Kelun-Biotech to present recent clinical data for SKB264 (TROP2 ADC) at ASCO 2023

2023 ASCO | Kelun Biotech SKB264 (TROP2-ADC) releases research data of non-small cell lung cancer for the first time

On May 25, US Eastern Time, the official website of the 2023 ASCO Annual Meeting published abstracts of some of the selected studies for the meeting. The innovative TROP2-ADC (SKB264, MK-2870) jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc Rahway NJ USA), with the Phase 2 expansion study data for previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), has been published on the official website of ASCO.

The data cut-off is February 9, 2023, and the median follow-up time is 11.5 months.

Efficacy: 39 NSCLC patients were evaluable for efficacy (who had received SKB264 at 5 mg/kg, Q2W): the objective response rate (ORR) was 44% (17/39), the disease control rate (DCR) was 95% (37/39), the median duration of response (DoR) was 9.3 months, and the 6-month DoR rate was 77%.

In the EGFR mutant subgroup, all patients were EGFR-TKI resistant, and 50% of the patients had received at least one chemotherapy regimen. Subgroup analysis showed that the ORR was 60% (12/20), the disease control rate (DCR) was 100% (20/20), and the median progression-free survival (PFS) was 11.1 months, with 9-month PFS rate of 66.7%.

In the EGFR wild-type subgroup, all patients had previously failed anti-PD-1/L1 therapy and the median prior lines of therapy was 2. Among this subgroup, the ORR was 26% (5/19), the DCR was 89% (17/19), the median PFS was 5.3 months, and the 9-month overall survival (OS) rate was 80.4%.

Safety: Grade ≥3 treatment-related adverse events (TRAEs) were reported in 67.4% (29/43) of patients. The most common Grade ≥3 TRAEs (≥ 5%) were decreased neutrophil count, anemia, decreased white blood cell count, oral mucositis, rash, and decreased lymphocyte count. Most blood-related adverse events occurred within two months of starting SKB264 treatment and recovered after treatment with granulocyte colony-stimulating factor and erythropoietin. TRAEs led to a dose reduction rate of 23.3%, and no discontinuation or death due to TRAEs occurred. No neurotoxicity or drug-related interstitial lung disease (ILD)/pneumonitis was observed.

In previously treated patients with locally advanced or metastatic NSCLC, SKB264 demonstrated encouraging antitumor activity and a manageable safety profile. A Phase 3 registrational study of SKB264 for the treatment of locally advanced or metastatic NSCLC is in progress.

About SKB264 (TROP2-ADC)
SKB264 is a new generation of antibody-drug conjugates (ADC) composed of a humanized
monoclonal antibody targeting TROP2, an enzymatically cleavable linker and a novel topoisomerase I inhibitor for which Kelun-Biotech has independent intellectual property rights. SKB264 combines the specificity of monoclonal antibodies to target antigens on the surface of tumor cells and the high cell-killing efficiency of cytotoxic drugs. SKB264 has been granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer and locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Based on preliminary clinical data, SKB264 is currently conducting Phase 2 and Phase 3 clinical trials involving monotherapy and combination therapy for multiple tumor types. In China, the Phase 3 registrational clinical study of SKB264 monotherapy for advanced or metastatic TNBC patients who have failed at least second-line treatment is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for marketing. Phase 3 clinical research of SKB264 monotherapy for TKI-resistant EGFR-mutated non-small cell lung cancer patients is also rapidly advancing. Several Phase 2 clinical studies of SKB264 combined with pembrolizumab (KEYTRUDA®, MSD’s anti-PD-1 therapy) or KL-A167 (anti-PD-L1 monoclonal antibody) are under development. In addition, Kelun-Biotech has granted an exclusive license to MSD to manufacture, develop, and commercialize SKB264 (also known as MK-2870) outside of Greater China territories (Greater China includes Mainland China, Hong Kong, Macau and Taiwan). Global clinical research in several major countries, including United States, Canada, Australia, France, Spain, Belgium and Poland, are currently ongoing while additional multi-center clinical studies are also under preparation.

About Kelun-Biotech
Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, focusing on the R&D, production, commercialization and international cooperation of innovative biologics and small molecule drugs. Focusing on the unmet clinical needs in China and the rest of world, the company aims to treat major diseases, including solid tumors, autoimmune, inflammatory and metabolic diseases. By building an international drug R&D and industrialization platform, the company strives to become an international leading enterprise in the field of innovation. Significant progress has been made in the field of biologic drugs, including ADC, monoclonal antibody, bispecific antibody, as well as novel targets for innovative small molecule drug discovery, etc. The world-renowned ADC R&D platform, OptiDC, has been successfully established, from which 4 ADCs are in the clinical research stage, and several are in the preclinical research stage. The company currently has 33 innovative projects for the treatment of major diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, including 14 projects advancing in clinical research, of which 3 are being carried out concurrently in China and the United States.