Gilead’s Trodelvy Achieves Milestone in Breast Cancer Treatment

In a significant advancement for the treatment of triple-negative breast cancer (TNBC), Gilead Sciences has announced that its antibody-drug conjugate Trodelvy has met its primary endpoint in the late-stage Ascent-03 trial. The trial assessed Trodelvy’s efficacy in previously untreated metastatic TNBC patients who are not candidates for the commonly used PD-1 or PD-L1 inhibitors.

Trodelvy’s Clinical Success

Following its earlier combination success with Keytruda, Trodelvy’s solo performance in the Ascent-03 trial demonstrated a “highly statistically significant and clinically meaningful” improvement in progression-free survival compared to the standard-of-care chemotherapy. The patient cohort specifically included those whose tumors do not express the PD-L1 protein or those who are ineligible for immunotherapy treatment.

Gilead reported that the safety profile of Trodelvy in this trial remained consistent with prior studies, showing no novel safety signals. While overall survival (OS) data, a primary secondary endpoint, is still maturing, Gilead stated that no detriment has been observed thus far.

A Historic Advance in Breast Cancer Care

Gilead’s Chief Medical Officer, Dr. Dietmar Berger, emphasized the significance of the Ascent-03 results, noting that it marks the first clinically meaningful advance in over 20 years for TNBC patients. “By addressing this aggressive and difficult-to-treat disease earlier, we can potentially improve treatment options for the high unmet need that patients with metastatic triple-negative breast cancer face,” he stated.

Position in the Market

Trodelvy’s success follows shortly after its combination therapy with Keytruda in the Ascent-04 trial, where it outperformed both Keytruda and chemotherapy in progression-free survival metrics for TNBC patients with PD-L1-expressing tumors. The detailed results of Ascent-04 will be unveiled at the upcoming American Society of Clinical Oncology meeting.

With data showing efficacy in both PD-L1-positive and PD-L1-negative groups, Gilead’s strategy positions Trodelvy to potentially be the foundational treatment for all patients in the first-line setting of metastatic TNBC.

Competitive Landscape

Despite these achievements, Trodelvy faces escalating competition, particularly from newly approved TROP2 antibody-drug conjugates (ADCs). In January, AstraZeneca and Daiichi Sankyo launched Datroway for HR-positive, HER2-negative breast cancer, while in China, Trodelvy competes against Kelun-Biotech’s partnership with Merck for the Merck-partnered sacituzumab tirumotecan (sac-TMT).

Gilead is not resting on its laurels; it continues to explore Trodelvy’s role in diverse breast cancer populations. The ongoing Ascent-07 study is investigating the drug’s effectiveness in HER2-negative patients who have undergone endocrine therapy, and the Ascent-05 study is focused on early-stage TNBC.

Conclusion

The Ascent-03 trial results underscore Trodelvy’s potential as a game-changer in the realm of breast cancer treatment, especially for those patients with limited options due to specific tumor attributes. As Gilead prepares to present data to regulators and at prominent medical gatherings, the landscape of treatment for metastatic triple-negative breast cancer could be permanently altered in their favor.

With ongoing trials and emerging data, Gilead Sciences is positioning Trodelvy as a cornerstone of comprehensive treatment for patients suffering from this aggressive disease, reinforcing its commitment to addressing unmet medical needs in oncology.