Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp & Dohme, and the studies indicate promising efficacy and safety profiles for the treatment of non-small cell lung cancer (NSCLC) and gastric cancer/gastroesophageal junction carcinoma (GC/GEJC).
Phase II NSCLC Study Results:
The study enrolled 43 NSCLC patients with a median follow-up time of 17.2 months. Notably, 21 wild-type EGFR patients had previously received a median of 3-line treatments including anti-PD-1/L1 inhibitors. The overall response rate (ORR) was 43.6%, with a median duration of response (mDoR) of 9.3 months. The median progression-free survival (mPFS) was 7.2 months, and the median overall survival (mOS) reached 22.6 months, demonstrating a strong survival benefit. The 12 and 18-month OS rates were 69.0% and 56.5%, respectively. The safety profile was manageable, with the most common treatment-related adverse events (TRAE) being decreased neutrophil count, anemia, and decreased white blood cell count.
Phase II GC/GEJC Study Results:
In the gastric cancer study, 48 patients were enrolled with at least 9 weeks of follow-up. Half of the patients had received first-line treatment, and the other half had received second-line or later treatment. The ORR among the 41 evaluable patients was 22.0%, the disease control rate (DCR) was 80.5%, and the duration of response (DoR) was 7.5 months. The safety profile was similarly manageable, with anemia and decreased neutrophil count being the most common TRAE of grade 3 or above.
These results position sac-TMT as a potential new treatment option for patients with TROP2-expressing cancers, offering a new therapeutic approach in the fight against NSCLC and GC/GEJC.- Flcube.com
