None of the patients taking sacituzumab govitecan-hziy experienced grade 2 or higher neuropathy or grade 3 or higher interstitial lung disease, and no treatment-related deaths occurred in this arm. Those that reached grade 3 or higher in the 2 arms included neutropenia (46% in the experimental arm and 27% in the control arm), diarrhea (10% and <1%, respectively), and leukopenia (10% and 5%, respectively). Of these patients, 10 in the experimental arm achieved a complete response vs 2 in the control arm 72 vs 9, respectively, achieved a partial response.Īdverse events proved to be manageable in the ASCENT trial. The ORR among patients who were negative for brain metastases was 7 times greater among those who received sacituzumab govitecan-hziy vs those who received chemotherapy: 35% (82 patients) vs 5% (11 patients). OS was also significantly improved among the patients taking the experimental drug: 12.1 months with sacituzumab govitecan-hziy (range, 10.7–14.0) vs 6.7 months with standard treatment (range, 5.8-7.7). 6 The median PFS was 5.6 months (range, 4.3-6.3) among the patients receiving sacituzumab govitecan-hziy and 1.7 months (range, 1.5-2.6) among those receiving physician’s choice of treatment. Standard treatment consisted of one of the following: eribulin, vinorelbine, gemcitabine, or capecitabine. 5 A total of 529 patients were enrolled in the study, with 267 randomized to the experimental arm and 262 randomized to the standard treatment arm. The trial was stopped early because of the efficacy of the experimental drug. The secondary endpoints included PFS for all patients, including those with or without brain metastases, along with overall survival (OS), overall response rate (ORR), time to response, duration of response, and safety. The primary endpoint was progression-free survival (PFS). 5 The phase 3 confirmatory study, ASCENT, compared sacituzumab govitecan-hziy with physician’s choice of treatment in patients with metastatic TNBC who had received at least 2 prior chemotherapy regimens for advanced disease. The FDA granted sacituzumab govitecan-hziy accelerated approval for metastatic triple-negative breast cancer (TNBC) in April 2020 on the basis of a single-arm, multicenter study of 108 patients. ![]() 1,2 This ADC differs from others in its high degree of specificity for Trop-2 as well as its high drug-to-antibody ratio. Sacituzumab govitecan-hziy is the first antibody-drug conjugate (ADC) directed against Trop-2, an antigen expressed in all breast cancer subtypes and linked to poor prognosis. A Review of Selected Presentations From the 2020 SABCS Virtualīiomarker Evaluation in the Phase 3 ASCENT Study of Sacituzumab Govitecan vs Chemotherapy in Patients With Metastatic Triple-Negative Breast Cancer
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