Hope S. Rugo, MD, FASCO, spoke about future analyses of the phase 3 TROPiCS-02 trial that examined sacituzumab govitecan vs physicians’ choice chemotherapy in patients with hormone receptor–positive, HER2-negative advanced breast cancer.
At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork® spoke with Hope S. Rugo, MD, FASCO, director of Breast Oncology and Clinical Trials Education and professor of medicine in the Division of Hematology and Oncology at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, about additional research surrounding the phase 3 TROPiCS-02 trial (NCT03901339) which is looking at sacituzumab govitecan-hziy (Trodelvy) vs physicians’ choice chemotherapy for patients with hormone receptor–positive, HER2-negative advanced breast cancer. She mentioned efficacy of the regimen in patients with HER2-low breast cancer, who might derive benefit from its use. Future presentations will clarify the overall survival benefit of treatment, as there were not enough data at the time of presentation.
For TROPiCS-02, there are additional plans for [more research]. Obviously, we can look at the HER2-low population, which now has become a group where we will have, in the very near future, a treatment option in the second and third lines, or earlier line therapy, with trastuzumab deruxtecan from the DESTINY-Breast04 trial [NCT03734029]. This is very exciting and a highly effective agent in this setting, but that’s an earlier line. It’s helpful to know that in 65% of patients with hormone receptor–positive disease, how many were HER2-low in TROPiCS-02 and how did they do? That’s one analysis.
There are many analyses planned on different biologic- and treatment-related aspects, for example in patients who’ve received prior capecitabine or not. One important secondary end point is overall survival. In the first interim analysis, we didn’t have enough events and there was no significant difference [between treatment arms], but 2 additional analyses are planned. We’ll look for that as well. Then there are other studies looking at sacituzumab govitecan in triple-negative and hormone receptor–positive diseases in combination with checkpoint inhibitors. There’s a post-neoadjuvant trial in high-risk hormone receptor–positive and triple-negative disease being run by the German breast group. [Finally, there is] a neoadjuvant study that started [by examining] sacituzumab govitecan alone and now assessed sacituzumab govitecan and a checkpoint inhibitor.
Rugo HS, Bardia A, Marme F, et al. Primary results from TROPiCS-02: A randomized phase 3 study of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (Pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer. J Clin Oncol. 2022;40(suppl 17):LBA1001. doi: 10.1200/JCO.2022.40.17_suppl.LBA1001