#USA #Foster City #Gilead #Trodelvy #ASCENT-07

Gilead's ASCENT-07 Trial Data Release

On November 7, Gilead Sciences (located in Foster City, California, and traded on NASDAQ under the ticker GILD) announced the results from its Phase III ASCENT-07 trial. This study aimed to compare the efficacy of Trodelvy (sacituzumab govitecan) against chemotherapy as a first-line treatment for patients with metastatic or recurrent hormone receptor-positive and HER2-negative (HR+/HER2-) breast cancer following endocrine therapy. The results indicated that the primary endpoint, progression-free survival (PFS), as measured through blinded independent central review (BICR) using RECIST v1.1 criteria, was not achieved.

However, favorable trends were observed in secondary endpoints, particularly overall survival (OS), although this data remains immature as of the time of the primary analysis. Dr. Hope S. Rugo, who is the chief of breast oncology and director of the gynecologic cancer program at City of Hope Comprehensive Cancer Center, and the principal investigator of the ASCENT-07 trial remarked on the complexity and heterogeneity of HR+/HER2- breast cancer, emphasizing the need for tracking OS to understand the long-term potential impacts of sacituzumab govitecan on this treatment landscape.

Dr. Dietmar Berger, Chief Medical Officer at Gilead, acknowledged the significance of the prior results from the TROPiCS-02 trial that showed OS improvements, stating that Trodelvy has now become the standard treatment for patients with treatment history of metastatic or recurrent HR+/HER2- breast cancer. He expressed gratitude towards the participants and their families for their contributions to this critical research and hinted at plans for full data presentation at upcoming scientific meetings.

Trodelvy has been recognized globally for its efficacy, showing an OS extension in both treated metastatic HR+/HER2- breast cancer and in cases of metastatic recurrent triple-negative breast cancer (TNBC). It has recently received Category 1 recommendation in the National Comprehensive Cancer Network (NCCN) treatment guidelines and is the only antibody-drug conjugate (ADC) rated 5 under the ESMO Magnitude of Clinical Benefit Scale for metastatic recurrent TNBC.

The ASCENT-07 trial enrolled 654 patients across about 30 countries and was designed to evaluate the safety and efficacy of sacituzumab govitecan compared to physician's choice chemotherapy. Patients were randomized to receiveTrodelvy or standard chemotherapy, which included agents like capecitabine or paclitaxel, with treatment continuing until disease progression or unacceptable toxicity.

As Trodelvy’s safety profile aligns with previous findings, no new safety concerns were identified in this patient population. However, it has not yet been established that Trodelvy is safe and effective as a first-line treatment after endocrine therapy for HR+/HER2- breast cancer or for first-line treatment in metastatic TNBC.

The ASCENT-07 trial revealed that HR+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases globally, with around 400,000 diagnoses each year. While endocrine therapy has contributed to prolonged survival, nearly all patients eventually show disease progression, highlighting the urgent need for more effective and tolerable treatment options.

Gilead remains optimistic about Trodelvy’s potential in a broader clinical setting, with ongoing development programs including the Phase III ASCENT-05 trial targeting early-stage high-risk TNBC and additional trials assessing its applications in lung and gynecological cancers.

As Gilead continues to address the treatment needs of HR+/HER2- breast cancer and TNBC, the company is committed to bettering outcomes for patients through innovative research and collaboration. As it builds upon ASCENT-07 results and investigates Trodelvy in diverse stages and types of cancer, there is much anticipation for what these studies will reveal in the future.