Apono 'ia ka Ha'awina Lapa'au Lapa'au Hou

Ua hoʻolaha ʻo Shanghai Henlius Biotech, Inc. ua hoʻokō ka loiloi interim mua i ka hopena o ka noiʻi mua o ke ola holoʻokoʻa (OS) o ka Phase 3 clinical study (NCT04063163) o kāna mea hou PD-1 inhibitor serplulimab i hui pū ʻia me ka chemotherapy i nā poʻe maʻi i mālama ʻole ʻia. ka ma'i 'a'ai ma'i 'a'ai li'ili'i li'ili'i (ES-SCLC). ʻAʻohe anti-PD-1 mAb i ʻāpono ʻia no ka mālama ʻana i ka maʻi maʻi ʻaʻai liʻiliʻi liʻiliʻi liʻiliʻi (ES-SCLC) ma ka honua holoʻokoʻa.

ʻO ke kumu nui o ka haʻawina ʻo ka ʻimi ʻana i ka pono a me ka palekana o ka serplulimab i hui pū ʻia me ka chemotherapy i nā maʻi maʻi i mālama ʻole ʻia me ES-SCLC. Ma muli o nā hopena o kahi loiloi interim i wehewehe mua ʻia e ka Independent Data Monitoring Committee (IDMC), ʻo serplulimab i hui pū ʻia me ka chemotherapy i hōʻike i kahi hoʻomaikaʻi koʻikoʻi i ka OS e kūʻē i ka chemotherapy, ka mea i hoʻokō i nā pae hoʻohālike i hoʻoholo mua ʻia, me ka palekana maikaʻi a ʻaʻole. ʻike i kahi hōʻailona palekana hou. Ua manaʻo ʻo IDMC e hiki i ka hui ke kamaʻilio me ka mana olakino.

He ʻino loa ka SCLC, a ua kaupalena ʻia ka lāʻau lapaʻau i loaʻa

Wahi a ka ʻikepili GLOBOCAN, ʻo ka maʻi ʻaʻai māmā (LC) ka lua o ka maʻi maʻi maʻi maʻamau a puni ka honua a ʻo ia ka 11.4% o ka maʻi maʻi maʻi honua i 2020. Ua manaʻo ʻia aia he 810,000 mau hihia hou me LC ma Kina i 2020, a ʻo LC ka kumu nui o ka ma'i 'a'ai a me ka make. ʻO SCLC ka helu no 15% -20% ma waena o LC, a ʻo ia ka subtype koʻikoʻi loa o LC, i māhele ʻia i loko o ka palena liʻiliʻi liʻiliʻi maʻi maʻi maʻi maʻi maʻi (LS-SCLC) a me ES-SCLC. ʻO ka hapa nui o nā maʻi aia i ka pae nui ke ʻike ʻia. ʻO ka poʻe maʻi me ES-SCLC mau ka ulu wikiwiki a me ka wānana maikaʻi ʻole. ʻOi aku ka pōkole o ke ola ʻana o kekahi ma muli o ka nui o ka metastasis tumor a me ke kūlana kino kino wale nō me ka mālama kākoʻo.

Ma luna o 20 makahiki, etoposide a me carboplatin / cisplatin ka mea maʻamau o ka mālama 'ana no ka ES-SCLC, akā, 80% o nā mea maʻi me ka palena o ka maʻi maʻi a kokoke i nā mea maʻi a pau me ka nui pae maʻi relapse i loko o hoʻokahi makahiki, me ka median ola o ka 4 wale nō a hiki. 5 mahina ma hope o ka hoʻihoʻi ʻana. ʻO ka puka ʻana mai o nā mea hoʻopaʻa hoʻopaʻapaʻa immune e hāʻawi i kahi koho hou. I kēia manawa, ua ʻōlelo ʻia ka anti-PD-L1 mAb i hui pū ʻia me ka chemotherapy e nā alakaʻi NCCN hou a me nā alakaʻi CSCO ma ke ʻano he lāʻau lapaʻau mua no ES-SCLC. Eia nō naʻe, ke kū nei ka hoʻohana ʻana i ka immunotherapy ma ES-SCLC i nā pilikia. I nā makahiki i hala iho nei, ua hāʻule kekahi mau PD-1 mAbs ma ia wahi. No laila, ʻoi aku ka maikaʻi o ka lāʻau lapaʻau mua o ka PD-1 inhibitors e koi koke ʻia.

Ke kau nei i ka pono ʻole o ka poʻe maʻi, e uhi ana i ka lāʻau lapaʻau mua o nā ʻano āpau o ka maʻi kanesa āpau

Ua lawe ʻo Henlius i kahi hoʻolālā ʻokoʻa "Combo+Global" ma serplulimab. I kēia manawa, ua ʻae ʻia ka serplulimab no nā hoʻokolohua lapaʻau ma Kina, ʻAmelika Hui Pū ʻIa, ʻEulopa a me nā ʻāina a me nā ʻāina ʻē aʻe. He 10 immuo-oncology therapies nā ho'āʻo hoʻokolohua lapaʻau o serplulimab e loiloi i kona palekana a me ka maikaʻi i nā ʻano maʻi ʻokoʻa paʻa e uhi ana i ka LC, hepatocellular carcinoma, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer etc. ʻO ka lā, ma kahi o 2300 mau maʻi i kākau inoa ʻia ma ka honua holoʻokoʻa, e hōʻike ana i ka maikaʻi o ka serplulimab i kūkulu i ka hilinaʻi i nā mākeke haole. I ʻApelila, ua ʻae ʻia ka New Drug Application (NDA) o serplulimab no ka mālama ʻana i nā ʻōpū paʻa MSI-H e ka National Medical Products Administration (NMPA) a hāʻawi ʻia i ka loiloi mua, i manaʻo ʻia e ʻae ʻia i ka hapa mua o 2022.

Wahi a nā hiʻohiʻona o nā mea maʻi maʻi maʻi ma ka honua a ma Kina, ua nānā ka ʻoihana i ka maʻi kanesa a me ka maʻi maʻi ʻōpū me ka serplulimab ma ke kua. Ua hoʻokō ʻo Henlius i kahi hoʻolālā lāʻau lapaʻau mua o LC, a ua hoʻokō ʻo ia i nā hoʻokolohua ma serplulimab ma sqNSCLC, non-squamous non-liʻiliʻi pūkuniahi maʻi maʻi a me SCLC, e uhi ana ma mua o 90% o nā maʻi maʻi maʻi maʻi. Ma muli o ka ho'āʻo hoʻokolohua hoʻokolohua hoʻokolohua hoʻāʻo ʻo Phase 3 ma waena o nā mea maʻi i mālama ʻole ʻia me ka sqNSCLC kūlana kiʻekiʻe a i ʻole metastatic, ʻo ka NDA o serplulimab no ka lāʻau lapaʻau mua o ka sqNSCLC kūloko a i ʻole metastatic sqNSCLC ua ʻae ʻia e ka NMPA . I ka wā e hiki mai ana, me ka nui o ka ʻikepili noiʻi lapaʻau honua, e hoʻomau ʻo Henlius i ka hoʻonui ʻana i ka hoʻolaha honua o serplulimab a e hoʻopōmaikaʻi i nā mea maʻi a puni ka honua.