival analysis from this trial, as well as data from multiple company-sponsored trials of TRC105 in other indications later this year.”
TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in one Phase 3 and multiple Phase 2 clinical trials sponsored by Tracon or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors.
The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis.
Source: Company Press Release