FDA Grants Priority Review to Sacituzumab Govitecan-hziy in HR+/HER2– Advanced Breast Cancer

Article

Based on results from the phase 3 TROPiCS trial, the FDA has granted priority review to sacituzumab govitecan-hziy for unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer.

The FDA has granted priority review to sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have previously received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting, according to a press release from Gilead.1

The priority review is based on results from the phase 3 TROPiCS-02 trial (NCT03901339) analyzing sacituzumab govitecan vs chemotherapy in patients previously treated with endocrine therapy, a CDK 4/6 inhibitor, and 2 to 4 lines of chemotherapy.2 The agent resulted in a 34% reduction in risk of progression or death, with a median progression-free survival of 5.5 months (95% CI, 4.2-7.0) in the sacituzumab arm vs 4.0 months (95% CI, 3.1-4.4) in the chemotherapy arm (HR, 0.789; 95% CI, 0.646-0.964; P = .02).

The Prescription Drug User Fee Act date has been set for February 2023.

“[Sacituzumab govitecan] has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last 2 years,” Bill Grossman, MD, PhD, senior vice president and Therapeutic Area Head of Gilead Oncology, said in the press release. “People with pre-treated hormone receptor–positive/HER2-negative metastatic breast cancer who have progressed on endocrine-based therapies and chemotherapy have limited treatment options, and we look forward to working with the FDA to potentially make [sacituzumab govitecan] available to patients who need it most.”

A total of 543 patients were enrolled in the trial and were randomly assigned 1:1 to receive 10 mg/kg of sacituzumab (n = 271) intravenously on days 1 and 8 of each cycle, or physician's choice chemotherapy (n = 271).

The median overall survival was 13.9 months (95% CI, 12.7-15.4) in the sacituzumab arm and 12.3 months (95% CI, 10.8-14.2) in the chemotherapy arm (HR, 0.84; 95% CI, 0.67-1.06; P = .14). In the sacituzumab arm, the objective response rate was 21.0% vs 14.0% in the chemotherapy arm (P = .03). Moreover, treatment with sacituzumab govitecan resulted in a median duration of response of 7.4 months (95% CI, 6.5-8.6) vs 5.6 months (95% CI, 3.8-7.9).

Patients most commonly discontinued treatment in the sacituzumab govitecan arm because of progressive disease (n = 210), adverse effects (n = 18), consent withdrawal (n = 8), treatment delay by over 3 weeks (n = 5), other reasons (n = 5), death (n = 3), and protocol deviation (n = 1). Of note, 18 patients continued treatment. In the chemotherapy arm, discontinuation occurred because of progressive disease (n = 197), consent withdrawal (n = 22), AEs (n = 11), other reasons (n = 6), protocol deviation (n = 3), COVID-19 (n = 3), death (n = 2), and treatment delay of more than 3 weeks (n = 1); four patients remained on treatment.

Treatment-emergent adverse effects (TEAEs) of grade 3 or higher occurred in 74% of patients in the sacituzumab arm and 60% in the chemotherapy arm. Discontinuations due to TEAEs in the sacituzumab govitecan and chemotherapy arms, respectively, occurred in 6% vs 4%, dose delay in 66% vs 44%, and dose reduction in 33% vs 33%. Additionally, serious TEAEs were observed in 28% of patients in the sacituzumab arm vs 19% in the chemotherapy arm, and 2% vs 0% had TEAEs leading to death, respectively.

References

  1. U.S. FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy® for pre-treated HR+/HER2- metastatic breast cancer. News Release. Gilead. October 11, 2022. Accessed October 11, 2022. https://bit.ly/3EyYMH5
  2. 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

Related Videos
Barbara Smith, MD, PhD, spoke about the potential use of pegulicianine-guided breast cancer surgery based on reports from the phase 3 INSITE trial.
Carey Anders, MD, an expert on breast cancer
Carey Anders, MD, an expert on breast cancer
Carey Anders, MD, an expert on breast cancer
Carey K. Anders, MD, an expert on breast cancer
A panel of 4 experts on breast cancer seated at a long table
A panel of 4 experts on breast cancer seated at a long table
A panel of 4 experts on breast cancer seated at a long table
Related Content