Gilead drug cuts disease progression in commonest type of breast cancer
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Announcing data from a Phase 3 study, Gilead (NASDAQ:GILD) said on Saturday that its antibody-drug conjugate Trodelvy delayed the disease progression by 1.5 months in a group of patients with heavily pre-treated HR+/HER2- metastatic breast cancer compared to chemotherapy.
The 543-patient trial was designed to evaluate the effect of Trodelvy in HR+/HER2- metastatic breast cancer, the most common type of breast cancer. The patients were previously treated with endocrine therapy and up to four lines of chemotherapy.
The data from the primary analysis as presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting indicated 5.5 months of median progression-free survival (the duration a person lives without the disease worsening) for patients who received Trodelvy.
Meanwhile, those who received chemotherapy (TPC) demonstrated a median progression-free survival of 4 months (HR: 0.66; 95% CI: 0.53-0.83; P<0.0003).
Overall survival, the secondary endpoint of the trial, indicated a positive trend in the first interim analysis. However, the data were immature, Gilead (GILD) said, adding that a subsequent analysis for OS â the âgold standardâ for measuring the clinical benefits of a cancer drug â would be conducted.
Trodelvy, also known as sacituzumab govitecan-hziy, is already approved in the U.S. for certain patients with triple-negative breast cancer and urothelial cancer, a type of bladder cancer.
In the multinational, open-label TROPiCS-02 study, the drug was found to have a safety profile consistent with prior studies. Neutropenia (51% versus 38%) and diarrhea (9% versus 1%) were among the most frequent Grade â¥3 treatment-related adverse reactions, the company said.
In March, Gilead (GILD) announced that the trial met the primary endpoint of PFS with a statistically significant improvement compared to chemotherapy. However, the company shares slipped amid concerns over the lack of detailed results.