Kelun Pharmaceutical Subsidiary's Novel TROP2-ADC SKB264 (MK-2870) Phase II Expansion Data in NSCLC Published at 2023 ASCO Annual Meeting

Intelligent Finance APP News, Kelun (002422.SZ) announced that it has recently learned that SKB264 (MK-2870), the innovative TROP2-ADC jointly developed by its holding subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., LTD ("Kelun-Biotech") and Merck & Co., Inc. (Rahway, NJ, USA), will disclose the Phase II expansion study results of non-small cell lung cancer (NSCLC) patients (poster presentation) at the 2023 American Society of Clinical Oncology Annual Meeting (2023 ASCO Annual Meeting). The abstract was released at 5:00 p.m. Eastern Time on May 25, 2023.

This study is a multicenter, dose-escalation and dose-expansion phase 1/2 clinical trial for patients with recurrent or refractory locally advanced or metastatic non-small cell lung cancer and other solid tumors. As of the data cutoff date of February 9, 2023, the median follow-up time was 11.5 months.

Among the 39 evaluable patients (who received SKB264 5 mg/kg, Q2W), the objective response rate (ORR) was 44%, 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 had previously failed EGFR-TKI treatment, with 50% also having received at least one chemotherapy regimen. The ORR was 60%, the disease control rate (DCR) was 100%, the median progression-free survival (PFS) was 11.1 months, and the 9-month PFS rate was 66.7%. In the EGFR wild-type subgroup, all patients had previously failed PD-1/L1 antibody treatment (median number of prior treatments was 2). The ORR was 26%, the DCR was 89%, the median PFS was 5.3 months, and the 9-month overall survival (OS) rate was 80.4%.

The most common ≥3 grade treatment-related adverse events (≥5%) were decreased neutrophil count, anemia, decreased white blood cell count, oral mucositis, rash, and decreased lymphocyte count. Most hematologic adverse events occurred within the first two months after initiating SKB264 treatment and were recoverable after treatment with granulocyte colony-stimulating factor or erythropoietin. No neurotoxicity, drug-related interstitial lung disease (ILD), or non-infectious pneumonia was observed. There were no discontinuations or deaths due to treatment-related adverse events.