Shanghai Henlius Biotech, Inc. yakazivisa kuti ongororo yekutanga yenguva pfupi yakasangana nemhedzisiro yekudzidza kwese kwese (OS) yePhase 3 yekiriniki yekudzidza (NCT04063163) yekuvandudza kwayo PD-1 inhibitor serplulimab pamwe nekemotherapy muvarwere vasina kurapwa kare. yakakura-danho diki kenza yemapapu (ES-SCLC). Iko hakuna anti-PD-1 mAb yakabvumidzwa kurapwa kweakakura-nhanho diki kenza yemapapu (ES-SCLC) pasi rese.
Chinangwa chikuru chechidzidzo ichi ndechekuongorora kushanda uye kuchengetedzeka kweserplulimab pamwe chete nechemotherapy muvarwere vaimbove vasina kurapwa neES-SCLC. Zvichienderana nemhedzisiro yeongororo yakatsanangurwa yenguva pfupi yakaitwa neiyo Independent Data Monitoring Committee (IDMC), serplulimab pamwe chete nechemotherapy yakaratidza kuvandudzwa kwakanyanya muOS kurwisa chemotherapy, iyo yakasangana neyakatsanangurwa maitiro ekushanda, nekuchengetedzwa kwakanaka uye pasina. kuonekwa kwechiratidzo chitsva chekuchengetedza. IDMC yakaratidza kuti kambani inogona kutaurirana nechiremera chine hutano.
SCLC ine hutsinye hwakanyanya, uye marapirwo aripo ane mashoma
Zvinoenderana nedata reGLOBOCAN, gomarara remapapu (LC) ikenza yechipiri inowanzo batwa negomarara pasi rose uye inoverengera 11.4% yezviitiko zvegomarara repasi rose muna 2020. Zvinofungidzirwa kuti kune mazana masere nemakumi masere ezviuru zviitiko neLC muChina muna 810,000, uye LC ndiyo chikonzero chikuru chekuitika kwegomarara uye kufa. SCLC inoverengera 2020% -15% pakati peLC, uye ndiyo yakanyanya hutsinye subtype yeLC, iyo yakakamurwa kuita nhanho diki kenza yemapapu (LS-SCLC) uye ES-SCLC. Varwere vazhinji vatova mudanho rakakura kana vaongororwa. Varwere vane ES-SCLC vanogara vaine kukurumidza bundu kukura uye kutadza kufungidzira. Vamwe vavo vane hupenyu hupfupi nekuda kwekuwanda kwebundu metastasis uye kushata kwechimiro chemuviri chete nerutsigiro rwerutsigiro.
Kwemakore makumi maviri, etoposide plus carboplatin/cisplatin ichiri chiyero chekutarisira ES-SCLC, asi 20% yevarwere vane chirwere chetanho shoma uye vangangoita vese varwere vane chirwere chetanho chakakura vanodzoka zvakare mukati megore rimwe, nekupona kwepakati kwe80 chete kusvika. 4 mwedzi mushure mekudzoka zvakare. Kubuda kwe immune checkpoint inhibitors kunopa sarudzo nyowani. Parizvino, anti-PD-L5 mAb yakasanganiswa nechemotherapy yakakurudzirwa neazvino NCCN nhungamiro uye CSCO nhungamiro semutsetse wekutanga kurapwa kweES-SCLC. Nekudaro, iko kushandiswa kwe immunotherapy muES-SCLC kuchiri kutarisana nematambudziko. Mumakore achangopfuura, akati wandei ePD-1 mAbs akakundikana munzvimbo iyi. Naizvozvo, kurapa kwakanyanya kwekutanga kwePD-1 inhibitors kunodiwa nekukurumidza.
Kutarisa pane zvisina kufanira zvinodiwa nevarwere, kuvhara kurapwa kwekutanga kwemhando dzese dzekenza yemapapu
Henlius atora yakasiyaniswa "Combo+Global" zano pane serplulimab. Parizvino, serplulimab yakabvumidzwa kuti iedze kiriniki muChina, United States, European Union nedzimwe nyika nematunhu. Zvose zve 10 immuo-oncology therapies kliniki miedzo ye serplulimab iri kuenderera mberi kuongorora kuchengetedzwa kwayo uye kushanda kwayo mumhando dzakasiyana-siyana dzemamota akasimba anovhara LC, hepatocellular carcinoma, esophageal carcinoma, musoro nemutsipa squamous cell carcinoma uye gomarara remudumbu etc. zuva, vanenge 2300 varwere vakanyoreswa pasi rose, zvichiratidza kuti mhando ye serplulimab yakavaka kuvimba mumisika yekunze. Muna Kubvumbi, iyo New Drug Application (NDA) ye serplulimab yekurapa MSI-H yakasimba tumors yakagamuchirwa neNational Medical Products Administration (NMPA) uye yakapihwa ongororo yekutanga, iyo inotarisirwa kubvumidzwa muhafu yekutanga ya2022.
Zvinoenderana nehunhu hwevarwere vegomarara pasirese uye kuChina, kambani inotarisa pagomarara remapapu negomarara remudumbu ine serplulimab semusana. Henlius akawana yakakwana yekutanga-mutsara wekiriniki marongero eLC, uye akaita miedzo pa serplulimab mu sqNSCLC, isiri-squamous isiri diki cell cancer cancer uye SCLC, inovhara anopfuura makumi mapfumbamwe muzana evarwere vekenza yemapapu. Zvichienderana neasina kurongwa, mapofu maviri, epasirese akawanda-pakati Phase 90 makiriniki ekuedzwa akaitwa muvarwere vasati varapwa vane munharaunda yepamusoro kana metastatic sqNSCLC, iyo NDA ye serplulimab yekurapwa kwemutsara wekutanga kwenzvimbo yepamusoro kana metastatic sqNSCLC yakagamuchirwa neNMPA. . Mune ramangwana, iine data rakawanda rekutsvagisa kwekiriniki yepasirese, Henlius acharamba achiwedzera kugoverwa kwepasi rose kwe serplulimab uye kubatsira varwere vazhinji pasi rese.
ZVOKUBVA MUNYAYA INO:
- Based on the results of a pre-defined interim analysis conducted by the Independent Data Monitoring Committee (IDMC), serplulimab in combination with chemotherapy showed a significant improvement in OS against chemotherapy, which met the pre-defined efficacy criteria, with good safety and no detection of a new safety signal.
- announced that the first interim analysis met the primary study endpoint of the overall survival (OS) of the Phase 3 clinical study (NCT04063163) of its innovative PD-1 inhibitor serplulimab in combination with chemotherapy in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC).
- In April, the New Drug Application (NDA) of serplulimab for the treatment of MSI-H solid tumours was accepted by the National Medical Products Administration (NMPA) and granted priority review, which is expected to be approved in the first half of 2022.
