Fabrairu 2023: Enhertu (trastuzumab deruxtecan) daga AstraZeneca da Daiichi Sankyo an yarda da shi azaman monotherapy don kula da tsofaffi marasa lafiya tare da ciwon nono mara kyau ko kuma mai tsanani na HER2 mai kyau wanda ya karbi daya ko fiye kafin tsarin maganin HER2.
Enhertu shine injiniyan injiniya na musamman na HER2-directed antibody drugs conjugate (ADC) wanda AstraZeneca da Daiichi Sankyo suna haɓakawa tare da tallatawa.
In the DESTINY-Breast03 Phase III trial, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1) (hazard ratio [HR] 0.28; 95% confidence interval [CI] 0.22-0.37; p0.000001) in patients with HER2-positive unresectable and/or metastatic ciwon nono previously treated with trastuzumab and a taxan
A kasar Sin, cutar kansar nono ita ce cutar kansa da ta fi kamari a tsakanin mata, inda ake sa ran samun cutar kanjamau sama da 415,000 a shekarar 2020.
Kimanin kashi 1% na mutuwar cutar kansar nono a duniya ya faru ne a China a cikin 18, tare da mutuwar kusan 2020 da ake dangantawa da kansar nono. 120,00 Kusan ɗaya daga cikin biyar na cutar kansar nono yana da HER1 mai kyau. 2
Mista Binghe Xu, MD, Farfesa kuma Darakta na Sashen Likitan Oncology, Asibitin Ciwon daji da Asibitin Ciwon daji, Cibiyar Nazarin Kiwon Lafiya ta kasar Sin, ya bayyana cewa, "Wannan amincewar tana wakiltar wani muhimmin ci gaba ga al'ummar cutar kansar nono a kasar Sin, a matsayin masu fama da cutar HER2- tabbataccen ciwon nono na metastatic yana ci gaba da buƙatar ƙarin zaɓuɓɓukan magani. Duk da jiyya na farko, marasa lafiya tare da HER2-tabbataccen ciwon nono na nono akai-akai suna fuskantar ci gaban cuta, yana nuna mahimmancin kula da cututtukan tsarin farko da yuwuwar Enhertu don taimaka wa marasa lafiya da ciwon nono mai ƙazanta waɗanda suka cancanci magani.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, stated, “This first approval of Enhertu in China represents a significant advancement in the treatment of HER2-targetable tumours and offers patients with previously treated HER2-positive metastatic breast cancer the opportunity to benefit from this important medication as a second line therapy. The approval demonstrates our commitment to patients in China, where the incidence of breast cancer has increased, as we continue to investigate the potential benefits of Enhertu in the treatment of HER2-directed metastatic breast cancer and other HER2-targetable cancers.
Kiminori Nagao, Shugaban Sashin Kasuwancin Daiichi Sankyo na Asiya, Kudancin da Amurka ta Tsakiya (ASCA), ya bayyana cewa, “Enhertu yana tsawaita lokaci kafin ci gaban cuta ko mutuwa kuma yana taimakawa wajen sake fayyace sakamakon ga marasa lafiya da ke fama da cutar sankarar nono mai kyau ta HER2 a baya, kuma yanzu likitoci a kasar Sin za su sami damar samun wannan muhimmin magani ga majinyatan su. Tare da wannan amincewa, Enhertu yana da yuwuwar zama sabon tsarin kulawa a kasar Sin ga marasa lafiya da ke da cutar kansar nono mai cutar HER2 mai kyau a cikin saitin layi na biyu."
In DESTINY-Breast03, Enhertu’s safety profile was looked at in 257 patients with HER2-positive breast cancer that could not be removed or had spread to other parts of the body. It was similar to what had been seen in previous gwaji na asibiti, and no new safety concerns were found. Nausea (75.9%), fatigue (49.4%), vomiting (49.0%), neutropenia (42.8%), and alopecia (37%) were the most common adverse reactions.
Wannan amincewar ta biyo bayan Zayyana Nazari na Farfadowar Farko na NMPA na kasar Sin da nazartar fifiko na Enhertu don irin wannan nau'in kansar nono a shekarar 2022.
Notes
Ciwon daji na nono da bayyanar HER2
Cutar sankarar nono ita ce cutar sankara mafi yawa kuma daya daga cikin manyan abubuwan da ke haifar da mace-mace masu alaka da cutar kansa a duniya.3 Fiye da marasa lafiya miliyan biyu ne aka gano suna da cutar kansar nono a cikin 2020, tare da mutuwar kusan 685,000 a duniya.3 A kasar China, cutar kansar nono ita ce cutar kansa da aka fi sani da mata, inda a shekarar 415,000 aka samu sama da majiyyata 2020.1 An sami mutuwar cutar kansar nono kusan 120,000 a China a cikin 2020, wanda ke wakiltar kusan kashi 18% na mutuwar cutar kansar nono a duniya.1 Kusan ɗaya cikin biyar na ciwon nono ana ɗaukar HER2-tabbatacce.2
HER2 shine tyrosine kinase receptor girma-promoting furotin da aka bayyana a saman nau'ikan ciwace-ciwacen daji da suka hada da nono, ciki, huhu, da ciwon daji. da rashin hangen nesa a cikin ciwon nono.5
Duk da jiyya na farko tare da trastuzumab da haraji, marasa lafiya tare da HER2-tabbataccen ciwon nono na nono sau da yawa za su fuskanci ci gaban cuta.6,7
KADDARA-NONO03
DESTINY-Breast03 na duniya ne, kai-da-kai, bazuwar, buɗaɗɗen lakabin, gwaji na Mataki na III na rijista yana kimanta inganci da amincin Enhertu (5.4mg/kg) tare da T-DM1 a cikin marasa lafiya tare da HER2-tabbatacce wanda ba a iya gyarawa da / ko ciwon nono na metastatic wanda aka bi da shi tare da trastuzumab da haraji.
Babban mahimmin inganci na DESTINY-Breast03 shine tsira mara-ci gaba (PFS) dangane da makantar tsakiyar bita (BICR). Gabaɗaya rayuwa (OS) shine ma'aunin ingantaccen sakamako na biyu. Sauran wuraren ƙarshen inganci na biyu sun haɗa da ƙimar amsa haƙiƙa (ORR), tsawon lokacin amsawa, PFS dangane da ƙimar mai bincike da aminci. Sakamako na farko daga DESTINY-Breast03 an buga a The New England Journal of Medicine,8 tare da sabunta PFS da sakamakon OS da aka buga a The Lancet.9
DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia, Europe, North America, Oceania and South America.
Enhertu
Enhertu ADC ne na HER2. An ƙera shi ta amfani da fasahar DXd ADC na Daiichi Sankyo, Enhertu shine jagorar ADC a cikin fayil ɗin oncology na Daiichi Sankyo kuma mafi girman shirin a dandalin ADC na AstraZeneca. Enhertu ya ƙunshi HER2 monoclonal antibody da ke haɗe zuwa topoisomerase I inhibitor payload, wani abin da aka samu na exatecan, ta hanyar hanyar haɗin gwiwa ta tsayayyen tetrapeptide.er.
Enhertu (5.4mg/kg) an yarda da shi a cikin ƙasashe fiye da 40 don kula da marasa lafiya marasa lafiya tare da ciwon nono wanda ba a san shi ba ko metastatic HER2-tabbataccen ciwon nono wanda ya karbi (ko ɗaya ko fiye) kafin tsarin HER2 na gaba, ko dai a cikin metastatic. saitin ko a cikin neoadjuvant ko adjuvant saitin, kuma sun ci gaba da sake dawowa da cututtuka a cikin ko a cikin watanni shida na kammala jiyya bisa sakamakon gwajin DESTINY-Breast03.
Enhertu (5.4mg/kg) an yarda da shi a cikin ƙasashe fiye da 30 don kula da marasa lafiya marasa lafiya tare da HER2-low maras dacewa (immunohistochemistry [IHC] 1+ ko IHC 2+ / in-situ hybridization [ISH] -) ciwon nono wanda sun karɓi maganin tsarin da aka rigaya a cikin yanayin haɓaka ko haɓaka sake dawowar cuta a cikin ko a cikin watanni shida na kammala chemotherapy na adjuvant dangane da sakamakon gwajin KADDARA-Breast04.
Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic cututtukan daji na kansa marasa kansar whose tumours have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma waɗanda suka karɓi tsarin tushen trastuzumab na baya dangane da sakamakon gwajin DESTINY-Gastric01 da/ko gwajin DESTINY-Gastric02.
Enhertu shirin ci gaba
Ana gudanar da cikakken shirin ci gaban duniya yana kimanta inganci da amincin Enhertu monotherapy across multiple HER2-targetable cancers including breast, gastric, lung and ciwan kansa. Trials in combination with other anticancer treatments, such as immunotherapy, kuma ana kan tafiya.
Haɗin gwiwar Daiichi Sankyo
Kamfanin Daiichi Sankyo, Limited (TSE: 4568) [wanda ake kira Daiichi Sankyo] da AstraZeneca sun shiga haɗin gwiwar duniya don haɓakawa da kasuwanci tare. Enhertu (ADC mai jagorancin HER2) a cikin Maris 2019, da datopotamab deruxtecan (DS-1062; ADC mai jagorar TROP2) a cikin Yuli 2020, sai dai a cikin Japan inda Daiichi Sankyo ke kiyaye haƙƙin keɓancewar. Daiichi Sankyo ne ke da alhakin masana'antu da samar da kayayyaki Enhertu datopotamab deruxtecan.
AstraZeneca a cikin ciwon nono
Ƙarfafa fahimtar ilimin ilmin halitta na ciwon nono, AstraZeneca ya fara ƙalubalanci, da kuma sake fasalin, yanayin halin yanzu na asibiti don yadda ake rarraba ciwon nono da kuma bi da shi don isar da magunguna masu mahimmanci ga marasa lafiya da suke bukata - tare da m kishi don kawar da wata rana. ciwon nono a matsayin sanadin mutuwa.
AstraZeneca yana da cikakkiyar fayil na abubuwan da aka yarda da su kuma masu ban sha'awa a cikin haɓakawa waɗanda ke ba da damar hanyoyin aiki daban-daban don magance yanayin ƙwayar cutar kansar nono daban-daban.
tare da Enhertu (trastuzumab deruxtecan), HER2-directed ADC, AstraZeneca da Daiichi Sankyo suna nufin haɓaka sakamako a cikin HER2-tabbatacce da HER2-low metastatic ciwon nono kuma suna binciken yuwuwar sa a cikin layin farko na jiyya kuma a cikin sabbin saitunan ciwon nono.
A cikin ciwon nono mai kyau na HR, AstraZeneca ya ci gaba da inganta sakamako tare da magunguna na tushe Faslodex (cikakke) kuma Zoladex (goserelin) kuma yana nufin sake fasalin sararin HR-tabbatacce tare da SERD na gaba-gaba da yuwuwar sabbin magungunan camizestrant, da kuma mai hanawa AKT kinase na farko, capivasertib. AstraZeneca kuma yana haɗin gwiwa tare da Daiichi Sankyo don bincika yuwuwar TROP2-directed ADC, datopotamab deruxtecan, a cikin wannan saitin.
Mai hana PARP Lynparza (olaparib) zaɓin magani ne da aka yi niyya wanda aka yi nazari a farkon da kuma masu cutar kansar nono da aka gada tare da maye gurbin BRCA. AstraZeneca da MSD (Merck & Co., Inc. a Amurka da Kanada) suna ci gaba da bincike Lynparza a cikin waɗannan saitunan da kuma bincika yiwuwarsa a cikin cututtuka na baya.
Don kawo zaɓuɓɓukan magani da ake buƙata da yawa ga marasa lafiya da ciwon nono mara kyau sau uku, wani nau'in cutar kansar nono, AstraZeneca yana kimanta yuwuwar datopotamab deruxtecan kadai kuma a hade tare da immunotherapy Imfinzi (durvalumab), capivasertib a hade tare da chemotherapy, da Imfinzi a hade tare da wasu magungunan oncology, ciki har da Lynparza da kuma Enhertu.
AstraZeneca a cikin Oncology
AstraZeneca tana jagorantar juyin juya hali a cikin ilimin cututtukan daji tare da burin samar da magunguna don ciwon daji ta kowane nau'i, bin kimiyya don fahimtar ciwon daji da duk hadaddun sa don ganowa, haɓakawa, da isar da magunguna masu canza rayuwa ga marasa lafiya.
Kamfanin ya mayar da hankali kan wasu daga cikin mafi ƙalubalanci ciwon daji. Ta hanyar ci gaba da bidi'a ne AstraZeneca ya gina ɗayan manyan fayiloli da bututun mai a cikin masana'antar, tare da yuwuwar haɓaka canje-canje a cikin aikin likitanci da canza ƙwarewar haƙuri.
AstraZeneca yana da hangen nesa don sake fasalin kula da ciwon daji kuma, wata rana, kawar da ciwon daji a matsayin dalilin mutuwa.
AstraZeneca
AstraZeneca (LSE / STO / Nasdaq: AZN) wani kamfani ne na duniya, wanda ke jagorantar kimiyyar biopharmaceutical wanda ke mayar da hankali kan ganowa, haɓakawa, da kuma sayar da magungunan magani a Oncology, Rare Diseases, da BioPharmaceuticals, ciki har da Cardiovascular, Renal & Metabolism, da Respiratory. & Immunology. An kafa shi a cikin Cambridge, UK, AstraZeneca yana aiki a cikin ƙasashe sama da 100, kuma miliyoyin marasa lafiya suna amfani da sabbin magungunan sa.
References
1. Wei Cao, et al. Canza bayanan martaba na nauyin kansa a duk duniya da kuma a China: nazari na biyu na kididdigar cutar kansa ta duniya 2020. Chin Med J (Engl). 2021 Afrilu 5; 134 (7): 783-791.
2. Ahn S, et al. Matsayin HER2 a cikin ciwon nono: canje-canje a cikin jagororin da abubuwa masu rikitarwa don fassarar. J Pathol Transl Med. 2020; 54(1): 34-44.
3. Sung H, da dai sauransu. Kididdigar Ciwon daji na Duniya 2020: GLOBOCAN Ƙididdiga na Haɗuwa da Mutuwar Duniya a Duniya don Ciwon daji guda 36 a cikin ƙasashe 185. CA Cancer J Clin. 2021; 10.3322/caac.21660.
4. Iqbal N, et al. Mai karɓa na Girman Ci gaban ɗan Adam na Epidermal 2 (HER2) a cikin Ciwon daji: Ƙarfafawa da Mahimman Ciwon Magunguna. Mol Biol Int. 2014; 852748.
5. Pillai R, et al. HER2 mutations in lung adenocarcinomas: A report from the huhu Cancer Mutation Consortium. Cancer. 2017;1;123(21):4099-4105.
6. Barok M, et al. Trastuzumab emtansine: tsarin aiki da juriya na miyagun ƙwayoyi. Ciwon Kankara Res. 2014; 16 (2): 209.
7. Nader-Marta G, et al. Yadda muke bi da marasa lafiya da ke da cutar kansar nono mai tabbatacciyar HER2. Buɗe ESMO. 2022; 7:1 .
8. Cortes J, et al. Trastuzumab Deruxtecan da Trastuzumab Emtansine don Ciwon Nono. N Engl J Med. 2022; 386: 1143-1154.
9. Hurvitz S, et al. Trastuzumab deruxtecan tare da trastuzumab emtansine a cikin marasa lafiya tare da HER2-tabbatacce metastatic ciwon nono: sakamakon da aka sabunta daga DESTINY-Breast03, bazuwar, lakabin buɗewa, gwaji na 3. Lancet. 2022 Dec 6;S0140-6736(22)02420-5.
