Kelun-Biotech's Sacituzumab Tirumotecan: A Breakthrough in Advanced Breast Cancer Treatment

Promising Advances in Breast Cancer Treatment

The recent presentation at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin highlighted groundbreaking results from Kelun-Biotech’s Phase 3 clinical trial, known as OptiTROP-Breast02. This study focused on sacituzumab tirumotecan (brand name: 佳泰莱®), a targeted therapy option for patients suffering from advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Conducted by Professor Man Li of the Second Affiliated Hospital of Dalian Medical University, the findings demonstrated that sacituzumab tirumotecan significantly improves progression-free survival (PFS) compared to traditional chemotherapy options.

Study Insights and Findings

In this extensive clinical trial, 399 patients with HR+/HER2- breast cancer, who had shown progression on CDK4/6 inhibitors and received at least one previous chemotherapy regimen, were enrolled. They were randomized to receive either sacituzumab tirumotecan or an investigator's choice of chemotherapy. The results as of January 22, 2025, showed that patients receiving sac-TMT had a median PFS of 8.3 months, compared to just 4.1 months for those receiving standard chemotherapy. This robust advantage was statistically significant, with a hazard ratio (HR) of 0.35, indicating a 65% reduction in the risk of disease progression in the sac-TMT group.

Furthermore, the trial revealed that this clinical benefit associated with sac-TMT was independent of HER2 expression status, underscoring its effectiveness across various patient profiles. Notably, the trial also indicated improved overall response rates (ORR) and duration of response (DoR) with sac-TMT compared to chemotherapy, along with a trend suggesting a beneficial impact on overall survival (OS), though additional data would be necessary to confirm these results.

Safety Profile and Future Directions

The safety profile of sac-TMT appeared favorable, with grade ≥3 treatment-related adverse events (TRAEs) occurring in 62.0% of patients receiving sac-TMT versus 64.8% in the chemotherapy group. Importantly, the rates of severe events leading to discontinuation were negligible, demonstrating that sac-TMT can be a well-tolerated option for patients. Notably, instances of pneumonitis were low and classified as mainly grade 1-2 in severity.

Looking forward, Kelun-Biotech is currently pursuing additional studies, including a Phase 3 trial exploring sacituzumab tirumotecan both as monotherapy and in combination with pembrolizumab for chemotherapy-naïve HR+/HER2- breast cancer patients. This study aims to enroll 1,200 participants globally, while another study continues in China with a focus on the same patient population.

A Landmark in Breast Cancer Research

Professor Man Li remarked on the significance of the OptiTROP-Breast02 study, noting that it represents the first Phase 3 clinical trial targeting an exclusively Chinese population with HR+/HER2- breast cancer. He emphasized that these findings not only provide critical evidence-based support for treating this patient demographic but also signify a step forward in creating safe and effective treatment options.

About Sacituzumab Tirumotecan

Sacituzumab tirumotecan is a first-in-class antibody-drug conjugate designed to target TROP2, a protein commonly overexpressed in various solid tumors, including breast cancer. It employs a unique mechanism to deliver the cytotoxic drug directly to cancer cells, enhancing the treatment's efficacy while aiming to reduce systemic toxicity. Authorized in several indications in China, sac-TMT has proven to be effective against advanced solid tumors and is solidifying its role in the contemporary oncology landscape.

Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, remains committed to advancing innovative drug development and meeting unmet medical needs, particularly in the realm of oncology. With over 30 ongoing innovative projects, including multiple registrational studies, the company aspires to introduce more transformative therapeutic options into clinical practice worldwide. For more details about their ongoing research and product portfolio, visit Kelun-Biotech's website.