#China #Chengdu #Kelun-Biotech #KEYTRUDA #Sac-TMT

Kelun-Biotech Achieves Phase III Trial Success

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. recently announced that their Phase III clinical trial, named OptiTROP-Lung05, has reached its primary endpoint, demonstrating a significant advancement in treating PD-L1-positive advanced non-small cell lung cancer (NSCLC) using their drug, sacituzumab tirumotecan (sac-TMT), in combination with Merck's KEYTRUDA® (pembrolizumab). This pivotal success marks the first time a trop2 antibody-drug conjugate (ADC) has met its primary endpoint in a Phase III trial as a first-line treatment for NSCLC, signifying substantial hope for cancer patients.

Trial Details and Findings

The OptiTROP-Lung05 trial was a randomized, open-label study assessing the effectiveness and safety of sac-TMT alongside pembrolizumab in comparison to pembrolizumab used alone for patients diagnosed with locally advanced or metastatic NSCLC. The trial focused on patients with a PD-L1 tumor proportion score (TPS) of 1% or greater. The Independent Data Monitoring Committee (IDMC) reported a statistically significant improvement in progression-free survival (PFS), the primary endpoint of the study, indicating a promising trend for overall survival (OS) as well.

Based on the positive interim analysis results, Kelun-Biotech plans to engage with the National Medical Products Administration (NMPA) in China to discuss filing a supplemental new drug application (sNDA) for sac-TMT. The FDA has already approved sac-TMT in China for treating EGFR-mutant NSCLC in later stages, adding to its significance and credibility within the pharmaceutical landscape.

Unique Mechanism and Potential

Sac-TMT is a novel ADC that links a topoisomerase I inhibitor to an anti-TROP2 monoclonal antibody, targeting specific cancers including NSCLC, breast cancer, and gastric cancers, among others. This drug works by selectively recognizing TROP2 present on tumor cells, allowing the ADC to be absorbed and release its cytotoxic payload directly inside the tumor, effectively damaging DNA and causing tumor cell death.

The anticipation culminates from multiple studies showcasing sac-TMT's approval for various indications in China. It has exhibited impressive results for patients suffering from advanced conditions, paving a path toward its eventual global deployment under the collaboration with Merck. Currently, Kelun-Biotech has registered ten studies for sac-TMT in lung cancer, with several ongoing Phase III clinical trials being managed by MSD, broadening its reach and enhancing collaborative efforts for diverse cancer therapies.

The Future of Kelun-Biotech and Overarching Goals

Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, is positioning itself to become a global player in innovative drug development, prioritizing drug formulation for malignant diseases, as well as autoimmune and inflammatory disorders. With over 30 innovative drug projects in progress, the company aims to address significant unmet medical needs both in China and internationally. The swift advancement from clinical trials to market readiness speaks volumes about their commitment to tackling critical health issues effectively.

Achieving this milestone in the OptiTROP-Lung05 trial signifies not only a leap forward for the company but also instills hope for patients confronting one of the most challenging types of cancer, promising better outcomes and potentially life-saving treatment options.

As Kelun-Biotech continues its exploration and advancements, the expectations around sac-TMT and its collaborative efforts with Merck will undoubtedly ripple through the healthcare and pharmaceutical sectors, carrying forward a commitment to enhancing patient care and treatment efficacy worldwide.