Korean J Urol Oncol.  2021 Nov;19(4):252-260. 10.22465/kjuo.2021.19.4.252.

Subcutaneous Interleukin-2 Monotherapy for Metastatic Renal Cell Carcinoma in Korean Patients

• Kim JH
• Lee KS
• Kim CS
• Choi YD
• Kim TH

• KMID: 2522846
• DOI: http://doi.org/10.22465/kjuo.2021.19.4.252

Abstract

Purpose
This study was a prospective single-arm clinical trial aimed at assessing the efficacy and toxicity of subcutaneous interleukin (IL)-2 monotherapy in patients with metastatic renal cell carcinoma (RCC).
Materials and Methods
We enrolled 26 patients with metastatic RCC in this multicenter controlled trial. The patients received subcutaneous injections of recombinant IL-2 (BMI-rh-IL2, an aldesleukin biosimilar, BMIKOREA Co., Ltd.) in 5-week cycles. In the first week, the patients received a subcutaneous IL-2 loading dose of 18×10⁶ IU once on treatment days 1–5, followed by 2 days of rest. In the following 3 weeks, they received a dose of 18×10⁶ IU via subcutaneous injection once on treatment days 1 and 2. Then, the patients received a dose of 9×10⁶ IU via subcutaneous injection once on treatment days 3, 4, and 5, followed by 2 days of rest. The primary end point was the objective response rate; the secondary end points were progressionfree survival (PFS) and safety.
Results
Overall, 22 patients were included in the final per-protocol analysis. The objective response and the disease control rates were 13.64% (3 of 22), and 90.9% (20 of 22), respectively. The mean PFS was 5.55 months (95% confidence interval, 2.71–8.4). The proportion of patients who experienced a treatment-related grade 3 or 4 adverse event was 3.85% (1 of 26). There were no treatment-related deaths.
Conclusions
In this study, the subcutaneous IL-2 monotherapy regimen demonstrated efficacy and safety comparable to those reported in previous studies of subcutaneous IL-2 monotherapy and was effective in Korean patients with metastatic RCC.

Keyword

Renal cell carcinoma, Interleukin-2, Clinical trial, Metastasis, Subcutaneous injections