On November 11, 2016 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported updated data from the Company’s Phase 1b/2 study of TRC105 and Votrient (pazopanib) at the Connective Tissue Oncology Society (CTOS) annual meeting taking place in Lisbon, Portugal (Press release, Tracon Pharmaceuticals, NOV 11, 2016, View Source [SID1234516501]). Schedule your 30 min Free 1stOncology Demo! In poster presentation 2569989 entitled, "TRC105 in Combination with Pazopanib in Patients with Advanced Angiosarcoma," data from 18 angiosarcoma patients treated with either the combination of TRC105 (carotuximab) and Votrient, or with single agent TRC105 followed by the combination of TRC105 and Votrient, were presented:
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For the initial five angiosarcoma patients enrolled in the original Phase 1b/2 clinical trial, the median progression-free survival (mPFS) is greater than 16.6 months. For the nine chemotherapy-refractory angiosarcoma patients treated with the combination of TRC105 and Votrient, three of whom had also previously progressed on Votrient treatment (and includes the initial five patients), mPFS is 5.6 months. Three of the nine patients remain on treatment, including two patients with durable complete responses (CRs), now on treatment for 19 and 26 months, respectively. For comparison, mPFS with single agent Votrient was 3.0 months with no CRs in a previously completed retrospective analysis of 30 chemotherapy-refractory and Votrient-naive angiosarcoma patients.
An additional group of nine angiosarcoma patients was enrolled and treated initially with single agent TRC105 followed by the combination of TRC105 and Votrient at progression. The mPFS in these nine patients treated initially with single agent TRC105 was similar to the mPFS reported in late-stage trials of single agent VEGF inhibitors, including Votrient and Nexavar (sorafenib). Four of the nine patients remain on study with either single agent TRC105 or the combination of TRC105 and Votrient, including one patient with a partial response.
TRC105 administered at its recommended Phase 2 dose of 10 mg/kg weekly was well-tolerated in combination with Votrient at its approved dose, which allowed for prolonged dosing without an increase in the frequency or severity of adverse events typical of each individual drug.
"The combination of TRC105 and Votrient has now been used to treat a total of 18 angiosarcoma patients and we continue to see encouraging signs of activity in this group of patients with limited therapeutic options," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Looking forward, we remain on track to initiate a randomized Phase 3 study of TRC105 with Votrient in patients with angiosarcoma at sites in the U.S. and Europe later this year or early 2017. Using the valuable input previously received from both U.S. and EU regulators, the trial will utilize an adaptive design that allows sample size re-estimation and patient enrichment. Importantly, we have submitted the trial design to the FDA for a Special Protocol Assessment (SPA)."
The poster is available on TRACON’s website at www.traconpharma.com.
About TRC105 (carotuximab)
TRC105 (carotuximab) 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 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.