Gilead Sciences (Gilead) has announced positive results from a phase 3 study evaluating Trodelvy (sacituzumab govitecan-hziy) in pre-treated hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer patients.
The phase 3 TROPiCS-02 study demonstrated ‘statistically significant and clinically meaningful’ results from the second interim analysis of the key secondary endpoint of overall survival in patients who had received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Detailed OS results will be presented at an upcoming medical conference, the company said.
Additionally, the safety profile for Trodelvy was consistent with prior studies, and no new safety signals were observed. Gilead has submitted a supplemental Biologics Licence Application to the US Food and Drug Administration (FDA).
HR+/HER2- breast cancer is the most common type of breast cancer, accounting for around 70% of all new cases, or nearly 400,000 diagnoses worldwide each year. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%, Gilead reported.
As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy.
Commenting on the positive results, Merdad Parsey, chief medical officer, Gilead Sciences, said: “The survival results from the TROPiCS-02 study are important for the breast cancer community and we are encouraged by the potential this may have in helping patients who otherwise have limited alternatives.
“We look forward to discussing the results with global health authorities, as pre-treated HR+/HER2- metastatic disease patients currently have limited treatment options and poor quality of life.”
Following the positive data, the company also announced an agreement with Everest Medicines to transfer all development and commercialisation rights to Gilead for Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.
Under the terms of the agreement, Gilead will make a $280m upfront payment to Everest, who is eligible to receive up to $175m in potential milestones.
Bill Grossman, senior vice president, oncology clinical research, Gilead Sciences, said: “Trodelvy is the cornerstone of our solid tumour portfolio, and we are committed to bringing this transformative therapy to as many patients as possible. We look forward to rapidly advancing our development programme in Asia and to realising the clinical potential of Trodelvy across diverse tumour types.”