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(๋ฐฉ์žฅํ•œํ…Œ) ๋ฌป์ง€๋„ ๋”ฐ์ง€์ง€๋„ ์•Š๋Š” ๋ฐฉ

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7๐Ÿ–•4โค3
#์•Œ์ง€๋…ธ๋ฏน์Šค

AACR ์ดˆ๋ก ๊ฒฐ๊ณผ

The best overall response rate of CR/PR was 54% (7/13) by mRECIST..."

54ํ”„๋กœ๋ผ๊ณ ??

https://aacrjournals.org/cancerres/article/86/8_Supplement/CT030/783107/Abstract-CT030-A-phase-1b-2a-open-label?searchresult=1
โค6๐Ÿคฎ3
#๋ณด๋กœ๋…ธ์ด EGFR ๋ณ€์ด์™€ C797S๊ฐ€ ํ™•์ธ๋œ ํ™˜์ž 7๋ช… ์ค‘ 6๋ช…์ด partial response(PR)๋ฅผ ๋ณด์—ฌ confirmed ORR์ด 85.7% (!!!)
๋˜ํ•œ ctDNA๋ฅผ ๋ณผ ์ˆ˜ ์žˆ์—ˆ๋˜ 5๋ช… ์ „์›์—์„œ ctDNA ๊ฐ์†Œ๊ฐ€ ํ™•์ธ๋๊ณ , ์ด ์ค‘ 4๋ช…์€ complete ctDNA clearance๊นŒ์ง€ ๋‚˜ํƒ€๋‚ฌ์Šต๋‹ˆ๋‹ค. https://aacrjournals.org/cancerres/article/86/8_Supplement/LB336/782960/Abstract-LB336-VRN110755-A-next-generation-non?searchresult=1
โค6๐Ÿ’ฉ22
Forwarded from Nittany ATOM Land
๋•Œ๋งˆ์นจ FLR ์ง€๋ถ„ ๋ณ€๋™๊ณต์‹œ ๋‚˜์˜ด. ๊ธฐ์กด 7.5%์—์„œ 3.9%๋กœ ๊ฐ์†Œ. ์ดํ‹€๋™์•ˆ ์•ฝ 1,300๋งŒ์ฃผ ๋งค๋„. ๋‚จ์€ ๋ฌผ๋Ÿ‰๋„ ์ผ์ฃผ์ผ ์ด๋‚ด ์ฒ˜๋ถ„ ๊ฐ€๋Šฅ.

https://d18rn0p25nwr6d.cloudfront.net/CIK-0001124198/a42ba459-bb61-414d-9117-3fa660a38ed3.pdf
๐Ÿ‘2
๊ณ„์ขŒ์— SMR, SMU ์ฃผ๊ฐ€๋ฅผ ๋ณด๋Š” ๋‚ด ์‹ฌ์ •
๐Ÿซก169๐Ÿคฃ73
[์•Œ์ง€๋…ธ๋ฏน์Šค/๋กœ์Šˆ ๊ณต๋™๊ฐœ๋ฐœ RZ-001 ์ž„์ƒ 1/2a์ƒ AACR ๊ตฌ๋‘๋ฐœํ‘œ ์ดˆ๋ก ๊ณต๊ฐœ]

4์›” 19์ผ์—๋Š” ์ดˆ๋ก ์ œ์ถœ ๋‹น์‹œ๋ณด๋‹ค ๋”์šฑ ์ง„ํ–‰๋œ ์ž„์ƒ ๊ฒฐ๊ณผ๊นŒ์ง€ ์—…๋ฐ์ดํŠธ๋˜์–ด ๊ตฌ๋‘ ๋ฐœํ‘œ๋  ์˜ˆ์ •

[์œ ํšจ์„ฑ]
RZ-001 ๋ณ‘์šฉ์š”๋ฒ• mRECIST ๊ธฐ์ค€ ORR 53.8%(7/13), ์™„์ „๊ด€ํ•ด CR 23%(3/13)

vs. ๋กœ์Šˆ ์•„๋ฐ”์Šคํ‹ด/ํ‹ฐ์ŽˆํŠธ๋ฆญ mRECIST ORR 35%, CR 12% (IMbrave150 ์ž„์ƒ 3์ƒ)

(ํ™˜์ž ์™„์ „๊ด€ํ•ด(CR) ์ผ€์ด์Šค)
- 2๋ช… 6์ฃผ์ฐจ์— CR, 1๋ช… 30์ฃผ์ฐจ๊นŒ์ง€ CR ์œ ์ง€, 1๋ช…์€ ๋‹จ๋ฐฑ๋‡จ๋กœ ์ธํ•œ ์ค‘๋‹จ ์ „์ธ 18์ฃผ๊นŒ์ง€ CR ์œ ์ง€, 1๋ช… 24์ฃผ์ฐจ PR์—์„œ ์ „ํ™˜๋œ CR ๋‹ฌ์„ฑ

- 12์ฃผ ์ด์ƒ ์น˜๋ฃŒ๊ตฐ์—์„œ ORR 75%(6/8)
- ํ‘œ์ค€์น˜๋ฃŒ ORR 30% ๋Œ€๋น„ ๊ฐœ์„ ํญ 10%p ์ด์ƒ
- ์งˆ๋ณ‘ ํ†ต์ œ์œจ(CR+PR+SD) 92% (12/13)

[์•ˆ์ „์„ฑ]
- DLT(์šฉ๋Ÿ‰์ œํ•œ๋…์„ฑ) ์‹ฌ๊ฐํ•œ ๋ถ€์ž‘์šฉ ๋ฏธ๊ด€์ฐฐ
- 4~5๋“ฑ๊ธ‰ ์ด์ƒ๋ฐ˜์‘/3๋“ฑ๊ธ‰ ์ด์ƒ ๋ฉด์—ญ ๊ด€๋ จ ์ด์ƒ๋ฐ˜์‘ ๋ฏธ๋ณด๊ณ 

https://aacrjournals.org/cancerres/article/86/8_Supplement/CT030/783107/Abstract-CT030-A-phase-1b-2a-open-label?searchresult=1

https://rznomics.com/bbs/?so_table=promote_en
๐Ÿ‘8โค2๐Ÿ–•1
[๋ณด๋กœ๋…ธ์ด VRN11 ์ž„์ƒ 1a์ƒ AACR ํฌ์Šคํ„ฐ ๋ฐœํ‘œ ์ดˆ๋ก ๊ณต๊ฐœ]

๋น„์†Œ์„ธํฌํ์•” mEGFR C797S ํ™˜์ž ๋Œ€์ƒ ์ž„์ƒ 1a์ƒ ์ค‘๊ฐ„์šฉ๋Ÿ‰ ํˆฌ์—ฌ ๊ฒฐ๊ณผ ๋ถ€์ž‘์šฉ ๋ฏธ๊ด€์ฐฐ ๋ฐ ์ฆ๋Ÿ‰๋œ ์ƒˆ๋กœ์šด ์šฉ๋Ÿ‰์—์„œ C797S 3๋ช… ๋ชจ๋‘ PR

๊ธฐ์กด 240mg ๋ฐ์ดํ„ฐ ORR 75%(3/4๋ช…), ๋‡Œ์ „์ด ์™„์ „๊ด€ํ•ด 50%(2/4๋ช…)๋ณด๋‹ค ๋†’์•„์ง„ ORR 85.7%(6/7๋ช…), ๊ณ ์šฉ๋Ÿ‰์œผ๋กœ ๋†’์•„์งˆ์ˆ˜๋ก all PR ์ค‘

[์œ ํšจ์„ฑ]
- ๊ฐ๊ด€์  ๋ฐ˜์‘๋ฅ (ORR) 85.7%(6/7๋ช…)
- C797S ํฌํ•จํ•œ EGFR ๋ณ€์ด๋ฅผ ๊ฐ€์ง„ 7๋ช…์ค‘ 6๋ช… ๋ถ€๋ถ„ ๋ฐ˜์‘(PR)์„ ๋‹ฌ์„ฑ
- ๋ถ„์ž ๋ฐ˜์‘ ํ‰๊ฐ€ ๊ฐ€๋Šฅํ•œ 5๋ช… ๋ชจ๋‘ ctDNA ๊ฐ์†Œ ๋ฐ 4๋ช… ctDNA ์™„์ „ ์ œ๊ฑฐ

[์•ˆ์ „์„ฑ]
- 480mg๊นŒ์ง€ DLT ์šฉ๋Ÿ‰์ œํ•œ๋…์„ฑ ๋ฏธ๊ด€์ฐฐ
- ํƒ€๊ทธ๋ฆฌ์†Œ(์˜ค์‹œ๋จธํ‹ฐ๋‹™) ์•ˆ์ „์„ฑ ํ”„๋กœํŒŒ์ผ์— ๋น„๊ตํ•ด ์›”๋“ฑํžˆ ์œ ๋ฆฌํ•œ ์•ˆ์ „์„ฑ ํ”„๋กœํŒŒ์ผ
- PK ๋ถ„์„ ๊ฒฐ๊ณผ, 160mg๋ถ€ํ„ฐ EGFR ๋ณ€์ด์— ๋Œ€ํ•ด ํ˜ˆ์žฅ ๋†๋„๊ฐ€ IC90์„ ์ดˆ๊ณผํ•˜๋Š” ์šฉ๋Ÿ‰ ๋น„๋ก€ ์ „์‹  ๋…ธ์ถœ (160mg ์šฉ๋Ÿ‰๋ถ€ํ„ฐ ํ™˜์ž์˜ ํ˜ˆ์•ก ์† C797S ๋ฅผ 90% ์ด์ƒ ์–ต์ œํ•˜๋Š” ๋ฐ ํ•„์š”ํ•œ ๋†๋„(IC90)๋ฅผ ๋„˜๊ณ  ์žˆ๋‹ค๋Š” ์˜๋ฏธ)

https://aacrjournals.org/cancerres/article/86/8_Supplement/LB336/782960/Abstract-LB336-VRN110755-A-next-generation-non?searchresult=1
๐Ÿ‘5โค2๐Ÿ–•1
์•Œ์ง€, ๋ณด๋กœ ๋‘˜๋‹ค ์ข‹์€๋ฐ ๋ญ๊ฐ€ ๋” ์ข‹์€์ง€ ํŒ๋‹จ์€ ๊ฐœ์ทจ์ธ๋“ฏ

์ƒˆ๋กœ์šด ํ”Œ๋žซํผ ํƒ„์ƒ - ์•Œ์ง€๋…ธ๋ฏน์Šค
๊ธ€๋กœ๋ฒŒ ๋น…๋”œ ๊ฐ€๋Šฅ์„ฑ - ๋ณด๋กœ๋…ธ์ด
โค14๐Ÿ–•7
RZ001 RECIST๋ƒ mRECIST๋ƒ ๋ง์ด ์žˆ๋Š”๋ฐ ์• ์ดˆ์— mRECIST๊ฐ€ HCC์—์„œ RECIST ์ธก์ •์ด ์ž‘๋™์„ ์•ˆ ํ•˜๋Š” ์ผ€์ด์Šค ๋•Œ๋ฌธ์— AASLD์—์„œ ๊ฐ€์ด๋“œ๋ผ์ธ์„ ๋ฐœํ‘œํ•œ ๊ฑฐ๋ผ... mRECIST๋กœ ๋ณด๋Š” ๊ฒŒ ๋งž์Šต๋‹ˆ๋‹ค

FDA๋‚˜ EMA๋Š” Regulatory ๊ธฐ๊ด€์ด๊ธฐ์— ๊ฐ„์—์„œ๋งŒ ๋”ฐ๋กœ mRECIST๋ฅผ ๋—ด์–ด์„œ ๋ณด์ง„ ์•Š์Šต๋‹ˆ๋‹ค. ์ด๊ฑด ์–ด๋–ค ๊ณ ํ˜•์•”์—์„œ๋„ ๋งˆ์ฐฌ๊ฐ€์ง€๊ตฌ์š”.

hepatology์—์„œ ์–‘๋Œ€ ์‚ฐ๋งฅ์ธ AASLD๋ž‘ EASL ๋ชจ๋‘ mRECIST๋ฅผ ํ‘œ์ค€์œผ๋กœ ์‚ผ๊ณ  ์žˆ๊ณ , mRECIST ์—†์ด๋Š” ๋ฐ์ดํ„ฐ ๋…ผ์˜ ์ž์ฒด๊ฐ€ ๋ฌด์˜๋ฏธํ•˜๋‹ค๊ณ  ๋ณด์‹ฌ ๋ฉ๋‹ˆ๋‹ค
๐Ÿ–•4๐Ÿ‘3
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์ „๋ฐฉ์— ํ•จ์„ฑ ๋ฐœ์‚ฌ!!!
๐Ÿ‘4๐Ÿ–•3
.
โ–  ์†๋„๋Š” ๋‚ฎ์ง€๋งŒ ์ƒ์„ ์˜ ์ •์ƒ ํ†ต๊ณผ๊ฐ€ ์ง„ํ–‰๋˜๊ณ  ์žˆ๋Š” ๊ฒƒ์œผ๋กœ ๋ณด์ž…๋‹ˆ๋‹ค.

#ํ˜ธ๋ฅด๋ฌด์ฆˆ
โšก9๐Ÿ–•5โค1๐Ÿ‘1
#์‚ผ์„ฑ์ด์•ค์—์ด (์‚ผ์„ฑE&A) #์‚ผ์„ฑ์ „์ž

์‚ผ์„ฑ์ „์ž ํ‰ํƒ์บ ํผ์Šค P5 ๊ณต์‚ฌ ๊ณ„์•ฝ๊ธˆ์•ก 3.41๋ฐฐ ์ฆ๊ฐ€

5500์–ต โž” 1์กฐ 8790์–ต
โค5
์œ ์กฐ์„ ์— ์ด๋ ‡๊ฒŒ ํ•˜๋ฉ”๋„ค์ด ์ดˆ์ƒํ™”๋กœ ๋„๋ฐฐํ•ด๋†“์œผ๋ฉด ์ด๋ž€๋„ ๋ชป๊ฑด๋“ค๊ฑฐ ๊ฐ™์€๋ฐ
โค43๐Ÿ˜1