Breakthrough in Breast Cancer Treatment: Kelun Biotech's Sacituzumab Tirumotecan Shines at ESMO 2025

CANCER BREAKTHROUGH: Kelun Biotech has unveiled pivotal Phase 3 clinical trial results for its innovative antibody-drug conjugate (ADC), Sacituzumab Tirumotecan (SKB264), offering a beacon of hope for patients battling advanced hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer. Presented at the prestigious 2025 European Society for Medical Oncology (ESMO) Congress, the OPTITROP-Breast02 study demonstrated statistically significant and clinically meaningful improvements, marking a potential paradigm shift in treating this challenging disease.

HR+/HER2- breast cancer represents the most prevalent subtype globally, and while initial treatments often include endocrine therapy, patients frequently face progression, necessitating further therapeutic options.

For those who have failed multiple lines of treatment, including endocrine therapy and prior chemotherapy, effective new solutions are desperately needed. SKB264 emerges as a promising candidate in this critical unmet need.

The OPTITROP-Breast02 study rigorously evaluated the efficacy and safety of Sacituzumab Tirumotecan in patients with advanced HR+/HER2- breast cancer who had previously undergone at least two lines of systemic therapy.

The trial successfully met its primary endpoint, showcasing a superior progression-free survival (PFS) compared to the control group receiving standard chemotherapy. This significant finding underscores SKB264's potential to extend the time patients live without their disease progressing, a crucial outcome for those living with advanced cancer.

Sacituzumab Tirumotecan is an advanced TROP2-directed antibody-drug conjugate.

TROP2 (trophoblast cell-surface antigen 2) is a protein highly expressed in various solid tumors, including breast cancer, making it an excellent target for precision therapies. ADCs are revolutionary cancer treatments that combine the specificity of monoclonal antibodies to target cancer cells with the potent cell-killing ability of cytotoxic drugs, minimizing damage to healthy tissues.

SKB264 is designed to deliver a chemotherapy payload directly to TROP2-expressing cancer cells, leading to more effective and targeted cell death.

The positive results from OPTITROP-Breast02 are a testament to Kelun Biotech's commitment to developing innovative oncology solutions. The data suggests that SKB264 could provide a much-needed new treatment avenue for patients whose disease has progressed despite current therapeutic options.

The safety profile observed in the trial was consistent with previous studies, reinforcing its potential for clinical application.

Experts anticipate that these findings will pave the way for regulatory submissions, bringing Sacituzumab Tirumotecan closer to patients worldwide. The oncology community eagerly awaits further detailed analysis and the full impact this new treatment could have on improving patient outcomes and quality of life in advanced HR+/HER2- breast cancer.

This development represents a significant stride in the ongoing fight against cancer, offering renewed hope and a powerful new weapon in the therapeutic arsenal.