TRACON Pharmaceuticals (NASDAQ:TCON) has released updated clinical results from its pivotal envafolimab study in MSI-H/dMMR cancer patients. TRACON’s corporate partners Alphamab Oncology and 3D Medicines, presented the results recently.
Data presented at the 2020 CSCO
The partners presented the clinical data during the 2020 Chinese Society of Clinical Oncology virtual Scientific Program. The presentation was titled “Subcutaneous Injection of PD-L1 Antibody Envafoliab (KN035) in advanced Tumpors with Mismatch-Repair Deficiency.” Results showed that single-agent envafolimab had a 32% objective response rate through central radiographic appraisal of 41 MSI-H/dMMR colorectal cancer patients with failed oxaliplatin, fluoropyrimidine, and irinotecan with around 2 on-study tumor evaluations.
Also, the response duration was more than or equal to twelve months in around 75% of the patients with overall survival being more than 12 months in almost 65% of the patients. There was 43% ORR in the overall population and more than 12 months in terms of DOR in around 92% of the patients. Interestingly, envafolimab showed good safety and tolerability profile without any infusion-linked reactions.
The study enrolled 103 patients in China
The study, which was an open-label trial enrolled 103 MSI-H CRC patients at clinical sites in China. The primary endpoint was confirmed ORR with the status of MSI-H/dMMR evaluated centrally for GC and CRC. Patients with MSI-H/dMMR colorectal cancer that had failed oxaliplatin, irinotecan, and fluoropyrimidine treatment who were treated with envafoliumab had Confirmed ORR of 32%, which is almost the same as the confirmed ORR of 2% in the Opdivo package insert and 27.9% for Keytruda in MSI-H/dMMR colorectal cancer.
James Freddo, the company’s chief medical officer, indicated that the data presented at the CSCO 2020 offers clinical evidence on the activity of envafolimab, which is similar to that of Keytruda and Opdivo in MSI-H/dMMR cancer. He added considering the ORR of 4% reported in the pivotal Votrient study, which is the only approved therapy for refractory MFS and UPS, and the shown efficacy of the checkpoint inhibitors in the populations, it is evident that the ENVSARC pivotal clinical study results positions envofalimab as transformative standard care for sarcoma individuals.