Trodelvy Shows Positive Results for Patients With Metastatic Breast Cancer
New TROPiCS-02 data for Gilead treatment demonstrates progression-free survival benefit, regardless of HER2 status.
Results of the TROPiCS-02 trial demonstrated that sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences) improved median progression free survival (PFS) compared with the physician’s choice of chemotherapy for individuals with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative, breast cancer who progressed on endocrine-based therapies and at least 2 chemotherapies.
Investigators examined the PFS in the intention-to-treat population by HER2-immunohistorchemistry (IHC) status.
“These results show [sacituzumab govitecan-hziy] improved [PFS], regardless of HER2 status in this pre-treated patient population, and reinforce the strength of clinical activity in a population where need is highest,” Bill Grossman, MD, PhD, senior vice president of therapeutic area head at Gilead Oncology, said in a statement.
In individuals with HER2-low breast cancer, the median PFS was 6.4 months for those in the sacituzumab govitecan-hziy arm and 4.2 for the physician’s choice chemotherapy. In individuals with IHC0 breast cancer the median PFS was 5 months and 3.4, respectively.
Additionally, in the intent-to-treat population, the median PFS was 5.5 months and 4 months, respectively.
“These data demonstrate [sacituzumab govitecan-hziy]’s efficacy across HER2-low and IHC0 status in pre-treated metastatic breast cancer patients in the TROPiCS-02 trial,” Peter Schmid, director of the Barts Breast Cancer Centre, said in the statement.
“Once patients have developed resistance to endocrine-based therapies, their prognosis is extremely poor,” Schmid said. “The results highlight the potential for [sacituzumab govitecan-hziy] as a treatment option for people living with pre-treated HR+/HER2- metastatic breast cancer, regardless of their HER2-negative status.”
Investigators defined HER2 negativity as an IHC score of 0, IHC 1+, or IHC 2+ with a negative in-situ hybridization test, according to the American Society of Clinical Oncology and College of American Pathologist criteria.
Sacituzumab govitecan-hziy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer, and its efficacy and safety for this indication have not been established.
Investigators included 543 individuals who were previously treated with endocrine therapy, CDK4/6 inhibitors and 2 to 4 lines of chemotherapy for metastatic disease. The physician’s choice of chemotherapy included capecitabine, eribulin, gemcitabine, or vinorelbine.
Gilead has submitted a supplemental biologics license application to the FDA based on data from the TROPiCS-02 trial.
The data will also be shared with health authorities outside the United States.
Detailed results will be presented at a mini-oral session during the European Society for Medical Oncology Congress 2022 on September 10, 2022.
Sacituzumab govitecan is included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, including a category 1 recommendation for use in adults with second-line metastatic triple-negative breast cancer, defined as at least 2 prior therapies with at least 1 line for metastatic disease.
The box warning includes adverse events of severe or life-threatening neutropenia as well as severe diarrhea.
Additionally, it also has a category 2A preferred recommendation for the investigational use in HR+/HER2- advanced breast cancer after prior treatment including endocrine therapy, a CDK4/6 inhibitor and at least 2 lines of chemotherapy.
New TROPiCS-02 data in HR+/HER2- metastatic breast cancer patients demonstrates progression-free survival benefit of Trodelvy regardless of their HER2 status. News release. Gilead. September 4, 2022. Accessed September 6, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/9/new-tropics02-data-in-hrher2-metastatic-breast-cancer-patients-demonstrates-progressionfree-survival-benefit-of-trodelvy-regardless-of-their-her