Gilead has announced full results from its study of Trodelvy (sacituzumab govitecan) plus Keytruda (pembrolizumab) as a first-line treatment for patients with metastatic triple-negative breast cancer (TNBC). The results were published in The New England Journal of Medicine.
The phase 3 ASCENT-04/KEYNOTE-D19 study evaluated the treatment combination’s efficacy and safety in patients with locally advanced or metastatic TNBC whose tumours express programmed death-ligand 1 (PD-L1). The trial met its primary endpoint of progression-free survival (PFS), demonstrating a 35% reduced risk of progression or death in patients treated with Trodelvy-Keytruda compared to those receiving Keytruda and chemotherapy, which is the current standard of care.
The median PFS for the Trodelvy-Keytruda group was 11.2 months, whereas in the Keytruda-chemotherapy group, it was 7.8 months.
The researchers did not observe any new safety signals or find that combining Trodelvy and Keytruda affected the individual safety profile of either. Only 12% of patients in the Trodelvy-Keytruda arm of the study discontinued treatment because of adverse events, compared to 31% in the Keytruda-chemotherapy arm.
Trodelvy has an established profile in breast cancer treatment. Over the past five years, over 60,000 breast cancer patients have received Trodelvy in more than 50 countries.
Gilead has also submitted supplemental applications to the US FDA and the EMA for Trodelvy has a monotherapy in TNBC patients who cannot be treated with PD-1/PD-L1 inhibitors.
Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and principal investigator of the study, said: “This very promising data with the novel combination of sacituzumab govitecan and pembrolizumab in frontline metastatic TNBC represents a meaningful step forward in establishing a potential new standard of care for this challenging disease.”
Dietmar Berger, Chief Medical Officer at Gilead, added: “Metastatic TNBC patients often show rapid progression and poor outcomes after current first-line therapies, illustrating the urgent need for new and more efficacious treatment options.
“These results represent important progress toward our goal of delivering Trodelvy to patients in earlier lines of breast cancer treatment, with potential to become a backbone therapy for all frontline metastatic TNBC patients in need of innovative therapeutics.”