August 2021: Pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) marka lagu daro platinum iyo fluoropyrimidine kiimoterabiga ku salaysan ayaa waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka ee bukaanada qaba kansarka dheef-shiid kiimikaad ama maxalli ah qalliinka kala-soocidda ama kalamii qeexan
Waxtarka ayaa lagu qiimeeyay xarumaha badan, randomized, tijaabada placebo-koontaroolka KEYNOTE-590 (NCT03189719), kaas oo ku lug lahaa 749 bukaan oo qaba kansarka hunguriga ee dheef-shiid kiimikaadka ama maxalli ah Qalabka PD-L1 IHC 22C3 pharmDx waxaa loo isticmaalay in lagu qiimeeyo heerka PD-L1 ee muunadaha buro ee dhammaan bukaanada. Ilaa inta aan loo dulqaadan karin sunta ama horumarka cudurka, bukaanada ayaa la kala soocay (1: 1) ilaa pembrolizumab oo ay weheliyaan cisplatin iyo fluorouracil ama placebo leh cisplatin iyo fluorouracil.
Guud ahaan badbaadada (OS) iyo badbaadada-horumarka xorta ah (PFS) ayaa ahaa cabirada dhamaadka waxtarka aasaasiga ah, sida uu go'aamiyay baaraha isagoo isticmaalaya RECIST 1.1. (wax laga beddelay si loo raaco ugu badnaan 10 nabarrada la beegsanayo iyo ugu badnaan 5 dhaawac oo la beegsado xubin kasta). Bukaannada loo kala soocay pembrolizumab ee kimoterabiga lagu daweynayay waxay lahaayeen horumar la taaban karo oo xagga OS iyo PFS ah. Dhexdhexaadinta OS ee kooxda pembrolizumab waxay ahayd 12.4 bilood (95 boqolkiiba kalsoonida: 10.5, 14.0), marka la barbardhigo bilaha 9.8 (95 boqolkiiba kalsoonida: 8.8, 10.8) ee cududda kemotherabi (HR 0.73; 95 boqolkiiba kalsoonida: 0.62) 0.86; p0.0001). PFS waxay ahayd 6.3 bilood (95 boqolkiiba kalsoonida: 6.2, 6.9) iyo 5.8 bilood (95 boqolkiiba kalsoonida: 5.0, 6.0), siday u kala horreeyaan (HR 0.65; 95 boqolkiiba kalsoonida: 0.55, 0.76; p0.0001).
Lalabbo, calool-istaag, shuban, matag, stomatitis, daal / asthenia, rabitaanka cuntada oo yaraada, iyo miisaanka oo yaraada ayaa ah waxyeellooyinka ugu badan ee lagu arkay qiyaastii 20% bukaannada helay isku-darka pembrolizumab ee KEYNOTE-590.
Kansarka hunguriga, qiyaasta 200 mg saddexdii toddobaadba mar ama 400 mg lixdii toddobaadba mar ayaa la tilmaamayaa.
Tixraac: https://www.fda.gov/
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