Immunomedics Inc. (NASDAQ:IMMU) confirmatory third phase ASCENT study of Trodelvy met both the primary progression-free survival endpoint and the secondary endpoints in the previously treated brain metastasis negative mTNBC patients.
Immunomedics reports encouraging Phase 3 ASCENT study data
The study’s lead investigator, Aditya Bardia, stated that the results from the Phase 3 ASCENT study affirmed preliminary observations that Trodelvy has the potential of changing mTNBC’s standard management. Bardia added that the Trodelvy study’s data set a benchmark in clinical and scientific innovation for mTNBC patients. This is by offering a proprietary treatment alternative to the current clinical practice therapies for metastatic disease. Most importantly, the top-line ASCENT data also confirms a manageable safety profile of Trodelvy, making it a good combination candidate with other therapies.
Data from the study indicate that the drug showed significant improvement statistically in the primary PFS endpoint relative to chemotherapy. Equally, the drug met key secondary endpoints like objective response rate and overall survival rate. The reported safety profile was consistent with the FDA-approved label with diarrhea and neutropenia, the only common adverse effects with no new safety signals reported. Immunomedics is planning to present the full results of the ASCENT study at an upcoming medical summit.
Trodelvy approved by FDA for mTNBC treatment
Loretta Itri, the company’s Chief Medical Officer, indicated that considering the poor prognosis related to mTNBC, they were delighted that Trodelvy showed enhanced clinical outcomes in the subjects. Itri acknowledged the company’s efforts to overcome the COVID-19 restrictions and completed the collection and analysis of data in time. She added that Immunomedics will be sharing the data with the FDA to support the approval of Trodelvy in the treatment of mTNBC.
The FDA recently approved the drug as a third-line treatment for mTNBC patients under the Accelerated Approval program. The approval was based on the duration of response and objective response rate observed in Phase 2 multicentre study. Phase 3 ASCENT study was designed under the FDA’s Special Protocol Assessment for validation of efficacy and safety of Trodelvy.