TRACON Pharmaceuticals reports Phase 1b data on TRC105-Inlyta combo
TRACON announced final updated results from a Phase 1b clinical trial combining TRC105 with Inlyta in patients with advanced or metastatic renal cell carcinoma. Results showed an ORR of 29%, a stable disease rate of 59%, an overall disease control rate of 88%, median PFS of 11.3 months, and median PFS in the clear cell RCC subset of 11.3 months. The recommended Phase 2 dose of TRC105 of 10 mg/kg dosed weekly was well-tolerated in combination with Inlyta and no dose limiting toxicities were observed. The Inlyta dose was escalated from 5 mg BID to 7 mg BID in 22% of patients and to 10 mg BID in 11% of patients. Serum concentrations of TRC105 above target concentrations were maintained continuously at the 8 mg/kg and 10 mg/kg TRC105 dose levels. Plasma levels of TGF-b receptor 3 at baseline were significantly higher in patients with a partial response, while levels of osteopontin were significantly lower at baseline for patients that achieved a partial response. Both markers correlated with time on study and their potential prognostic/predictive value are being investigated in the Phase 2b TRAXAR study. All patients in TRACON's Phase 1b study have now completed treatment and the randomized Phase 2b TRAXAR clinical trial of TRC105 in combination with Inlyta is currently enrolling patients with advanced or metastatic RCC. TRACON expects top-line data from the TRAXAR study to be available in the first half of 2017.