Jazz Pharmaceuticals plc taa mara ọkwa na onye ọrịa mbụ debanyere aha na EMERGE-201, nnwale ụlọ ọgwụ nke Phase 2 na-enyocha nchekwa na ịdị irè nke Zepzelca® (lurbinectedin) dị ka monotherapy na ngalaba atọ nke ndị ọrịa nwere carcinoma urothelial dị elu, nnukwu cell neuroendocrine carcinoma nke ahụ. ngụgụ, ma ọ bụ homologous recombination deficient (HRD) etuto ndị gara n'ihu na usoro nke nwere platinum. EMERGE-201 ga-ebu ụzọ nyochaa ọnụego nzaghachi ebumnobi onye ọrịa (ORR), dị ka Nchọpụta Nzaghachi n'ime Tumor siri ike (RECIST).
"Ọbụna na ọganihu ngwa ngwa na nkà na ụzụ ọgwụ na nlekọta nlekọta n'ọtụtụ ụdị ụbụrụ n'ime afọ iri gara aga, a ka nwere ọtụtụ ndị ọrịa na-aga n'ihu na-egbo mkpa na-enweghị nsogbu ma na-enwe nnukwu ibu nke ọrịa na-anwụ anwụ," ka Arielle Heeke, MD, ara kwuru. ọkachamara n'ọrịa oncologist na Levine Cancer Institute na onye nyocha bụ isi na nnwale EMERGE-201. "Site na nnwale EMERGE-201 na-aga n'ihu ugbu a, anyị na-atụ anya ịhụ mmetụta ahụike Zepzelca nwere na ọrịa kansa siri ike siri ike, gụnyere ọrịa cancer HRD, nke nwere oke nhọrọ ọgwụgwọ akwadoro na-abụghị ọgwụgwọ chemotherapy ọdịnala. Ọnwụnwa a ga-enyocha ma ọ bụrụ na ọgwụgwọ a nwere ike ị nweta nzaghachi etuto dabere na usoro ndu nke ọrịa cancer ndị a yana usoro ọhụrụ nke Zepzelca.
"Mmalite ikpe a bụ ihe dị ịrịba ama na-akpali akpali maka mmemme mmepe ụlọ ọgwụ nke Zepzelca, ka anyị na-achọ iji nyochaa uru ụlọ ọgwụ ya karịa ịgwọ ọrịa cancer akpa ume obere," Rob Iannone, MD, MSCE, onye isi oche onyeisi oche, onye isi nyocha na mmepe nke Jazz kwuru. Ọgwụ ọgwụ. "Nyere Zepzelca na-akpalite ọtụtụ ihe omume nwere ike imetụta ọrụ nke protein na-ejikọta DNA - gụnyere ihe odide ederede na ụzọ mmezi DNA - anyị na-atụ anya nyochaa ọrụ Zepzelca na ọrịa cancer ndị ọzọ siri ike ịgwọ ọrịa ebe a na-edegharị oncogenes ọkwọ ụgbọala na-arụ ọrụ na nrụzi DNA. Usoro adịghị arụ ọrụ, dị ka urothelial carcinoma, nnukwu cell neuroendocrine carcinoma nke ngụgụ na etuto dị mma nke HRD."
Nkọwa ikpe EMERGE-201
EMERGE-201 bụ usoro nke 2, multicenter, na-emeghe akara ngosi nke e mere iji chọpụta nchekwa na ịdị irè nke Zepzelca dị ka monotherapy na ìgwè atọ nke ndị ọrịa nwere etuto siri ike, ndị ga-enweta 3.2 mg / m2 doses nke Zepzelca intravenously n'ụbọchị otu n'ime ha. usoro usoro onunu ogwu kwa izu atọ, ruo mgbe nkwenye ọrịa na-aga n'ihu. Ndị otu atọ a bụ: ndị ọrịa nwere carcinoma urothelial dị elu, nnukwu cell neuroendocrine carcinoma nke ngụgụ, ma ọ bụ etuto HRD ndị nwere ọganihu na usoro nke nwere platinum.
Ebumnuche bụ isi bụ ikpebi ikike Zepzelca iji melite nsonaazụ onye ọrịa, dịka ORR tụrụ ya. Isi njedebe nke abụọ gụnyere onye nyocha nyochara ọganihu n'efu na-aga n'ihu, oge nzaghachi, oge nzaghachi, yana ọnụ ọgụgụ nchịkwa ọrịa dịka RECIST tụlere, yana ndụ zuru oke na ndị sonyere na Zepzelca. Ọ bụ Jazz Pharmaceuticals na-akwado ikpe a.
Ihe dị ka saịtị 20 na US ga-esonye na nnwale a.
