߹ : ȱ ̿
߱ȹ : Ȱ
Կ :
: Ϻ ϼ áȫ
Ȱ: ȳϼ. ϸ Ȱ Դϴ. ð ̾ ð ̱ӻȸ(ASCO 2021) мȸ ٽ ¤ ð ڽϴ. ð ̾ Ϻ ϼ ȫ, Բ ϰ ʴϴ.
áȫ: ȳϼ, ݰϴ.
Ȱ: Ȥö ASCO 2021 䡯 1 ̴ٸ Բ ûֽñ õ帱. 1 ƴ ó EGFR(Ǽڼü) ̸ Ÿϴ ǥ ͵ ̹ ASCO ǥǾ. Ե鲲 ӻ ǹ̸ Ͻð ϴ.
Ʒ ŬϽø 'ASCO 2021 -1' ˴ϴ.
'' ӻ غ
캸 Ϻ ɴٰ Ƽ(mobocertinib) Ͱ ̹ ASCO ҰǾ, 4 ̱ǰǾ౹(FDA) 켱ɻ ޱ ߴµ. Ե鲲 Ƽա ӻ ̴ ñմϴ.
ȫ: Ƽա̶ EGFR ߿ 10% ϴ (exon) 20 (insertion) ǥϴ Դϴ. TAK-788̶ ڵ ˷µ ֱٿ Ƽա̶ и Ҹ . ۳ 4 FDA ġ (breakthrough therapy designation) ҽϴ.
ASCO ݱ EGFR 20 ȯ 114 Ƽա 160mg ǥƽϴ. ü (ORR) ȸ(IRC) 28%, ڰ 35% Ÿ. (DCR) ȸ 78% ƽϴ. Ⱓ(PFS) ߾Ӱ 7.3, ü Ⱓ Ե 2 ߾Ӱ Ÿ½ϴ. ӱⰣ(DoR) ߾Ӱ 18 . ̷ ȯڿ ǥؿ ̰ ִ Ź 鿪 ó 5-10% ġ ִ Դϴ. Ⱓ 3 ǰ. Ƽա EGFR 20 ȯڿ Ź ȿ ̴ ְڽϴ. ð ٷ 극Ʈ(и ƹ̹Ÿ) 40%, Ⱓ 8.3, üⰣ 22 ϴ.
̹ ASCO 2021 'Ƽ' м Ұƴµ, EGFR 20 ̿ 30 ̻ (subset) ϰŵ. Ƽա 20 ȿ Ÿ½ϴ. EGFR ǥ ϰ Ǵ Ǻι, չ ̻ ƴµ, 3ܰ ̻ ̻ 簡 20% ̾, 5% ̳ 뷮 Ǵ ٸ ٰ̾ ƽϴ. ̹ Ƽա EGFR 20 ̸ ġῡ ġɼ ̶ Ǵܵ˴ϴ.
Ȱ: ӻ 캼 ȿ ϴ 찡 ŵ. 忡 ȯڵ ӻ Ե ְ ô ƿ. ֱ FDA 㰡 극Ʈ Ͷ ϼ̴µ, ȭ ó?
ȫ: , 극Ʈ ȿɰ ٰ ˴ϴ. FDA Ǹ㰡 ϴ.
: Ư غ ȯںе ϷƲ ð ƴݾƿ. Ư ̷ EGFR ǥ ȯڵ ϻȰ ϸ鼭 ϴ 汸̱ , ༺ ߿ϰ մϴ. ϸ ȯڵ ϱ ŵ. ӻ Ͱ ǥ ؼ ϴ Դϴ.
Ȱ: , մϴ. ֱٿ ġ о߿ ž ϰ ִٴ ݰ ҽԴϴ. EGFR 20 оߵ , KRAS ̸ Ÿϴ ǥ ħ ȭ . ǡʡ̶ 縶ũ ǰ FDA 㰡 ҽϴ. KRAS G12C ̸ ༺ Ǵ ̼ Ҽ ȯڰ ̴. װ KRAS ǥ 㰡 ̹ óε, ̹ ASCO KRAS Ͱ ټ ǥƴٰ ϴ.
: , KRAS ̴ ˷ ұϰ ڱ Ư ߵ ϴ Ȳ̾ϴ. ֱ KRAS ߿ G12C Ư ̸ Ÿϴ 鼭 ߵǰ . EGFR ̴ ο ٰ ˷? ݸ KRAS ε鿡 ϴ ̿. ü KRAS 25% ǰ. KRAS G12Cδ 翡 13%, ѱ ƽþƿ 5% մϴ. ġ ʴٰ µ, ALK, ROS1 5% ̰ŵ. ġ ̶ ϱ ϴ. EGFR ̿ KRAS Ҽ ܹ ȯڵ ġɼ ߰ ȯҸ .
KRAS ǥ ڴ ʡ ̶Ƽǻƽ ƴٱʡ 2Դϴ. ̹ ASCO ʡ 2ӻ CodeBreak100 ƴٱʡ 3ӻ KRYSTAL-12 (trial-in-progress) Ұƽϴ. CodeBreak 100 캼? ش ġḦ ް KRAS G12C Ҽ ȯ 120 ʡ 960mg м߽ϴ. ӻ ȯ 80% ̻ ݱ ȭп Ǵ 鿪 ŷ ־ϴ.
15.3 , ʡ ȯڴ 37.1% (ORR) ϴ. (DCR) 80.6% ߰, Ⱓ(DoR) ߾Ӱ 11.1̾ϴ. Ⱓ(PFS) ߾Ӱ 6.8, ü Ⱓ(OS) ߾Ӱ 12.5 ƽϴ. ̷ ȯڿ ǥ ʾ Ͱ 6 ̸ Ұ ̰ŵ, 鿡 Ⱓ . ٸ ϴ (head-to-heda) 3ӻ Ѻ ʿ ϴ.
Ʊ 帰 ó ൵ ȯڵ Դ ̶ DZ մϴ. ʹ ϸ ȯڵ ô 찡 ŵ, 캸 ġ ̻ 70% ȯڿ ߴµ κ 1~2 ̾ϴ. ȯڿ ̸ ̻ ν ̶̻ ø ˴ϴ. CodeBreak100 غ ʡ ġ ִ KRAS G12C Ҽ ȯڸ ο ӻ ߴٰ ְڽϴ.
Ȱ: Բ Ұֽ KRAS ǥ ڷ ʡ ܿ ƴٱʡ̶ ־? ̶Ƽǻƽ 忡 () FDA 㰡 ȭ θ . ƴٱʡ ؼ ϼ?
: ƴٱʡ ؼ ֱ Ͽȸ(IASLC) ַ ۷(WCLC) KRYSTAL-1 Ͱ ǥ ֽϴ. ġῡ KRAS G12C 缺 ȯ 2ġ , Ÿ ȯڱ '' մϴ. ƴٱʡ 600mg Ϸ 2ȸ ϴ ߽ϴ.
Ȱ: Ⱓ KRAS ǥ ߵ ߴ ſ ſ ٸ ġ ȯڵ ǰ?
: , ϴ. 1ġ ݻǰ μ 2,3μ ȿ ܰԴϴ. (ORR) 40%ٴ ̶ ˴ϴ. ̹ ASCO 2021 ǥ trial-in-progressͷ KRYSTAL-12 Ȳ Ȯ ִµ, ǥġ Ź ƴٱʡ (head-to-head) 3 ӻ Դϴ.
Ȱ: KRAS о߿ ο ǥ Ӽ ϸ鼭 ȯڵ ġ ˴ϴ. ǥ ŭ̳ ġῡ ߿ ϰ 鿪 Ǹ . ASCO мȸɵ, ŰƮ١ 鿪 Ͱ ó ̼ߴٴ ı⸦ ŵ.
ֱٿ ̷ 鿪 پ Ȱϰ õǰ ִ ϴ. ASCO 2021 ǥ ͵ غ ش 鿪 Ͽ(adjuvant) Ȱϱ Ϳ ̴߰.
ȫ: ϴ. ҼϿ 鿪 ַ Ұ 3~4 ȯ Դϴ. 츮 ǰ ִ . 鿪 ӻ ټ õǾ Դµ, ̹ ASCO 2021 3ӻ Ͱ ó Ǹ鼭 ҷ ҽϴ.
Ұ帱 IMpower-010 Դϴ. ǥ Ͽ 4ֱ(cycle) ȯڸ νǡƼƮ(и ָ) ƹ ġᵵ (Best Supportive Care, BSC), 2 . 1 ǥ ڰ Ǵ Ⱓ(DFS)Դϴ. PD-L1 ִ 2~ 3A ȯڸ ü 2~ 3A ȯ, ư 1B~ 3A ȯڱ ܰ DFS θ 캸 ƽϴ. 32 , PD-L1 ִ 2~ 3A ȯڿ 赵 34% ߽ϴ. PD-L1 ο ü 2~ 3A ȯ 赵 21% ߰, ǹ߽ϴ. 2 61% ȯڰ ʾҴµ, PD-L1 缺 Ұ ƼƮ 75%, PD-L1 70% ȯڰ ʾҽϴ.
PD-L1 ο ü ȯڱ 19% 赵 Ұ Ȯεƴµ ǹ ʽϴ. ٸ ߰м̱ Ⱓ þ鼭 ɼ ִٰ ˴ϴ. 2 ü (OS) ڷ ϼ ܰε. Ⱓ ̻ƼƮ 92.7%, 70.7% ƽϴ. ٸ 3 ̻ ̻ ƼƮ 21.8%, 11.5%, ǥƴ ټ ƼƮ Դϴ. ü Ⱓ Ͱ ϰ, ʱ ܰ Ҽ ȯڿ 鿪 Ͽ ִٴ ù ° ӻ Ͷ ûϴ ٰ Ůϴ.
Ȱ: 鿪 Ȱ о ִ ƿ. ̻ ȯ ַ ƴٸ, ̷ Ͱ Ǹ鼭 ʱ ȯڿ ٰ ϸ ǰ?
ȫ: , ٵ. ʱ ȯڸ Ѵٸ 2, 1ġ ñⰡ մ, 1ġ ϰ Ͽ õϰ Ǵ .
̱ȸ(AACR) Ǵٸ 鿪 ɵ Ͽ CheckMate 816 ӻ Ͱ ǥDZ ߽ϴ.
Ȱ: 鿪 Ȱ о ٽѹ ǰϰ ˴ϴ. 鿪 , ¼ ߵǴ PD-1 ŭ ٴ . CTLA-4 ̡(и ʸ) ο ӻ Ͱ ̹ ASCO 2021 Ⱓ ǥƽϴ. CheckMate 9LA 2 Ϳ Checkmate 277 2 ˰ ִµ, Բ Ұֽø ?
: Ͻ ó ̡ о߿ ε巯 ߾. ASCO ȯ ̡ CheckMate 9LA 2 CheckMate 227 4 2 ӻ Ͱ ǥƽϴ.
CheckMate 9LA 캼. CheckMate 9LA 700 4 ȯڸ ġ , 3ӻԴϴ. ȯڸ 쿡¡ɵ ̡, ġḦ ߰, 쿡 ǥ ȭп 캸 ̷. Ư ɵ ̡ , ȭп ȯڱ 2ֱ⸸ ߴٴ Դϴ. Ϲ ȭп 4ֱ Ǵ ̻ ϴµ, 2ֱ⸸ ߴٴ ̻. ȿδ üⰣ(OS) ýϴ.
2Ⱓ , ɵ+̡ ձ OS 15.8, 11 ǹ ̸ Ÿ½ϴ. ɵ+̡ ձ 赵 30% ҽ. ۳ ASCO Ϳ ϸ 赵 ٱ ߽ϴٸ, ɵ+̡ ձ ߾ 15 ̻ ǰ . ָ 鿪 ̿Ŀ Ǵ PD-L1 ȯڱ 17.7̶ ٴ Դϴ. پ (Subgroup) м 赵 캻 , PD-L1 , , ߽Ű(CNS) ο ϰǰ ǥ ȭп 赵 ߴ ϴ.
츮 ġῡ Ȱ ִ پ ġɼ ʽϱ. ȯڿ ´ ġ ؼ óϴ ǵ ߿ ӹ. 1ġῡ Ȱ ִ Ⱑ þ ִ ȯڿ ǻ ο ٶ ȭ ˴ϴ.
Ȱ: ټ ҿܵǾ ־ ̡ ߰ߵǴ Ⱑ ƿ. Checkmate 277 ͵ Ұֽø ?
: CheckMate 227 4⵿ Ͷ ǹ̰ Ůϴ. ɵ+̡ 3 Ϳ ϰǰ ġ ְ ־. 4 ȯڸ 4 캻ٴ ü ̾ŵ. ̹ PD-L1 1% ̻ ȯڿ ɵ+̡ 30% ߽ϴ. ȭп 10% , 30% ȯڰ ִٴ ġԴϴ. PD-L1 1% ̸ ȯڿ 24% Ÿ½ϴ.
鿪 ϴ ū ϳ ̷ ϱ ̰ŵ. 鿪 巯 Ͷ ˴ϴ.
Ȱ: Ϲε ӻ ġ ١ ѱ ƿ. ó Ѻ Ұ ص ܹ 뿩 Ұϴٰ Ƶ鿩 ʾҽϱ. 鿪 ȯڸ 4Ⱓ ӻͰ Ȯƴٴ ü ƴѰ ϴ ϴ. ڵ ̿ ƿ.
ڷγ19 ASCO 2121 мȸ ֵ ƽ, ȫ Բ ASCO 2021 ǥ ٽɸ ¤ֽ п 忡 ٳ ̻ ð ƽϴ. ð , Կ ASCO 2021 ȸ Ŀ. в ȸ ڸ û е ӻ ּ̰ŵ. ڸ ٽ ѹ 帳ϴ. ûںе鲲 Բ λϸ鼭 ϰڽϴ.
Ȱáȫ: մϴ.