Codsiga Cusub ee Dawada ee loogu talagalay daawaynta Kansarka sambabada Unug Yaryar

CStone Pharmaceuticals, oo ah shirkad biopharmaceutical ah oo diiradda saarey cilmi baarista, horumarinta, iyo ganacsiga ee daaweynta cusub ee immuno-oncology iyo daawooyinka saxda ah, ayaa maanta ku dhawaaqay in codsiga cusub ee daawada (NDA) ee pralsetinib ee daaweynta dib-u-habeynta inta lagu jiro gudbinta (RET) isku-dhafka gudaha gudaha Kansarka sambabada unugyada aan yarayn ama metastatic (NSCLC) ayaa laga aqbalay Hong Kong, Shiinaha.

Pralsetinib waa horjooge awood leh oo la xushay RET oo uu helay CSstone lammaanihiisa Dawooyinka Blueprint. CSstone waxay leedahay wada shaqayn gaar ah iyo heshiis shati ah oo ay la leedahay Dawooyinka Blueprint ee horumarinta iyo ganacsiga ee pralsetinib ee Shiinaha Weyn, kaas oo ka kooban Mainland Shiinaha, Hong Kong, Macau iyo Taiwan.

Dr. Jason Yang, Madaxa Caafimaadka ee CSstone, ayaa yiri, "Aad ayaan ugu faraxsanahay in NDA ee dawo kale oo sax ah oo sax ah, pralsetinib, loo aqbalo daaweynta sare ee RET fusion-positive NSCLC, ka dib markii AYVAKIT® (avapritinib) la ansixiyay. loogu talagalay daawaynta aan la sixi karin ama metastatic PDGFRA D842V mutant stromal burooyinka caloosha iyo mindhicirka ee Hong Kong, Shiinaha Diisambar 2021. Marxaladda caalamiga ah ee 1/2 ARROW daraasadda, pralsetinib waxay muujisay faa'iidooyin caafimaad oo waara iyo guud ahaan si wanaagsan loo dulqaatay astaanta badbaadada bukaanada qaba isku-dhafka RET -positive maxalli horumarsan ama NSCLC metastatic. Waxaan rajeyneynaa oggolaanshaha suurtagalka ah ee pralsetinib ee Hong Kong, Shiinaha si ay uga caawiso ka faa'iidaysiga bukaanno badan sida ugu dhakhsaha badan ee suurtogalka ah. "

Aqbalaada NDA ee pralsetinib ee Hong Kong, Shiinaha waxay ku salaysan tahay natiijooyinka wejiga caalamiga ah ee 1/2 ARROW. Tijaabadaan waxaa loogu talagalay in lagu qiimeeyo badbaadada, dulqaadka, iyo waxtarka pralsetinib ee bukaanada qaba RET-fusion positive NSCLC, RET-mutant medullary thyroid cancer (MTC), iyo burooyin kale oo adag oo horumarsan oo leh fiyuusyada RET.

Natiijooyinka tijaabada ARROW ee bukaannada caalamiga ah ee leh NSCLC-da sare ee RET fusion-positive ayaa lagu soo bandhigay 2021 American Society of Clinical Oncology (ASCO) Kulanka Sannadlaha ah ee Juun 2021. Ilaa taariikhda la gooyey ee Noofambar 6, 2020, pralsetinib waxay muujisay bukaan-socod caafimaad oo waara. faa'iidooyinka bukaanada qaba RET fusion-positive NSCLC kuwaas oo lahaa cudur la qiyaasi karo markii la bilaabay oo helay qiyaasta bilawga ah ee 400 mg hal mar maalintii.

• 68 bukaan oo daawaynta-nafive ah, heerka jawaabta guud (ORR) wuxuu ahaa 79 boqolkiiba (95% CI: 68%, 88%). Heerka jawaabta dhamaystiran (CR) wuxuu ahaa 6 boqolkiiba, 10 boqolkiiba bukaanada ayaa si buuxda u soo laabtay burooyinka bartilmaameedka ah, iyo 74 boqolkiiba bukaanada ayaa helay jawaab celin qayb ah (PR). Muddada jawaabta dhexdhexaadka ah (DOR) lama gaarin (95% CI: 9.0 bilood, lama gaarin).

• Bukaannada 126 ee hore u qaatay kiimoterabi ku salaysan platinum, ORR wuxuu ahaa 62 boqolkiiba (95% CI: 53%, 70%). Heerka CR wuxuu ahaa 4 boqolkiiba, 12 boqolkiiba bukaannada ayaa si buuxda u soo noqday burooyinka bartilmaameedka ah, iyo 58 boqolkiiba bukaannada ayaa lahaa PR. Dhexdhexaadka DOR wuxuu ahaa 22.3 bilood (95% CI: 15.1 bilood, lama gaarin).

• Ilaa taariikhda la jaray xogta, wadar 471 bukaan ah ayaa la diiwaan galiyay dhammaan noocyada burooyinka oo leh qiyaas pralsetinib oo ka bilaabmaya 400 mg hal mar maalintii. Dhacdooyinka xunxun ee ugu badan ee la xidhiidha daawaynta (AEs) ee ay soo sheegeen baarayaashu waxay ahaayeen neutropenia, kororka aminotransferase aspartate, dhiig-yaraan, hoos u dhaca tirada unugyada dhiiga cad, korodhka alanine aminotransferase, hypertension, calool-istaag iyo asthenia.