Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), is poised to present updated results from a Phase II study expansion cohort for its antibody-drug conjugate, SKB264, targeting previously treated metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio Breast Cancer Symposium (SABCS) 2023.
As of the data cut-off on May 5, 2023, a total of 59 mTNBC patients were enrolled in the study, with 88% having undergone three or more prior treatments for metastatic disease. The median follow-up duration was 22.8 months, revealing an objective response rate (ORR) of 42.4% and a disease control rate (DCR) of 76.3%. The median duration of relief (mDoR) was recorded at 11.5 months, while median progression-free survival (mPFS) was 5.7 months. The median overall survival (mOS) reached 16.8 months, with overall survival rates of 65.0% and 39.5% at 12 and 24 months, respectively. Notably, among patients with high TROP2 expression (H-score ≥ 200, n=32), the ORR improved to 53.1%, with an mDoR of 11.1 months and an mPFS of 5.8 months; the mOS has yet to be achieved, with 12- and 24-month OS rates of 65.3% and 57.3%, respectively.
The most frequently reported level 3 treatment-related adverse events (TRAE) included decreased neutrophil count, decreased white blood cell count, anemia, and decreased platelet count. Importantly, no cases of interstitial lung disease (ILD), neurotoxicity, or grade 3 diarrhea were reported, and no TRAE-related fatalities occurred.
SKB264 is currently under development for treating TNBC, non-small cell lung cancer (NSCLC), and HR+/HER2- breast cancer, among other malignancies. The drug received breakthrough therapy designation (BTD) in China for TNBC in July 2022 and was included in a licensing agreement with Merck, Sharp & Dohme (MSD) for territories outside Greater China in May 2022. A Phase III study for SKB264 in TNBC successfully reached its primary endpoints in August this year.- Flcube.com
