Mushonga Mutsva Wekushandisa Kurapa KweGomarara Risiri Diki Sero Remapapu

CSstone Pharmaceuticals, kambani yebiopharmaceutical yakatarisana nekutsvagisa, kusimudzira, uye kutengeserana kweazvino immuno-oncology therapies nemishonga chaiyo, yakazivisa nhasi kuti mushonga mutsva wekushandisa (NDA) wepralsetinib kurapwa kwekurongedzerwa panguva yekutapurirana (RET) fusion-positive munharaunda. advanced kana metastatic isiri-diki cell yemapapu cancer (NSCLC) yakagamuchirwa muHong Kong, China.

Pralsetinib ine simba uye inosarudza RET inhibitor yakawanikwa nemumwe weCSstone Blueprint Medicines. Cstone ine chibvumirano chakasarudzika uye rezinesi chibvumirano neBlueprint Mishonga yekusimudzira uye kutengeserana kwepralsetinib muGreater China, iyo inosanganisira Mainland China, Hong Kong, Macau neTaiwan.

Dr. Jason Yang, Chief Medical Officer weCSstone, vakati, “Tinofara zvikuru kuti NDA yemumwe mushonga une hunyanzvi, pralsetinib, inogamuchirwa kurapwa kwepamusoro RET fusion-positive NSCLC, mushure mekunge AYVAKIT® (avapritinib) yatenderwa. kuitira kurapwa kweasingarasikike kana metastatic PDGFRA D842V mutant gastrointestinal stromal tumors muHong Kong, China muna Zvita 2021. Muchikamu chepasi rose 1/2 ARROW chidzidzo, pralsetinib yakaratidza mabhenefiti ekiriniki anogara kwenguva refu uye chimiro chekuchengetedza chinotenderwa muvarwere vane RET fusion. -yakanaka munharaunda yepamusoro kana metastatic NSCLC. Tinotarisira kubvumidzwa kwepralsetinib muHong Kong, China kubatsira varwere vakawanda nekukurumidza sezvinobvira. "

Iko kugamuchirwa kweNDA kwepralsetinib muHong Kong, China kwakavakirwa pamibairo kubva muchikamu chepasi rose 1/2 ARROW kudzidza. Muyedzo uyu wakagadzirirwa kuongorora kuchengetedzwa, kushivirira, uye kushanda kwepralsetinib muvarwere vane RET-fusion positive NSCLC, RET-mutant medullary thyroid cancer (MTC), uye mamwe mapundu akasimba akasimba ane RET fusions.

Mhedzisiro kubva muyedzo yeARROW muvarwere vepasi rose vane advanced RET fusion-positive NSCLC yakaunzwa pa2021 American Society of Clinical Oncology (ASCO) Annual Meeting muna Chikumi 2021. Kubva pazuva rekupedzisira remusi waNovember 6, 2020, pralsetinib yakaratidza kugara kwenguva refu kwekiriniki. mabhenefiti muvarwere vane RET fusion-positive NSCLC vaive nechirwere chinoyerwa pakutanga uye vakagamuchira dhigirii rekutanga re400 mg kamwe pazuva.

• Mune 68 kurapwa-naïve varwere, iyo yose yekupindura chiyero (ORR) yaiva 79 muzana (95% CI: 68%, 88%). Mhinduro yakakwana (CR) chiyero chaive 6 muzana, gumi muzana yevarwere vaive nekudzoreredza kwakazara kwemamota anotangwa, uye 10 muzana yevarwere vaive nechikamu chemhinduro (PR). Nguva yepakati yekupindura (DOR) haina kusvika (74% CI: 95 mwedzi, isina kusvika).

• Muvarwere ve126 vakambogamuchira platinum-based chemotherapy, ORR yaiva 62 muzana (95% CI: 53%, 70%). Chiyero cheCR chaive 4 muzana, 12 muzana yevarwere vaive nekudzoserwa kwakazara kwemamota anotangwa, uye 58 muzana yevarwere vaive nePR. Iyo yepakati DOR yaive mwedzi 22.3 (95% CI: 15.1 mwedzi, isina kusvika).

• Nekuda kweiyo data cutoff date, huwandu hwevarwere ve471 vakanyoreswa mumhando dzemamota ne pralsetinib dose kutanga pa400 mg kamwe pazuva. Zviitiko zvinowanzoitika zvehutano zvine chokuita nemishonga (AEs) zvakashumwa nevatsvakurudzi vaiva neutropenia, yakawedzera aspartate aminotransferase, anemia, kuderera kwemasero machena eropa, kuwedzera alanine aminotransferase, hypertension, kuvimbiswa uye asthenia.