TRACON Pharmaceuticals Inc (NASDAQ:TCON), which is planning to start the ENVASARC study of its envafolimab novel, single-domain antibody in combination with immunotherapy Yervoy as a treatment for sarcoma later in 2020, has highlighted data from a separate study that buoys the potential of its drug.
In a statement Friday, the company cited a study done by the Alliance for Clinical Trials in Oncology at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.
TRACON said the Alliance study reported an impressive 29% confirmed objective response rate (ORR) in patients with highly refractory Undifferentiated Pleomorphic Sarcoma (UPS) who received Opdivo, a prescription medication that treats certain types of cancer, in combination with Yervoy in a non-comparative randomized trial.
READ: TRACON Pharmaceuticals believes its ENVASARC trial on envafolimab will enable a quick path to market
TRACON itself recently reported data at ASCO 2020 showing that single-agent envafolimab demonstrated a 30% confirmed ORR in 50 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan or those with advanced gastric cancer who failed at least one prior systemic treatment or had at least two on-study tumor assessments.
TRACON said the confirmed ORR in CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan.
“We believe these data bode well for the ENVASARC trial, which will assess the potential of envafolimab as a single agent and in combination with Yervoy in UPS that has progressed following one or two prior lines of treatment,” Dr James Freddo, TRACON’s chief medical officer said in a statement.
“Given the ASCO 2020 data indicating that envafolimab’s activity is similar to that of Opdivo in MSI-H/dMMR cancer, but without infusion-related reactions, we believe our trial’s objective of targeting a 15% ORR in ENVASARC is achievable.”
He added: “Moreover, given the 4% ORR of Votrient, the only approved therapy for refractory UPS and myxofibrosarcoma, a sarcoma subtype genetically related to UPS that will also be included in ENVASARC, we believe envafolimab combined with Yervoy could provide a transformative new standard of care for sarcoma patients.”
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