TRACON Pharmaceuticals presented final results from a phase 1b clinical trial combining TRC105 with Inlyta® (axitinib) in patients with advanced or metastatic renal cell carcinoma (RCC) at the European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark, earlier this week.
This study was an open-label, dose escalation and expansion phase 1b study, which enrolled a total of 17 evaluable patients who had received at least one prior treatment with a VEGF receptor tyrosine kinase inhibitor (VEGFR TKI). The median objective response rate (ORR) was 29%, and 59% of patients achieved stable disease with overall disease control being 88%. Median progression-free survival was 11.3 months.
For comparison, the objective response rate (ORR) seen in the phase 3 AXIS trial with axitinib in second-line clear cell RCC patients (a separate trial) was 11.3%, and median progression-free survival (PFS) was 4.8 months.
All patients in the study have now completed treatment, and the randomised phase 2b TRAXAR clinical trial of TRC105 in combination with axitinib is currently enrolling patients with advanced or metastatic RCC.