I-Shanghai Henlius Biotech, Inc. imemezele ukuthi ukuhlaziya kokuqala kwesikhashana kuhlangabezane nesiphetho sokuqala socwaningo lokusinda (OS) seSigaba 3 socwaningo lomtholampilo (NCT04063163) lwe-PD-1 inhibitor serplulimab yayo emisha ehlanganiswe nokwelashwa ngamakhemikhali ezigulini ezazingazange zilashwe ngaphambilini umdlavuza wamaphaphu omncane we-extensive-stage small cell (ES-SCLC). Ayikho i-anti-PD-1 mAb egunyazwe ukwelashwa komdlavuza wamaphaphu wamangqamuzana amancane wesigaba esibanzi (ES-SCLC) emhlabeni jikelele.
Inhloso eyinhloko yocwaningo ukuhlola ukusebenza kahle nokuphepha kwe-serplulimab kuhlanganiswe nokwelashwa ngamakhemikhali ezigulini ezazingazange zilashwe ngaphambilini nge-ES-SCLC. Ngokusekelwe emiphumeleni yokuhlaziywa kwesikhashana okuchazwe ngaphambilini okwenziwa I-Independent Data Monitoring Committee (IDMC), i-serplulimab ihlanganiswe nokwelapha ngamakhemikhali ibonise ukuthuthuka okuphawulekayo ku-OS ngokumelene nokwelashwa ngamakhemikhali, okuhlangabezana nemibandela yokusebenza echazwe ngaphambilini, ngokuphepha okuhle futhi kungekho. ukutholwa kwesignali entsha yokuphepha. I-IDMC yaphakamisa ukuthi inkampani ingaxhumana neziphathimandla ezinempilo.
I-SCLC iyingozi kakhulu, futhi ukwelashwa okutholakalayo kunomkhawulo
Ngokwemininingwane ye-GLOBOCAN, umdlavuza wamaphaphu (LC) ungowesibili umdlavuza ovame ukutholakala emhlabeni jikelele futhi uhlanganisa u-11.4% wezigameko zomdlavuza emhlabeni wonke ngo-2020. imbangela ehamba phambili yezigameko zomdlavuza kanye nokufa. I-SCLC yenza u-810,000% -2020% phakathi kwe-LC, futhi iwuhlobo oluncane olunolaka kakhulu lwe-LC, oluhlukaniswe ngesigaba esilinganiselwe umdlavuza wamaphaphu omncane wengqamuzana (LS-SCLC) kanye ne-ES-SCLC. Iziguli eziningi sezivele zisesigabeni esikhulu lapho zixilongwa. Iziguli ezine-ES-SCLC zihlala zikhula ngokushesha isimila kanye nokubikezela okubi. Abanye babo baphila isikhathi esifushane ngenxa ye-tumor metastasis eningi kanye nesimo esibi somzimba kuphela ngokunakekelwa okusekelayo.
Eminyakeni engaphezu kwengu-20, i-etoposide plus carboplatin/cisplatin iseyindinganiso yokunakekelwa kwe-ES-SCLC, kodwa u-80% weziguli ezinesifo esilinganiselwe futhi cishe zonke iziguli ezinesifo esibi kakhulu ziyaphinda ziphinde zibe phakathi nonyaka owodwa, nokusinda okuphakathi kwabangu-4 kuphela Izinyanga ezi-5 ngemuva kokuphinda. Ukuvela kwe-immune checkpoint inhibitors kunikeza inketho entsha. Njengamanje, i-anti-PD-L1 mAb ehlanganiswe ne-chemotherapy iye yanconywa yiziqondiso zakamuva ze-NCCN kanye nemihlahlandlela ye-CSCO njengokwelashwa komugqa wokuqala kwe-ES-SCLC. Kodwa-ke, ukusetshenziswa kwe-immunotherapy ku-ES-SCLC kusabhekene nezinselelo. Eminyakeni yakamuva, inqwaba ye-PD-1 mAbs yehlulekile endaweni. Ngakho-ke, ukwelashwa okuphumelelayo komugqa wokuqala we-PD-1 inhibitors kuyadingeka ngokushesha.
Igxile ezidingweni ezingafezeki zeziguli, okubandakanya ukwelashwa komugqa wokuqala wazo zonke izinhlobo zomdlavuza wamaphaphu
U-Henlius wamukele isu elihlukile elithi "Combo+Global" ku-serplulimab. Njengamanje, i-serplulimab igunyazelwe izivivinyo zomtholampilo e-China, e-United States, e-European Union nakwamanye amazwe nezifunda. Isamba semithi yokwelapha ye-immuo-oncology eyi-10 izivivinyo zomtholampilo ze-serplulimab ziyaqhubeka ukuhlola ukuphepha nokusebenza kwayo ezinhlobonhlobo zamathumba aqinile ahlanganisa i-LC, i-hepatocellular carcinoma, i-esophageal carcinoma, i-head and neck squamous cell carcinoma kanye nomdlavuza wesisu njll. Usuku, cishe iziguli ezingama-2300 zibhaliswe emhlabeni wonke, okufakazela ukuthi ikhwalithi ye-serplulimab yakhe ukuthembela ezimakethe zangaphandle. Ngo-Ephreli, Isicelo Esisha Sezidakamizwa (i-NDA) se-serplulimab sokwelashwa kwamathumba aqinile we-MSI-H samukelwa yi-National Medical Products Administration (NMPA) futhi sanikezwa ukubuyekezwa okubalulekile, okulindeleke ukuthi kugunyazwe engxenyeni yokuqala ka-2022.
Ngokwezimpawu zeziguli ezinomdlavuza emhlabeni jikelele naseChina, inkampani igxile kumdlavuza wamaphaphu kanye nomdlavuza wesisu ne-serplulimab njengomgogodla. U-Henlius uzuze uhlaka oluphelele lomtholampilo wokuqala we-LC, futhi wenze izivivinyo ku-serplulimab ku-sqNSCLC, umdlavuza wamaphaphu ongasiwo omncane we-squamous kanye ne-SCLC, ehlanganisa ngaphezu kwama-90% eziguli ezinomdlavuza wamaphaphu. Ngokusekelwe kuhlolo lwemitholampilo lweSigaba 3 olungahleliwe, oluyizimpumputhe kabili, lwamazwe ngamazwe olugxile ezindaweni eziningi olwenziwa ezigulini ezazingazange zilashwe ngaphambili ezine-sqNSCLC ethuthukisiwe noma ene-metastatic, i-NDA ye-serplulimab yokwelashwa komugqa wokuqala we-sqNSCLC ethuthukisiwe yendawo noma ene-metastatic yamukelwe yi-NMPA. . Ngokuzayo, ngedatha eningi yocwaningo lwezokwelapha lwamazwe ngamazwe, u-Henlius uzoqhubeka nokwandisa ukusatshalaliswa kwamazwe ngamazwe kwe-serplulimab futhi azuzise iziguli eziningi emhlabeni jikelele.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- 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.
