Ngwa ọgwụ ọhụrụ maka ọgwụgwọ ọrịa kansa akpa ume na-abụghị obere cell

CStone Pharmaceuticals, ụlọ ọrụ biopharmaceutical lekwasịrị anya na nyocha, mmepe, na azụmaahịa nke usoro ọgwụgwọ immuno-oncology ọhụrụ na ọgwụ ziri ezi, kwupụtara taa na ngwa ọgwụ ọhụrụ (NDA) maka pralsetinib maka ọgwụgwọ nke emegharịrị n'oge mbufe (RET) ngwakọta-nke dị mma na mpaghara. anabatara ọrịa cancer akpa ume na-abụghị obere cell ma ọ bụ metastatic na Hong Kong, China.

Pralsetinib bụ ihe mgbochi RET nwere ike ma họrọ nke onye mmekọ CStone ọgwụ Blueprint chọpụtara. CSstone nwere mmekorita ya na nkwekọrịta ikike ya na ọgwụ Blueprint maka mmepe na azụmaahịa nke pralsetinib na Greater China, nke gụnyere Mainland China, Hong Kong, Macau na Taiwan.

Dr. Jason Yang, Chief Medical Officer nke CSstone, kwuru, sị, "Anyị nwere nnọọ obi ụtọ na NDA nke ọzọ innovative ọgwụgwọ nkenke, pralsetinib, na-anabata maka ọgwụgwọ nke elu RET fusion-positive NSCLC, mgbe AYVAKIT® (avapritinib) kwadoro. maka ọgwụgwọ nke na-adịghị edozi ma ọ bụ metastatic PDGFRA D842V mutant gasstromal tumors na Hong Kong, China na December 2021. N'ime usoro 1/2 ARROW zuru ụwa ọnụ, pralsetinib gosipụtara uru ụlọ ọgwụ na-adịgide adịgide na profaịlụ nchekwa nchekwa na-anabatakarị na ndị ọrịa nwere njikọ RET. NSCLC dị mma na mpaghara dị elu ma ọ bụ metastatic. Anyị na-atụ anya nnabata nke pralsetinib na Hong Kong, China iji nyere aka rite uru karịa ndị ọrịa ngwa ngwa o kwere mee. "

Nnabata NDA nke pralsetinib na Hong Kong, China dabere na nsonaazụ sitere na usoro ọmụmụ 1/2 ARROW zuru ụwa ọnụ. Emebere nnwale a iji nyochaa nchekwa, nnabata, na ịdị irè nke pralsetinib na ndị ọrịa nwere RET-fusion positive NSCLC, RET-mutant medullary thyroid cancer (MTC), na etuto siri ike ndị ọzọ nwere RET fusions.

Nsonaazụ sitere na nnwale ARROW na ndị ọrịa zuru ụwa ọnụ nwere nnukwu RET fusion-positive NSCLC gosipụtara na Nzukọ Kwa Afọ 2021 American Society of Clinical Oncology (ASCO) na June 2021. Dị ka ụbọchị nkwụsị ụbọchị nke Nọvemba 6, 2020, pralsetinib gosipụtara ụlọ ọgwụ na-adịgide adịgide. Uru na ndị ọrịa nwere NSCLC RET fusion-positive bụ ndị nwere ọrịa a na-atụ aro na mbido wee nata ọgwụ mbido 400 mg otu ugboro kwa ụbọchị.

• N'ime ndị ọrịa 68 na-agwọ ọrịa-naïve, ọnụ ọgụgụ nzaghachi zuru ezu (ORR) bụ 79 pasent (95% CI: 68%, 88%). Nzaghachi zuru oke (CR) bụ pasent 6, pasent 10 nke ndị ọrịa nwere nlọghachi azụ nke etuto a tụrụ anya ya, na pasent 74 nke ndị ọrịa nwere nzaghachi nke ọma (PR). Ogologo oge nzaghachi nke etiti (DOR) eruteghị (95% CI: ọnwa 9.0, erubeghị).

• N'ime ndị ọrịa 126 bụ ndị natara mbụ chemotherapy dabeere na platinum, ORR bụ 62 pasent (95% CI: 53%, 70%). Ọnụego CR bụ pasent 4, pasent 12 nke ndị ọrịa nwere nlọghachi azụ nke etuto a tụrụ anya, na pasent 58 nke ndị ọrịa nwere PR. Nke etiti DOR bụ ọnwa 22.3 (95% CI: ọnwa 15.1, erubeghị).

• Dị ka ụbọchị nkwụsị data, ngụkọta nke ndị ọrịa 471 debanyere aha n'ofe ụdị etuto nwere ọgwụ pralsetinib na-amalite na 400 mg otu ugboro kwa ụbọchị. Ihe omume ọjọọ metụtara ọgwụgwọ kachasị (AEs) nke ndị nyocha na-akọ bụ neutropenia, ụbara aspartate aminotransferase, anaemia, mbelata ọnụ ọgụgụ ọbara ọcha, ịba ụba alanine aminotransferase, ọbara mgbali elu, afọ ntachi na asthenia.