Recently, the FDA granted regular approval to sacituzumab govitecan (Trodelvy®, Immunomedics, Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously been treated with two or more systemic therapies, at least one of them for metastatic disease. The FDA had previously granted accelerated approval to sacituzumab govitecan based on the results of the phase 1/2 IMMU-132-01 study (NCT01631552); the phase 3 ASCENT study (NCT02574455), on which the regular approval was based, was initiated to confirm those results. In this interview, the lead author of ASCENT, Aditya Bardia, MD, MPH, of Massachusetts General Hospital Cancer Center, speaks with Oncology Data Advisor about sacituzumab govitecan for TNBC.
What additional insights into sacituzumab govitecan's efficacy and safety were gained from the ASCENT trial, which led to the FDA's granting of regular approval?
Aditya Bardia, MD, MPH: Previously, the FDA had provided accelerated approval to sacituzumab govitecan for treatment of patients with metastatic TNBC who had received at least two prior therapies, based on results of a single-arm phase 2 study. The accelerated approval was contingent on the results of the confirmatory randomized phase 3 trial (ASCENT). The ASCENT trial randomized patients with metastatic TNBC to sacituzumab govitecan versus standard chemotherapy of physician choice (eribulin, gemcitabine, capecitabine, vinorelbine). The study results, as provided in the FDA press release, demonstrated that sacituzumab govitecan was associated with a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival), extending median progression-free survival to 4.8 months from 1.7 months with chemotherapy (HR=0.43 [95% CI: 0.35-0.54]; P<0.0001). In addition, sacituzumab govitecan extended median overall survival to 11.8 months versus 6.9 months (HR=0.51 [95% CI: 0.41-0.62]; P<0.0001), representing a 49% reduction in the risk of death.
What should oncologists treating patients with TNBC consider when deciding between sacituzumab govitecan and other therapy options?
Dr. Bardia: As compared with standard chemotherapy (eribulin, gemcitabine, capecitabine, vinorelbine), sacituzumab govitecan was associated with improvement in both progression-free survival and overall survival.
What are the most significant adverse events associated with sacituzumab govitecan, and how can clinicians best manage them?
Dr. Bardia: The most common adverse effects with sacituzumab govitecan include myelosuppression, diarrhea, and alopecia. The adverse events can be managed with dose interruption, dose reduction, and supportive management.
What unmet needs still exist in this patient population?
Dr. Bardia: Sacituzumab govitecan was approved for patients with pretreated metastatic TNBC, and there is a need for development of therapies in earlier lines of therapy, including localized breast cancer, to prevent metastasis.
About Dr. Bardia
Aditya Bardia, MD, MPH, is a medical oncologist who treats patients with breast cancer at Massachusetts General Hospital in Boston, MA. Dr. Bardia's interests include developing successful targeted and personalized therapies to improve outcomes for patients with breast cancer. He is the principal investigator of clinical trials that aim to investigate targeted therapy combinations that may prove beneficial in breast cancer. Dr. Bardia was the 2010 recipient of the Young Investigator Award from the American Society of Clinical Oncology (ASCO) Conquer Cancer Foundation.
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Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.