24.05.09 () 08:58

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۷ι ӻ ġ
2023-10-31 05:50:45
۷ι ӻ ġ
2023-10-31 05:50:45
[DP ͺ] ö Ϻ ϼ

+긮Ʈ 'MARIPOSA' ӻ Ÿ׸ ܵ ȿ Ȯ

" EGFR 1 ġ ڸ "


߹ : DPͺ
߱ȹ : ̿2
Կ : 󴺽
⿬ : ö Ϻ ϼ

[ϸ= ] ֱ ȸ мȸ(ESMO 2023) MARIPOSA ӻ3 ߰̽ϴ. EGFR ҼϿ Ѿ (и Ƽ) Ἶ 긮Ʈ(ƹ̹Ÿ) ȿ ǥġ ƽƮī Ÿ׸ ܵ ε.

̹ ΰ ȿ ߴ, 뿡 ġ ߴٶ ֽϴ. ๰ Ÿ׸(øƼ)+ ׾ȭп 񱳵 Ǹ鼭 MARIPOSA ӻ ̸ ߵǰ ִ ȲԴϴ.

MARIPOSA ӻ ֵϽð ̹ ESMO 2023 ͸ ǥϽ ö Ϻ ϼ(系) ̹ ӻ Ǹ ýϴ.

Q. ̹ ESMO 2023 ڿ 긮Ʈ ȿ MARIPOSA Ұ Ź帳ϴ

MARIPOSA ӻ3 Ƹ EGFR 4 ҼϿ ׵ ƴ Ը ū Ͻø ˴ϴ.

ġ EGFR 4 Ҽ ȯڸ ڿ 긮Ʈ ( ) Ÿ׸ ܵ 1 1 ӻ3 Դϴ.

ܵ ־µ ƴϾϴ. ܵ  긮Ʈ ⿩(contribution component)  Ȯϱ ̾ϴ.

1 򰡺 Ÿ׸ ܵ Ⱓ(PFS) 񱳿ϴ. 2 򰡺 ü(OS) Եƽϴ.

(positive)̾ϴ. PFS 23.7, Ÿ׸ ܵ 16.6 ӻ ̸ ϴ. Ǵ 30% Ÿ׸ ܵ 7.1(밪) PFS ̰ Ÿϴ.

߿ϰ κ MRI Կ Ƚ Դϴ. Ÿ׸+ ׾ȭп ȿ FLAURA2 ȯڸ MRI ʾҽϴ.

MARIPOSA ȯڵ MRI, CT Կ ̾ ݵ 8ַ ªҽϴ. ̸ ȯڵ Ȯ ־ 1 򰡺 PFS ª Ÿϴ.

̸ ̿ õ ΰ(Extracranial) PFS ߾Ӱȸ(BICR) ߴµ, Ÿ׸ ܵ PFS 9 Ȯ߽ϴ. PFSӸ ƴ϶ ӱⰣ(DOR) (CR) Ÿ׸ ܵ ҽϴ.

ϳ ߿ ȯںе PFS ŭ ߿ϰ ϴ OS ⼺ ϴ. (ǥ) OS ġ Ű ϰ ֽϴ.

Q. ֱ 3 EGFR-TKI ȿ 򰡸 ϰ ִµ. MARIPOSA Ź帳ϴ

MARIPOSA ӻ EGFR 3 Ÿ̷ν Ű (TKI) ü 50% ˷ EGFR MET ̸ ϱ ̸ ǥ ִ 긮Ʈ ȿ ϴ Դϴ.

ܼ PFS, DORӸ ƴ϶ ( ʿϰ) OS ⼺ ٴ ߿մϴ.

׾ġḦ ϸ ¿ ϴ. ȯڵ ִ, ׸ ǻ ͼ ߿մϴ. () κ EGFR õ Դϴ.

( ۿ) Ǻ ̳ ̱ Ƿ ׵ 20 Ѱ EGFR ǥġ 鼭 ְ ϴٰ 򰡵˴ϴ. ȯ, ǻ ؼ ̰ܳ ֽϴ. ̷ 鿡 ִٰ 帱 ְڽϴ.

Q. 2 򰡺 ü ⼺ Ÿϴ.  DZ?

Ӹ ƴ϶ Ư EGFR (Ҽ) ܹް ηϴ ġ ȯڵ ؼ OS (benefit) ֱ⸦ Ҹϰ ֽϴ.

10 Ѵ Ⱓ ƽϴ. ǥ Ϲ ׾ , ƹٽƾ(ٽָ) ؼ Ȯ PFS ־ϴ.

(ٸ ͸ Ȯ ) PFS Ű ȯڰ ֳ 鿡 и ̸ ʾҽϴ.

׷ ߰(interim) OS м, ⼺ Ѻ ǰ ؾ ȴٰ ϰ ֽϴ.

Q. 1 򰡺 PFS ġ 뺸 ʾҴٴ ǰߵ ־ϴ

װ ο ؼ 𸣱 Ͼ Դϴ. ⺻ ؾߵǴ ο ° ֿ 򰡺 ׳Դϴ. (MARIPOSA ) Ÿ׸ ܵ ߿(significant) ߳ ϸ װ и ½ϴ.

ٸ ذ κ Ÿ׸+ ׾ȭп FLAURA2 񱳿Դϴ. Ÿ׸ҿ Ϲ ׾ȭп PFS ú MARIPOSA PFS Ⱓ ª ʴ ϴ ε ̴ ٸٰ 帱 ְڽϴ.

(MARIPOSA ȯڸ MRI ݸ) Ÿ׸ ȯڿ Ӹ MRI ʾҽϴ. ̰ Ȯε ȯ 30~40% ȯڸ MRI Կ߽ϴ.

(MRI Կ ȽӸ ƴ϶) CT Կ MARIPOSA ξ մϴ. ӵθ ޸ ( ӵ ϱ ) ǵ ġ ġ MARIPOSA Ͻø ǰڽϴ. ׷ 翬 Ȯ ۿ PFS ҷ ̾ ۿ ˴ϴ.

ٸ ׷ ҽĽŰ ؼ ΰ(Extracranial) PFS и ٸ ϰ PFS ߾Ӱ 27.8̾ϴ. ̴ FLAURA2 Ÿ׸+ ׾ȭп 9 ̿ϴ.

̴  () PFS Դϴ. ó ̷ Ȯ ο ذ ª ¿ ʷ Ʊ ̷ ( 뺸 PFS ġ Ҵٴ ) Դ ̷ 帱 ְڽϴ.

Q. ġ ϴ ۿ Ǵ Դϴ. ̹ ӻ󿡼 ۿ Ÿµ. ?

MARIPOSA ļ ġ(subsequent therapy) մϴ. 籺 30% ȯڰ ġḦ ޾ҽϴ. ᱹ ļ ġḦ 󸶳 ޴İ OS ۿ ϴ.

߿ ļ ġ Ÿ׸ ʾҴٴ Դϴ. Ϲ ׾ġḦ ޾Ұ EGFR-TKI ܵ ġḦ ޾ҽϴ.

30% ȯڰ 籺 ļ ġḦ ޾ҽϴ. װ Ϲ ׾ ļ ġ и ̸ Ÿ Դϴ. ⺻ ȯڵ ޴  ̳ ۿ ļ ġῡ ġ ʴ´ٴ Դϴ.

° ۿ κ ͼ ۿ̶ Դϴ. ( ߻ ۿ) Ǻι̳ չ鿰 20 ؿԱ () ϴٴ Դϴ. (supportive medicine) ֽϴ.

° ۿ κ 1~2̶ Դϴ.  ü (3 ̻ ۿ) 75% ƴµ װ ๰ ߻ ̻(Treatment-emergent adverse event, TEAE) ġԴϴ. ġ ̻(Treatment-related adverse event, TRAE) 3~4 ۿ ʾҽϴ.

̹ Ӱ ߰ߵ ۿ (VTE)ε κ ̰ 4 (anticoagulation) ȿ մϴ. ̷ ۿ ȯ, Ƿ ̰ܳ ִٰ 帱 ְڽϴ.

Q. 汸 3 TKI ֻ ϰ Ǹ ȯ 湮 , پ ž Դϴ. ȿ ִٰ ϽDZ?

̹ ǥ PFS, 2 Ⱓ(PFS2), DOR ȿԴϴ. εǰ ޿ Ҽ ȯڿ 100% ̶ ֳ ϸ ͷδ ׷ ֽϴ.

ȯڿ ȣ (preferred regimen) DZ ؼ OS ؾ ϰ 밨 ϴ.

ٸ °ġ ӻ ͷ (EGFR Ҽ 1 ġ) ȴٸ ȯڵ ؼ Ǹ ؾ ˴ϴ. PFS PFS2 ε ȯڿ ġ ֱ ̷ 帳ϴ.

Q. EGFR Ҽ 1 ġ ó Ʈ尡 ٲ ̶ ϽDZ?

(EGFR Ҽ ġῡ) ܵ ǥġ(SoC) ᱹ ܵ , (old) ǥġ ۿ ϴ.  ȯڵ鵵 Ⱓ ª 13 16~18 Դϴ. 2 Ǵ Ⱓ̰ŵ.

׷  ȯڵ (Quality of life, QoL) ų ִ, ο  ִϴ õ ؾ մϴ. ϳ 帶ũ MARIPOSA ϴ. ڰԵ ͸ ½ϴ.

ȯڵ Ű ϴ ׷ 뿡 ϰ ְ и Ŵ (EGFR Ҽ 1 ġ) ڸؾ Ѵٴ Դϴ.

( ȿ ) ȯڵ ƾ DZ Դϴ. MARIPOSA ׷ ´ٰ ϰ ֽϴ.
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 05)
౹ 71
ǰ ְ
ѽŻ÷(10) 3,500 2,300 1,200 3,028
޾(100) 25,000 22,000 3,000 23,304
Ʒγΰ(100) 30,000 27,000 3,000 29,237
īɾ(10g) 8,000 5,500 2,500 6,472
Ľõ򿬰(5g) 5,500 4,000 1,500 5,035
Ź(4) 5,000 3,500 1,500 4,449
ڶ(20) 7,000 5,800 1,200 6,433
(10) 6,000 4,000 2,000 4,914
Ժ(10) 4,000 3,000 1,000 3,543
ڱ׸(20) 5,000 3,800 1,200 4,622
ť(10) 3,500 2,300 1,200 2,828
Ȱť(1) 1,200 1,000 200 1,140
Ǯɾ(3.3ml) 25,000 22,000 3,000 24,214
޵𿬰(10g) 7,000 5,000 2,000 6,162
öŸ(34) 13,000 10,000 3,000 12,089
뽺ī(20g) 22,000 18,000 4,000 20,358
ġ(1) 1,100 1,000 100 1,000
ӽ÷(21) 10,000 7,500 2,500 8,998
ͺ(10) 3,500 2,300 1,200 3,138
ݿ(1ڽ) 3,000 2,500 500 2,947
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,973
߽Ÿ(120) 70,000 40,000 30,000 54,203
Źĸ(10ĸ) 3,000 2,000 1,000 2,941
Ÿ̾(120) 60,000 40,000 20,000 49,168
տ(60ĸ) 30,000 24,000 6,000 27,235
Ÿ̷ER(6) 2,500 2,500 0 2,500
ٿ(30g) 12,000 9,000 3,000 11,221
(120) 25,000 18,000 7,000 21,716
Ʒ(6) 4,000 3,000 1,000 3,509
ǽõĸ(270ĸ) 120,000 85,000 35,000 106,875
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׳(10) 3,000 2,000 1,000 2,684
6̺(10) 3,500 2,000 1,500 2,965
(60) 250,000 200,000 50,000 224,000
Ⱦ 12,000 9,000 3,000 10,494
̰źĸ(60ĸ) 25,500 22,000 3,500 23,942
Ųť(20) 5,500 4,500 1,000 4,823
λ絹÷(100) 37,000 29,000 8,000 31,878
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