Breakthrough Results for Kelun-Biotech's Sacituzumab Tirumotecan in Top Medical Journal

Kelun-Biotech's Groundbreaking Publication

In a significant advancement in the field of oncology, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that the results from their Phase 3 registrational clinical study on the innovative TROP2 antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), were published in the prestigious journal, Nature Medicine. This publication spotlights the transformative potential of sac-TMT in treating advanced-stage breast and lung cancers, specifically targeting triple-negative breast cancer (TNBC) and advanced non-small-cell lung cancer (NSCLC).

Clinical Trial Insights

The Phase 3 randomized clinical trial, known as the OptiTROP-Breast01 study (NCT05347134), primarily focused on patients suffering from locally advanced, recurrent, or metastatic TNBC. The findings demonstrated substantial effectiveness of sac-TMT compared to investigator's choice chemotherapy. Notably, patients treated with sac-TMT experienced significant enhancements in both progression-free survival (PFS) and overall survival (OS).

As a result of this pivotal study, sac-TMT received marketing approval for patients with unresectable locally advanced or metastatic TNBC who had already undergone at least two systemic therapies. These landmark results were also featured prominently during an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

In addition to the TNBC findings, the publication discussed early Phase I/II trials for sac-TMT in previously treated advanced NSCLC cases. The studies indicated effective outcomes regardless of the presence of epidermal growth factor receptor (EGFR) mutations. The research further delved into the cellular mechanisms, suggesting that these mutations might enhance the uptake and anti-cancer activity of TROP2 ADCs.

Leadership Commentary

Dr. Michael Ge, the CEO of Kelun-Biotech, expressed pride in the recognition garnered through this publication, emphasizing that it reflects the clinical efficacy and potential of sac-TMT within the international medical community. He stated, "These successful publications in Nature Medicine mark the international academic community's recognition of the clinical efficacy and application value of sac-TMT in the treatment of advanced TNBC and NSCLC."

Underlining their commitment to innovate, Kelun-Biotech has already secured marketing rights in China for sac-TMT and is actively pursuing further studies to explore its applications in various cancer types beyond breast and lung cancer.

Product Profile: Sacituzumab Tirumotecan (sac-TMT)

Sac-TMT, Kelun-Biotech’s flagship product, is designed to target advanced solid tumors, including those in lung and breast cancers. The compound operates through a novel mechanism involving a humanized anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor, belotecan. This linkage allows sac-TMT to selectively destroy tumor cells—by first binding to TROP2 on the surface and then inducing damage to their DNA, leading to cancer cell death.

With its formulation capable of a bystander effect, sac-TMT promises broader therapeutic potential by also affecting neighboring tumor cells within its microenvironment. As the first domestic ADC to receive global intellectual property rights, sac-TMT stands at the forefront of cancer therapeutics.

Global Impact and Future Directions

The company has licensed the rights to MSD (Merck & Co., Inc.) to facilitate the development and commercialization of sac-TMT outside Greater China. The drug has already been approved in China for specific oncology indications, highlighting its significance in addressing unmet medical needs.

Kelun-Biotech is driving forward, with multiple clinical studies underway, underscoring their ambition to introduce sac-TMT to a wider global market while improving treatment landscapes for patients struggling with cancer.

As the journey of sac-TMT continues, its innovative approach to cancer therapy signals hope for patients and reinforces the importance of ongoing research and collaboration in the fight against cancer.