Gilead and Kite Strengthen Cancer Treatment Innovations Ahead of ESMO 2025
Gilead Sciences, headquartered in Foster City, California, and Kite, based in Santa Monica, California, are preparing to present significant new data at the upcoming ESMO 2025 Annual Congress, which will take place from October 17 to 21. Their presentations will focus on innovative approaches to cancer treatment, particularly highlighting advancements in therapies for triple-negative breast cancer (TNBC) and advanced gastric cancer.
One of the key highlights will be the presentation of the latest results from the Phase III ASCENT-03 trial, which pertains to Trodelvy (sacituzumab govitecan) in the context of first-line treatment for metastatic and relapsed TNBC patients who are unsuitable for PD-1/PD-L1 inhibitors. The recent data demonstrate that Trodelvy has shown a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard chemotherapy, indicating a possible redefinition of the first-line treatment landscape for these patients. This groundbreaking progress reflects two decades of research since the classification of TNBC as a distinct disease entity.
Following this, new findings from the ASCENT-04/KEYNOTE-D19 trial will also be presented, evaluating combination therapy involving Trodelvy and Keytruda (pembrolizumab) against results from patients receiving Keytruda with chemotherapy. The goal will be to assess the quality of life among participants in these respective treatments. Earlier results from this trial were announced in late-breaking sessions at the 2025 ASCO annual meeting.
While Trodelvy combined with Pembrolizumab is currently in development for PD-L1 positive metastatic and relapsed TNBC, the standalone Trodelvy therapy for patients unsuitable for PD-1/PD-L1 inhibitors remains under investigation, with its efficacy and safety not yet established. Gilead's Chief Medical Officer, Dr. Dietmar Berger, reiterated the importance of these findings, suggesting that Trodelvy could potentially become a standard treatment option for all TNBC patients, irrespective of PD-L1 expression status.
In collaboration with Arcus Biosciences, Gilead will also reveal results from the Phase II EDGE-Gastric trial focused on patients with unresectable or metastatic gastric or esophageal cancer. This trial evaluates the efficacy of a new combination regimen that includes Domvanalimab, an anti-TIGIT antibody, and Zimberelimab, an anti-PD-1 monoclonal antibody along with chemotherapy. Preliminary data from this trial showed a median overall survival (OS) of 26.7 months, along with a remarkable finding that 50% of patients had a survival exceeding two years.
The safety profile of this combination therapy appears to be tolerable overall, with reports of immune-mediated adverse events occurring in 22% of participants; however, the data is still under analysis and the safety and efficacy have yet to be conclusively established.
The abstracts accepted for presentation at ESMO 2025 include:
As Gilead and Kite continue their efforts within oncology, the introduction of innovative therapies such as Trodelvy, Domvanalimab, and Zimberelimab underscore the companies’ commitment to addressing treatment gaps for diverse cancer types. Gilead has been at the forefront of biopharmaceutical innovation for over 30 years, aiming to create a healthier world through medical advancements against life-threatening diseases.
Innovative Findings in Triple-Negative Breast Cancer Treatment
One of the key highlights will be the presentation of the latest results from the Phase III ASCENT-03 trial, which pertains to Trodelvy (sacituzumab govitecan) in the context of first-line treatment for metastatic and relapsed TNBC patients who are unsuitable for PD-1/PD-L1 inhibitors. The recent data demonstrate that Trodelvy has shown a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard chemotherapy, indicating a possible redefinition of the first-line treatment landscape for these patients. This groundbreaking progress reflects two decades of research since the classification of TNBC as a distinct disease entity.
Following this, new findings from the ASCENT-04/KEYNOTE-D19 trial will also be presented, evaluating combination therapy involving Trodelvy and Keytruda (pembrolizumab) against results from patients receiving Keytruda with chemotherapy. The goal will be to assess the quality of life among participants in these respective treatments. Earlier results from this trial were announced in late-breaking sessions at the 2025 ASCO annual meeting.
While Trodelvy combined with Pembrolizumab is currently in development for PD-L1 positive metastatic and relapsed TNBC, the standalone Trodelvy therapy for patients unsuitable for PD-1/PD-L1 inhibitors remains under investigation, with its efficacy and safety not yet established. Gilead's Chief Medical Officer, Dr. Dietmar Berger, reiterated the importance of these findings, suggesting that Trodelvy could potentially become a standard treatment option for all TNBC patients, irrespective of PD-L1 expression status.
Expanding Impact on Gastric and Esophageal Cancer Treatments
In collaboration with Arcus Biosciences, Gilead will also reveal results from the Phase II EDGE-Gastric trial focused on patients with unresectable or metastatic gastric or esophageal cancer. This trial evaluates the efficacy of a new combination regimen that includes Domvanalimab, an anti-TIGIT antibody, and Zimberelimab, an anti-PD-1 monoclonal antibody along with chemotherapy. Preliminary data from this trial showed a median overall survival (OS) of 26.7 months, along with a remarkable finding that 50% of patients had a survival exceeding two years.
The safety profile of this combination therapy appears to be tolerable overall, with reports of immune-mediated adverse events occurring in 22% of participants; however, the data is still under analysis and the safety and efficacy have yet to be conclusively established.
Summary of ESMO 2025 Presentations
The abstracts accepted for presentation at ESMO 2025 include:
- - ASCENT-03 trial results for Trodelvy in untreated metastatic TNBC (#LBA20) on October 19.
- - ASCENT-04 trial outcomes comparing Trodelvy + Pembrolizumab to chemotherapy + Pembrolizumab (#LBA22) on October 20.
- - EDGE-Gastric findings related to advanced gastric or esophageal adenocarcinoma (#2112MO) on October 18.
As Gilead and Kite continue their efforts within oncology, the introduction of innovative therapies such as Trodelvy, Domvanalimab, and Zimberelimab underscore the companies’ commitment to addressing treatment gaps for diverse cancer types. Gilead has been at the forefront of biopharmaceutical innovation for over 30 years, aiming to create a healthier world through medical advancements against life-threatening diseases.
Topics Health）
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