Multiple Study Results of Kelun-Biotech's TROP2-ADC SKB264 (sac-TMT) at 2024 CSCO Congress

Core Insights - The Phase III OptiTROPBreast01 study demonstrated that sacituzumab tirumotecan (sac-TMT) significantly improves progression-free survival (PFS) and overall survival (OS) in patients with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) compared to chemotherapy [2][3] - The study results indicate that sac-TMT could become a new standard of second-line treatment for advanced TNBC, addressing the high unmet medical need in this patient population [3] - The emergence of antibody-drug conjugates (ADCs) like sac-TMT is seen as a transformative development in cancer treatment, with potential applications across various cancer types, including non-small-cell lung cancer (NSCLC), cervical cancer, endometrial cancer, and ovarian cancer [6][11] Group 1: Triple-Negative Breast Cancer (TNBC) - The median PFS for sac-TMT was 6.7 months, compared to 2.5 months for chemotherapy, representing a 68% reduction in the risk of disease progression or death [2] - In patients with TROP2 H-score > 200, the median PFS was 8.3 months with sac-TMT versus 2.3 months with chemotherapy [2] - The median OS was not reached for sac-TMT, while it was 9.4 months for chemotherapy, indicating a 47% reduction in the risk of death with sac-TMT [2] Group 2: Non-Small-Cell Lung Cancer (NSCLC) - The Phase II OptiTROP-Lung01 study showed an overall response rate (ORR) of 48.6% for cohort 1A and 77.6% for cohort 1B, with median PFS of 15.4 months for cohort 1A [5][6] - The combination of sac-TMT with KL-A167, an anti-PDL1 monoclonal antibody, is leading a new direction in first-line treatment for advanced NSCLC [6] Group 3: Cervical Cancer - In a study involving recurrent or metastatic cervical cancer, the ORR was 57.9% with a median follow-up of 6.2 months, indicating promising efficacy [7][8] - High TROP2 expression in cervical cancer patients suggests that sac-TMT could be an effective treatment option [8] Group 4: Endometrial and Ovarian Cancer - In the endometrial cancer cohort, the ORR was 34.1% with a median PFS of 5.7 months, while in the ovarian cancer cohort, the ORR was 40% with a median PFS of 6.0 months [9][10] - The results indicate that sac-TMT has the potential to overcome platinum resistance in advanced endometrial and ovarian cancers, providing new therapeutic strategies [11] Group 5: Company Commitment - Kelun-Biotech is focused on addressing unmet clinical needs through the development of novel ADC drugs, aiming to enhance patient outcomes and contribute to the realization of Healthy China 2030 [11]