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On September 17, Kelun Pharmaceutical issued an announcement stating that the TROP2 antibody-drug conjugate SKB264 developed by the company will be announced in 2021 by the European Society of Medical Oncology ([2021 ESMO Annual Meeting])
.
Professor Jordi Rodon Ahnert of MD Anderson and Professor Li Jin of the Oriental Hospital Affiliated to Tongji University are the co-lead investigators of the global multi-center clinical study of SKB264.
The results of the interim clinical study of the SKB264 project phase I have been reported orally in the developmental therapeutics special session at 14:20-14:30, September 17th, Central European Daylight Time (20:20-20:30, September 17th, Beijing time) ( Proffered Paper).
This is the first time that SKB264 has displayed research data.
The summary of the content is as follows:
An open-label, global, first-in-human study of SKB264 in patients with locally advanced or metastatic solid tumors (An open-label, global, first-in-human study of SKB264 in patients with locally advanced or metastatic solid tumors)
SKB264 is an innovative TROP2-ADC drug independently developed by Kelun Botai, which uses linkers and toxin molecules with independent intellectual property rights
.
In animal models of lung cancer and breast cancer, SKB264 showed good anti-tumor activity, and the anti-tumor activity also showed a significant dose correlation
The enrolled population of the Phase I study is patients with advanced/metastatic solid tumors, and the main purpose is to determine the maximum tolerated dose (MTD) and/or recommended extended doses (RDEs)
.
As of March 15, 2021, there are a total of 18 patients in China and the United States (median age is 57 years), including 4 patients in the 2 mg/kg dose group, 7 patients in the 4 mg/kg dose group, and 7 patients in the 6 mg/kg dose group, 55.
6% Of patients have received ≥4 treatment options in the past
.
Among them, 6 were TNBC patients (33.
In terms of clinical safety, 18 patients all reported adverse events (AEs), of which 8 patients reported ≥ Grade 3 AEs, and> 2 patients with Grade 3 AEs had decreased neutrophil count (5/18) and white blood cell count Decrease (4/18) and anemia (3/18)
.
There were no AEs leading to permanent discontinuation of the study, and no AEs leading to death
In terms of clinical effectiveness, a total of 17 patients received at least one efficacy evaluation, and the enrolled population were all patients with advanced or metastatic solid tumors who had failed multi-line treatment
.
The overall response rate (ORR) was 35.
