Tracon Pharma Says Phase 2 TRAXAR Trial Fails To Meet Primary Endpoint

(RTTNews) - Tracon Pharmaceuticals (TCON) said that its Phase 2 TRAXAR trial evaluating TRC105 in combination with Inlyta or axitinib in patients with advanced or metastatic renal cell carcinoma did not meet the primary endpoint of improving progression free survival or PFS in the intent to treat population compared to Inlyta monotherapy.

Prespecified statistical analyses of PFS according to expression of two plasma biomarkers, TGFß receptor III and osteopontin, also did not achieve statistical significance. The safety profile observed in TRAXAR was consistent with that observed in previously reported studies of TRC105 in combination with VEGF inhibitors.

TRACON said it will work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

"We are disappointed that TRC105 in combination with Inlyta did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic renal cell carcinoma. Importantly, data from TRAXAR, including analyses of an extensive biomarker panel, will contribute to our understanding of the role of endoglin inhibition in combination with VEGF inhibitors, and may inform our broad TRC105 clinical development program," said Charles Theuer, President and CEO of TRACON.

"We remain focused on the interim analysis to determine the final sample size of the Phase 3 TAPPAS trial of TRC105 and Votrient in angiosarcoma, which is expected in the first quarter of 2019," said Charles Theuer.