Kopo e Ncha ea Lithethefatsi bakeng sa Kalafo ea Kankere e Seng e Nyenyane ea Matšoafo ea Cell

CSstone Pharmaceuticals, k'hamphani ea biopharmaceutical e tsepamisitseng maikutlo ho lipatlisiso, nts'etsopele, le khoebo ea mekhoa e mecha ea phekolo ea immuno-oncology le meriana e nepahetseng, e phatlalalitse kajeno hore ts'ebeliso e ncha ea lithethefatsi (NDA) bakeng sa pralsetinib bakeng sa phekolo ea ho hlophisoa bocha nakong ea phetiso (RET) fusion-positive sebakeng sa heno. Kankere e tsoetseng pele kapa ea metastatic e seng e nyane ea lisele tsa matšoafo (NSCLC) e amohetsoe Hong Kong, China.

Pralsetinib ke RET inhibitor e matla le e khethang e fumanoeng ke molekane oa Cstone Blueprint Medicines. Cstone e na le tumellano e khethehileng ea tšebelisano-'moho le laesense le Blueprint Medicines bakeng sa nts'etsopele le khoebo ea pralsetinib naheng ea Greater China, e kenyeletsang Mainland China, Hong Kong, Macau le Taiwan.

Dr. Jason Yang, Ofisiri e ka Sehloohong ea Bongaka ea Cstone, o itse, "Re thabile haholo hore ebe NDA ea meriana e 'ngoe e ncha e nepahetseng, pralsetinib, e amoheloa bakeng sa phekolo ea NSCLC e tsoetseng pele ea RET fusion-positive, ka mor'a hore AYVAKIT® (avapritinib) e amoheloe. bakeng sa kalafo ea PDGFRA D842V e sa tsitsang kapa ea metastatic tumors ho Hong Kong, China ka December 2021. Thutong ea lefats'e ea 1/2 ARROW, pralsetinib e bonts'itse melemo ea nako e telele ea kliniki le boemo bo lumelletsoeng ka kakaretso ba polokeho ho bakuli ba fusion ea RET. -e ntle sebakeng sa heno e tsoetseng pele kapa e metastatic NSCLC. Re lebelletse tumello e ka bang teng ea pralsetinib Hong Kong, China ho thusa bakuli ba bangata kapele kamoo ho ka khonehang. ”

Kamohelo ea NDA ea pralsetinib Hong Kong, Chaena e ipapisitse le liphetho tsa thuto ea lefats'e ea 1/2 ARROW. Teko ena e etselitsoe ho lekola polokeho, mamello, le katleho ea pralsetinib ho bakuli ba nang le RET-fusion positive NSCLC, RET-mutant medullary thyroid cancer (MTC), le lihlahala tse ling tse tsoetseng pele tse tiileng tse nang le RET fusions.

Liphetho ho tsoa tekong ea ARROW ho bakuli ba lefats'e ba nang le NSCLC e tsoetseng pele ea RET fusion-positive li hlahisitsoe Kopanong ea Selemo ea 2021 American Society of Clinical Oncology (ASCO) ka Phuptjane 2021. melemo ho bakuli ba nang le RET fusion-positive NSCLC ba neng ba e-na le lefu le lekanyang qalong 'me ba fuoa tekanyo ea ho qala ea 6 mg hang ka letsatsi.

• Ho bakuli ba 68 ba hlokang phekolo, tekanyo ea kakaretso ea karabo (ORR) e ne e le karolo ea 79 lekholong (95% CI: 68%, 88%). Karabelo e felletseng (CR) e ne e le liperesente tse 6, liperesente tse 10 tsa bakuli ba ne ba e-na le khatello e felletseng ea lihlahala tse lebisitsoeng, mme karolo ea 74 lekholong ea bakuli e ne e e-na le karabelo e sa fellang (PR). Nako e bohareng ea karabo (DOR) ha ea ka ea finyelloa (95% CI: likhoeli tsa 9.0, ha e fihleloe).

• Ho bakuli ba 126 ba kileng ba fumana chemotherapy e thehiloeng platinum, ORR e ne e le karolo ea 62 lekholong (95% CI: 53%, 70%). Sekhahla sa CR e ne e le karolo ea 4 lekholong, karolo ea 12 lekholong ea bakuli ba ne ba e-na le ho fokotseha ho feletseng ha lihlahala tse lebisitsoeng, 'me karolo ea 58 lekholong ea bakuli ba ne ba e-na le PR. DOR e bohareng e ne e le likhoeli tsa 22.3 (95% CI: likhoeli tsa 15.1, ha e fihlelle).

• Ho tloha letsatsing la ho khaola ha data, kakaretso ea bakuli ba 471 ba ngolisitsoe ho mefuta eohle ea tumor ka tekanyo ea pralsetinib e qalang ho 400 mg hang ka letsatsi. Liketsahalo tse mpe ka ho fetisisa tse amanang le phekolo (AEs) tse tlalehiloeng ke bafuputsi e ne e le neutropenia, ho eketseha ha aspartate aminotransferase, phokolo ea mali, ho fokotseha ha lisele tse tšoeu tsa mali, ho eketseha ha alanine aminotransferase, khatello ea mali, ho pata le asthenia.