Immunomedics obtains Fast Track designation for sacituzumab govitecan
On Monday Immunomedics (IMMU) announced that its Phase 3 confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee, during its recent routine review of the ASCENT study.
ASCENT is a Phase 3 confirmatory study designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated patients with metastatic TNBC. The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others.
A biologics license application resubmission seeking accelerated approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease is currently under U.S. Food and Drug Administration review, with a PDUFA target action date of June 2, 2020.
The FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan in this disease setting.
Today Immunomedics announced that the U.S. Food and Drug Administration has granted Fast Track designation for sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death-ligand 1 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.
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 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-naive patients to assess the combination of sacituzumab govitecan with pembrolizumab.
Urothelial cancer refers to cancer that begins in cells called urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs. Urothelial cells are also called transitional cells. These cells can change shape and stretch without breaking apart. Also called transitional cell cancer.
IMMU is up 59 cents to $19.37. Shares jumped yesterday from $5.35 to $20 before closing at $18.70.
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