FDA Grants Fast Track Designation to Sacituzumab Govitecan for Locally-advanced or Metastatic Urothelial Cancer
Immunomedics, Inc, a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting, including patients who are platinum ineligible and have previously received a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.
“Coming in the wake of a recent unanimous recommendation by the independent Data Safety Monitoring Committee for the ASCENT study to stop the trial due to compelling evidence of efficacy in metastatic triple-negative breast cancer, it is gratifying to learn of the FDA’s recognition of sacituzumab govitecan’s potential in urothelial cancer, an important second indication for our lead antibody-drug conjugate. With the upcoming maturation of the data from the 100-patient cohort with prior platinum-based and PD-1 or PD-L1 inhibitor therapies, and based on the Fast Track designation, we will actively seek guidance from the FDA on a potential accelerated approval pathway,” said Loretta M. Itri, M.D., Chief Medical Officer at Immunomedics.
Sacituzumab govitecan is currently being evaluated in the Phase 2 TROPHY U-01 study of patients with mUC. Interim results from 35 patients included in the 100-patient cohort of cisplatin-eligible patients who have relapsed or are refractory to PD-1 or PD-L1 inhibitor and platinum-based chemotherapy were presented at the 2019 European Society for Medical Oncology (ESMO) Annual Congress and showed an overall response rate of 29 percent, consistent with previously reported data in this population.
Enrollment for the full cohort of 100 patients with prior platinum-based and PD-1 or PD-L1 inhibitor therapies has been completed, with topline data expected to be available in the second half of 2020. While enrollment for the second cohort of 40 cisplatin-ineligible patients is expected to be completed later this year, the company has recently broadened the study to include a third cohort of PD-1 or PD-L1 inhibitor-naïve patients to assess the combination of sacituzumab govitecan with pembrolizumab.