#China #Chengdu #Kelun-Biotech #Sacituzumab #TROP2 ADC

Kelun-Biotech Announces Key Study Results in Gynecologic Oncology

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has gained notable attention in the medical community following its presentation of pivotal results at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting held in San Juan, Puerto Rico. The study focused on sacituzumab tirumotecan (often referred to as sac-TMT), specifically its applications in treating ovarian and cervical cancers, in conjunction with MSD's pembrolizumab (brand name: KEYTRUDA®).

Significant Findings from Ovarian Cancer Cohort

In a Phase II study titled SKB264-II-06/MK-2870-002, Kelun-Biotech outlined compelling evidence of sac-TMT's effectiveness as maintenance therapy for patients with second-line platinum-sensitive recurrent ovarian cancer. This was particularly groundbreaking as it appeared to improve patient outcomes, particularly amongst those who had previously undergone bevacizumab therapy. Of the 40 participants, a clear distinction emerged based on treatment dosage: 27 patients received sac-TMT combined with pembrolizumab at a dose of 4 mg/kg every two weeks, while 13 patients were treated with a higher dosage of 5 mg/kg.

The results indicated a median progression-free survival (PFS) of 20.9 months and a remarkable overall survival (OS) rate of 92% at the 12-month mark. It's noteworthy that the adverse events associated with sac-TMT were generally manageable, reducing concerns related to treatment safety. Common side effects such as anemia and stomatitis were documented, but importantly, no treatment-related deaths occurred.

Insights from the Cervical Cancer Cohort

Alongside the ovarian cancer findings, the cervical cancer portion of the study enrolled 68 patients who had previously undergone two or more lines of therapy for recurrent or metastatic cervical cancer. Participants were administered sac-TMT at varying dosages (ranging from 3 mg/kg to 5 mg/kg) in combination with pembrolizumab. The study revealed a notable objective response rate (ORR) of 51%, with slightly higher rates observed among those pretreated with immunotherapy.

Median PFS in this group was recorded at 7.3 months, while median OS reached 18.9 months. Similar to the ovarian cancer cohort, the safety profile for cervical cancer patients remained manageable, underscoring the potential of sac-TMT as a valuable therapeutic approach for managing cervical cancer.

Overview of Sam-TMT

Sac-TMT represents a significant advancement in the treatment of multiple advanced solid tumors, leveraging a novel delivery approach that emphasizes tumor specificity. Developed with a proprietary dual-function linker, the drug is designed to enhance the efficacy and accuracy of chemotherapy delivery to malignant cells. Preliminary findings suggest that sac-TMT could herald a new era in targeted cancer treatments, offering a fresh lifeline to patients battling advanced gynecological cancers.

Future Prospects

the results coming out of these studies are expected to play a crucial role in further clinical studies and eventual commercialization. Kelun-Biotech has expressed commitment to broaden its clinical exploration of sac-TMT in a variety of tumor types, aiming to establish this promising therapy firmly as a frontline treatment option.

As of 2026, the use of sac-TMT in oncology is quickly gaining traction, and the company is poised to make significant contributions to addressing the unmet needs of cancer patients worldwide. With multiple ongoing studies underpinned by the robust data from the SGO presentation, Kelun-Biotech appears well-positioned to shape the future landscape of gynecologic oncology.