Trodelvy Shows Significant PFS Improvement for TNBC Treatment

Trodelvy's Promising Results in Treating Triple-Negative Breast Cancer

In a recent announcement, Gilead Sciences reported significant findings from the Phase III ASCENT-03 trial, revealing that Trodelvy (sacituzumab govitecan) has achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with metastatic or recurrent triple-negative breast cancer (TNBC) who did not qualify for treatment with PD-1/PD-L1 inhibitors. This trial primarily focused on patients as initial treatment options for TNBC, marking a crucial milestone in addressing a pressing medical need.

Dr. Javier Cortes, the lead investigator and director at the International Breast Cancer Center in Spain, emphasized the urgent need for innovative options in early treatment for nearly half of the TNBC patients who cannot receive subsequent treatment after their primary therapy. Historically, chemotherapies have been the mainstay of treatment; however, the ASCENT-03 findings signal potential advancements that could address a significant unmet need for patients and the broader oncology community.

The ASCENT-03 trial included a total of 540 participants across various global sites. It assessed the efficacy and safety of Trodelvy compared to traditional physician-chosen treatment regimens (TPC) involving chemotherapeutic agents such as gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Significantly, Trodelvy emerged as the first antibody-drug conjugate (ADC) with the potential to become a fundamental agent for all patients undergoing first-line treatment for metastatic or recurrent TNBC.

Furthermore, the recent positive outcomes of the ASCENT-04 trial, which evaluated Trodelvy in combination with Keytruda (pembrolizumab) for previously untreated PD-L1 positive TNBC patients, reiterate the drug’s capacity to serve as the cornerstone therapy for this patient group. Detailed results from the ASCENT-04 trial are scheduled to be presented at the American Society of Clinical Oncology (ASCO) annual meeting from May 30 to June 3, 2025.

Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead, noted that the results from ASCENT-03 highlight the first clinically meaningful advancement against chemotherapy for this patient demographic in over 20 years. The focus on early intervention presents a significant opportunity to improve treatment options for patients grappling with the high unmet needs of metastatic or recurrent TNBC.

The safety profile of Trodelvy in ASCENT-03 aligned with previous studies, showing no new safety signals in this patient population. However, the overall survival (OS) data remains immature at the time of the PFS analysis, prompting Gilead to continue monitoring these patients and conduct additional analyses for OS outcomes. Further results from the ASCENT-03 trial are set to be shared with regulatory bodies for examination.

Trodelvy’s role in clinical practice is already established, with over 60,000 patients treated across more than 50 countries in clinical trials and real-world studies over the last five years, demonstrating consistent results. The drug is the only ADC to have yielded favorable results in four Phase III trials focused on metastatic or recurrent HER2-negative (IHC scores 0, 1+, or 2+/ISH negative) breast cancer, approved for its significant survival extensions in both metastatic recurrent TNBC and treatment-experienced hormone receptor-positive (HR+/HER2-) breast cancer.

Trodelvy is currently recommended as a Category 1 treatment option under the National Comprehensive Cancer Network (NCCN) guidelines for both approved indications, receiving the highest score of 5 on the ESMO Magnitude of Clinical Benefit Scale for metastatic or recurrent TNBC. For patients with metastatic or recurrent HR+/HER2- breast cancer, Trodelvy is rated at 4.

Gilead is actively conducting additional studies in various stages of breast cancer, including the ASCENT-07 and ASCENT-05 trials targeting patients with HR+/HER2- breast cancer following endocrine therapy, and early-stage TNBC, respectively. Other Phase III trials are also assessing Trodelvy in different malignancies, like lung cancer and gynecological cancers.

In conclusion, Gilead extends gratitude to the patients, families, investigators, and supporters contributing to this critical research effort. The company remains committed to addressing the unmet needs of breast cancer patients through continued advancements in care.

Trodelvy is a registered trademark of Gilead Sciences, Inc.