Gilead's Trodelvy achieves key study success in first-line TNBC

Gilead Sciences is making strides in advancing the use of Trodelvy (sacituzumab govitecan-hziy) for treating metastatic triple-negative breast cancer (TNBC). On Friday, the company revealed positive results from a late-stage study, strengthening the case for Trodelvy's role in first-line treatment settings. This follows the recent success of the Phase III ASCENT-04/KEYNOTE-D19 trial, where Trodelvy, in combination with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab), was shown to significantly improve progression-free survival in patients newly diagnosed with PD-L1-positive, inoperable, locally advanced or metastatic TNBC.

Trodelvy's potential has now been further demonstrated in the ASCENT-03 study, which focused on using the drug as a monotherapy. In this study, approximately 540 patients with previously untreated, locally advanced, inoperable, or metastatic TNBC participated. These patients either had tumors not expressing PD-L1 or had PD-L1 positive tumors previously treated with a PD-(L)1 inhibitor in a curative setting. Participants were randomly assigned to receive Trodelvy or a treatment regimen of the physician’s choice, which included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel.

The findings were promising, with Trodelvy achieving the primary endpoint by demonstrating a highly significant and clinically meaningful improvement in progression-free survival compared to chemotherapy. While the key goal of overall survival is not yet mature for analysis, the use of Trodelvy did not show any detriment in outcomes. This suggests Trodelvy could offer substantial benefits for patients battling this aggressive form of breast cancer.

Dietmar Berger, Gilead's chief medical officer, highlighted the significance of the ASCENT-03 study results, noting that this is the first major therapeutic advancement for this patient population in over two decades compared to chemotherapy. The results from ASCENT-03 and ASCENT-04 imply that Trodelvy has the potential to become a fundamental treatment option for all patients with first-line metastatic TNBC.

Further details from the ASCENT-04 trial will be disclosed at the upcoming American Society of Clinical Oncology (ASCO) annual meeting, where the medical community will learn more about the implications of these findings.

Trodelvy is already sanctioned for use in second-line or later settings for metastatic TNBC and is also approved for certain patients with pre-treated HR-positive/HER2-negative metastatic breast cancer. With the encouraging results from these studies, Gilead Sciences is optimistic about the role of Trodelvy in transforming the treatment landscape for TNBC patients, offering new hope where few options previously existed.

As research and clinical trials continue, Trodelvy's expanding role in breast cancer treatment underscores Gilead Sciences' commitment to improving outcomes for patients facing challenging diagnoses and providing innovative therapies that address unmet needs in oncology.