Biopharmaceutical company Immunomedics has stopped the confirmatory Phase III ASCENT clinical trial of sacituzumab govitecan early after obtaining encouraging efficacy data in metastatic triple-negative breast cancer (mTNBC) patients.
ASCENT was performed to confirm the safety and efficacy of the drug in a Phase II trial of heavily pretreated patients suffering from mTNBC.
The primary endpoint of the Phase III trial is progression-free survival, while secondary endpoints include overall survival and objective response rate.
Based on the encouraging results observed during ASCENT, an independent Data Safety Monitoring Committee (DSMC) recommended that the study be discontinued.
University of Washington School of Medicine breast cancer professor Julie Gralow said: “TNBC is a disease with extremely limited treatment options beyond classic chemotherapy.
“The remarkable results we observed across multiple endpoints in the ASCENT study warranted early discontinuation of the trial and are indicative of a potential major advance in the treatment of this devastating disease that affects younger women and African American women at higher rates.”
The US Food and Drug Administration granted breakthrough therapy designation for the drug in this indication.
Commenting on the recent data, Immunomedics chief medical officer Loretta Itri said: “This strengthens our resolve to complete the analysis and reporting of the final study results, thereby allowing these data to become available to physicians caring for the TNBC community in a timely fashion.”
FDA is currently reviewing a biologics license application resubmission for the accelerated approval of sacituzumab govitecann to treat mTNBC.
The company is seeking approval for treating patients who had a minimum of two previous therapies for metastatic disease.