์•Œ๋ฆผ
๋’ค๋กœ
mobile background
Korean Cancer Study Group 
Webzine Vol.36  JUNE 2025 
mobile background
KCSG ์—ฐ๊ตฌ ๋…ผ๋ฌธ ์†Œ๊ฐœ
โ–ถ KCSG HN18-17 
A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12) 

์ €๋„: Oncoimmunology. 2024 Jun 24;13(1):2371563.

 

์ œ1์ €์ž ์ด๋™๊ธฐ (์„ธ๋ธŒ๋ž€์Šค๋ณ‘์›) 

 

Q. ์—ฐ๊ตฌ์˜ ๋ฐฐ๊ฒฝ์€?

์‹๋„ ํŽธํ‰์ƒํ”ผ์„ธํฌ์•”์˜ 1์ฐจ ์น˜๋ฃŒ๋Š” platinum-based chemotherapy๋กœ, ์ด์— ๋Œ€ํ•œ ๋‚ด์„ฑ์ด ๋ฐœ์ƒํ•œ ํ›„ ํšจ๊ณผ์ ์ธ 2์ฐจ ์น˜๋ฃŒ์˜ ์„ ํƒ์ง€๊ฐ€ ์ œํ•œ์ ์ž…๋‹ˆ๋‹ค. Spartalizumab (PDR001)์€ ์ตœ๊ทผ ์—ฌ๋Ÿฌ ์•”์—์„œ ์œ ๋งํ•œ ์น˜๋ฃŒ ์˜ต์…˜์œผ๋กœ ๋ถ€๊ฐ๋œ PD-1 ์–ต์ œ์ œ๋กœ, ๋ณธ ์—ฐ๊ตฌ๋Š” spartalizumab์˜ ํšจ๊ณผ์™€ ์•ˆ์ „์„ฑ์„ ํ‰๊ฐ€ํ•˜๊ธฐ ์œ„ํ•ด ์„ค๊ณ„๋˜์—ˆ์Šต๋‹ˆ๋‹ค.


Q. ์—ฐ๊ตฌ์˜ ๋ชฉ์ ์€?

๋ณธ ์—ฐ๊ตฌ๋Š” platinum-based chemotherapy์— ๋Œ€ํ•œ ๋‚ด์„ฑ์ด ๋ฐœ์ƒํ•œ ํ™˜์ž๋ฅผ ๋Œ€์ƒ์œผ๋กœ spartalizumab ๋‹จ๋… ์š”๋ฒ•์˜ ์œ ํšจ์„ฑ๊ณผ ์•ˆ์ „์„ฑ์„ ํ‰๊ฐ€ํ•˜๊ณ , PD-L1 ๋ฐœํ˜„ ๋ฐ ๋ฉด์—ญ ๋ฏธ์„ธํ™˜๊ฒฝ๊ณผ์˜ ์—ฐ๊ด€์„ฑ์„ ๋ถ„์„ํ•˜์—ฌ ๋ฐ˜์‘์„ ์˜ˆ์ธกํ•  ์ˆ˜ ์žˆ๋Š” ๋ฐ”์ด์˜ค๋งˆ์ปค๋ฅผ ํƒ์ƒ‰ํ•˜๊ณ ์ž ํ•˜๋Š” 2์ƒ ๋‹จ์ผ๊ตฐ ์—ฐ๊ตฌ์ž…๋‹ˆ๋‹ค.


Q. ์—ฐ๊ตฌ ๋ฐฉ๋ฒ•?

Platinum-based chemotherapy ํ›„ ์งˆ๋ณ‘์ด ์ง„ํ–‰๋œ ์ „์ด์„ฑ ๋˜๋Š” ์žฌ๋ฐœ์„ฑ ์‹๋„ ํŽธํ‰์ƒํ”ผ์„ธํฌ์•” ํ™˜์ž๋“ค์ด ๋“ฑ๋ก๋˜์–ด spartalizumab (3์ฃผ ๊ฐ„๊ฒฉ 300mg) ์น˜๋ฃŒ๋ฅผ ๋ฐ›์•˜์Šต๋‹ˆ๋‹ค. 1์ฐจ ํ‰๊ฐ€ ๋ณ€์ˆ˜๋Š” RECIST v1.1์— ๋”ฐ๋ฅธ objective response rate์˜€๊ณ , 2์ฐจ ํ‰๊ฐ€ ๋ณ€์ˆ˜๋Š” progression free survival, overall survival, safety์˜€์Šต๋‹ˆ๋‹ค. ์ถ”๊ฐ€๋กœ ๋ฉด์—ญ์„ธํฌ ์นจ์œค ๋ฐ PD-L1 ๋ฐœํ˜„ ๋“ฑ ๋ฐ”์ด์˜ค๋งˆ์ปค ๋ถ„์„์ด ๋ณ‘ํ–‰๋˜์—ˆ์Šต๋‹ˆ๋‹ค.


Q. ์—ฐ๊ตฌ ๊ฒฐ๊ณผ?

2020๋…„ 3์›”๋ถ€ํ„ฐ 2021๋…„ 4์›” ์‚ฌ์ด์— 4๊ฐœ ์—ฐ๊ตฌ๊ธฐ๊ด€์—์„œ 44๋ช…์˜ ํ™˜์ž๊ฐ€ ๋“ฑ๋ก๋˜์–ด spartalizumab ์น˜๋ฃŒ๋ฅผ ์‹œ์ž‘ํ•˜์˜€์Šต๋‹ˆ๋‹ค. Objective response rate์€ 20.5%์˜€๊ณ  median progression free survival์€ 3.2๊ฐœ์›”, median overall survival์€ 11.2๊ฐœ์›”์ด์—ˆ์Šต๋‹ˆ๋‹ค.




PD-L1 ๋ฐœํ˜„์ด ๋†’์€ ํ™˜์ž๊ตฐ (TPSโ‰ฅ1%)๊ณผ CD20 ์–‘์„ฑ ๋ฉด์—ญ์„ธํฌ ์นจ์œค์ด ๋งŽ์€ ํ™˜์ž๊ตฐ์—์„œ ๋” ๋†’์€ ๋ฐ˜์‘๋ฅ ๊ณผ ์ƒ์กด์œจ์„ ๋ณด์˜€์Šต๋‹ˆ๋‹ค.






Q. ๋งˆ์ง€๋ง‰์œผ๋กœ ํ•˜๊ณ  ์‹ถ์€ ๋ง์€?

์ด๋ฒˆ ์—ฐ๊ตฌ๋Š” spartalizumab์ด ๋ฐฑ๊ธˆ ๊ธฐ๋ฐ˜ ์น˜๋ฃŒ ํ›„ ์ง„ํ–‰๋œ ESCC ํ™˜์ž์—์„œ ์˜๋ฏธ ์žˆ๋Š” ํ•ญ์•” ํšจ๊ณผ๋ฅผ ๋‚˜ํƒ€๋‚ผ ์ˆ˜ ์žˆ์Œ์„ ๋ณด์—ฌ์ฃผ์—ˆ์Šต๋‹ˆ๋‹ค. ํŠนํžˆ, PD-L1 ๋ฐœํ˜„๊ณผ CD20 ์–‘์„ฑ ๋ฉด์—ญ์„ธํฌ ์นจ์œค์ด ์ค‘์š”ํ•œ ์˜ˆ์ธก ๋ฐ”์ด์˜ค๋งˆ์ปค๊ฐ€ ๋  ๊ฐ€๋Šฅ์„ฑ์ด ์žˆ์œผ๋ฉฐ, ํ–ฅํ›„ ์ด๋ฅผ ๊ธฐ๋ฐ˜์œผ๋กœ ๋ฉด์—ญ ํ•ญ์•” ์น˜๋ฃŒ ์ „๋žต์„ ์ตœ์ ํ™”ํ•  ํ•„์š”๊ฐ€ ์žˆ์Šต๋‹ˆ๋‹ค. ๋ณธ ์—ฐ๊ตฌ๋ฅผ ์ˆ˜ํ–‰ํ•˜๋Š” ๋ฐ ๋„์›€์„ ์ฃผ์‹  ๋ชจ๋“  ์—ฐ๊ตฌ์ž๋ถ„๋“ค๊ป˜ ๊ฐ์‚ฌ๋“œ๋ฆฌ๋ฉฐ, ์—ฐ๊ตฌ๋ฅผ ๊ณ„ํšํ•˜๊ณ  ๋…ผ๋ฌธ์„ ์™„์„ฑํ•˜๊ธฐ๊นŒ์ง€ ๊ต์‹ ์ €์ž๋กœ ์ด๋Œ์–ด ์ฃผ์‹  ํ™๋ฏผํฌ ๊ต์ˆ˜๋‹˜๊ป˜ ๋‹ค์‹œ ํ•œ๋ฒˆ ๊ฐ์‚ฌ ์ธ์‚ฌ ๋“œ๋ฆฝ๋‹ˆ๋‹ค.

mobile background