Kelun Pharmaceutical's TROP2 ADC was approved for Phase III clinical trials for triple-negative breast cancer

On April 7, Kelun Pharmaceuticals announced that the TROP2 antibody conjugated drug SKB264 (TROP2-ADC) has been approved for clinical treatment of patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy

SKB264 is a TROP2 antibody-drug conjugate (TROP2-ADC) with independent intellectual property rights of Colombotech.

SKB264 domestic research and development process

From: Insight database project progress module (http://db.

At the 2021 ESMO and CSCO meetings, Kelun announced the preliminary clinical data of SKB264

From: CSCO, Kelun Pharmaceutical Official Weibo

The enrolled patients were patients with locally advanced or metastatic solid tumors who had failed multiple lines of therapy

A total of 17 patients underwent at least one efficacy evaluation, with an overall response rate (ORR) of 41.

From: CSCO, Kelun Pharmaceutical Official Weibo

In terms of safety, adverse events (AEs) were reported in all 18 patients, and they all recovered after symptomatic treatment

Early clinical study results of SKB264 showed good tolerability, safety, and encouraging antitumor activity in patients with metastatic solid tumors, with particularly impressive efficacy data in TNBC and ovarian cancer, gastric adenocarcinoma, pancreatic Longer duration of sustained remission or stable disease has also been observed in cancer and deserves further exploration

At present, SKB264 is continuing to explore a series of indications in the phase II expansion study, among which the phase II expansion enrollment for TNBC has been completed and phased clinical data have been obtained

Breast cancer is the number one malignant tumor that seriously threatens women's health in the world.