Sacituzumab Govitecan Obtains European Approval For HR+/HER2– Breast Cancer

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The approval from the European Commission is based on findings from the phase 3 TROPiCS-02 study.

The FDA approved sacituzumab govitecan for hormone receptor–positive, HER2-negative breast cancer in February 2023.

The FDA approved sacituzumab govitecan for hormone receptor–positive, HER2-negative breast cancer in February 2023.

The European Commission has approved single-agent sacituzumab govitecan-hziy (Trodelvy) for the treatment of patients with unresectable or metastatic, hormone receptor (HR)–positive, HER2-negative breast cancer who underwent endocrine-based therapy and 2 or more additional systemic therapies in the advanced setting, according to a press release from Gilead Sciences, Inc.1

The approval took place based on findings from the phase 3 TROPiCS-02 study (NCT03901339). Sacituzumab govitecan yielded a median overall survival (OS) of 14.4 months vs 11.2 months with physician’s-choice treatment (HR, 0.79; 95% CI, 0.65-0.96; P = .02). The median progression-free survival (PFS) with sacituzumab govitecan was 5.5 months vs 4.0 months with physician’s choice (HR, 0.66; 95% CI, 0.53-0.83; P = .0003). At 1 year, 21% of those treated with the experimental agent were progression-free compared with 7% of those treated with physician’s choice.

Other findings from the final overall survival (OS) analysis of the TROPiCS-02 study were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.2 In the experimental and control arms, respectively, the 12-month OS rates were 60.9% (95% CI, 54.8%-66.4%) vs 47.1% (95% CI, 41.0%-53.0%), the 18-month rates were 39.2% (95% CI, 33.4%-45.0%) vs 31.7% (95% CI, 26.2%-37.4%), and the 24-month rates were 25.7% (95% CI, 20.5%-31.2%) vs 21.1% (95% CI, 16.3%-26.3%).

"The European approval of sacituzumab govitecan is an important milestone for the European breast cancer community,” Javier Cortes, MD, head of the International Breast Cancer Center in Madrid and Barcelona, said in the press release.1 “We now have a new treatment option that has delivered a proven and clinically meaningful survival benefit for women in Europe with pre-treated [HR-positive/HER2-negative] metastatic breast cancer.”

No new safety signals associated with sacituzumab govitecan were identified during the trial.1 The most common serious adverse effects (AEs) were diarrhea (5%), febrile neutropenia (4%), and neutropenia (3%). There were no instances of interstitial lung disease, and the discontinuation rates due to AEs were 6% and 4% in the experimental and control arms, respectively.

Sacituzumab govitecan was approved by the FDA in this disease space in February 2023.3

References

  1. European Commission approves Gilead’s Trodelvy® for pre-treated HR+/HER2- metastatic breast cancer. News Release. Gilead Sciences, Inc. July 27, 2023. Accessed July 31, 2023. https://bit.ly/3DDBOww
  2. Tolaney SM, Bardia A, Marmé F, et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC). J Clin Oncol. 2023;41(suppl 16):1003. doi:10.1200/JCO.2023.41.16_suppl.1003
  3. U.S FDA approves Trodelvy in pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead Sciences, Inc. February 3, 2023. Accessed July 31, 2023. https://bwnews.pr/3Y0bftX
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