Illuminating Findings from Kelun-Biotech's TROP2 ADC at the 2025 ASCO GU Symposium

Exploring Kelun-Biotech's Innovative ADC at ASCO GU 2025

At the upcoming American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium 2025, which is set to take place in San Francisco, USA, from February 13 to 15, 2025, key findings will be unveiled regarding the efficacy and safety of sacituzumab tirumotecan (sac-TMT), an exciting new anti-TROP2 antibody-drug conjugate (ADC) developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. This pivotal research targets patients suffering from unresectable locally advanced or metastatic urothelial carcinoma (UC) who have already undergone previous treatments.

The Phase 1/2 KL264-01/MK-2870-001 study's promising results will be highlighted in a poster session on February 14, 2025 (Abstract #796). The study enrolled participants with confirmed locally advanced or metastatic UC, who had experienced disease progression after at least one line of platinum-based chemotherapy and prior anti-PD-(L)1 therapy.

Study Insights

As of June 30, 2024, a total of 49 patients were treated with sac-TMT, which was administered at a dosage of 5 mg/kg every two weeks until progression of the disease was observed, unacceptable toxicity occurred, or consent was withdrawn. Preliminary data indicates that patients had a median age of 62 years, with the majority being of Asian descent.

The clinical outcomes were promising, with the overall objective response rate (ORR) reaching 31%. For those receiving sac-TMT as a second-line treatment (2L), the confirmed ORR stood at 45%, while for patients in subsequent lines of therapy (3L+), the ORR was 26%. Notably, one patient experienced a complete response (CR) within the 2L category, while others showed varying degrees of disease stability and response according to the study’s parameters.

Safety Profile

From a safety perspective, the results were consistent with expectations based on previous clinical experiences with ADCs. Grade 3 treatment-related adverse events (TRAEs) were observed in 59% of the participants, with anemia being the most commonly reported issue (39%). Other notable adverse events included decreased neutrophil and white blood cell counts. Importantly, no grade 5 TRAEs occurred, underscoring a relatively manageable safety profile for this treatment.

About Sacituzumab Tirumotecan

Sacituzumab tirumotecan represents a significant advancement in the ADC therapeutic landscape. It is designed to specifically target TROP2, a protein overexpressed in many cancers, including UC. The innovative payload, a belotecan-derivative topoisomerase I inhibitor, is conjugated to an anti-TROP2 antibody, facilitating targeted delivery of the cytotoxic agent directly to tumor cells. This mechanism of action promotes a bystander effect, potentially eliminating adjacent tumor cells and enhancing therapeutic efficacy.

Having already received marketing authorization for use in China for treating advanced triple-negative breast cancer, sac-TMT is gaining traction as a versatile therapeutic candidate across multiple cancer types. The successful collaborations with international partners, including Merck & Co., underscore its potential for global impact.

Conclusion

The findings from the ASCO GU 2025 symposium will undoubtedly provide critical insights into the evolving landscape of cancer treatments, particularly in urothelial carcinoma. As Kelun-Biotech continues to innovate in the development of targeted therapies, the medical community eagerly anticipates the implications of these results for improving outcomes for patients suffering from advanced malignancies.

For more information about Kelun-Biotech and its groundbreaking research, please visit Kelun-Biotech.