Febraayo 2023: Enhertu (trastuzumab deruxtecan) oo ka socda AstraZeneca iyo Daiichi Sankyo ayaa loo ansixiyey monotherapy ahaan daaweynta bukaanada qaangaarka ah ee qaba kansarka naasaha ee HER2 ee aan la sixi karin ama metastatic kuwaas oo helay hal ama ka badan ka hor hababka anti-HER2 ee ku salaysan.
Enhertu waa mid si gaar ah loo farsameeyay HER2-directed antibody drug conjugate (ADC) in AstraZeneca iyo Daiichi Sankyo ay si wadajir ah u horumariyaan oo ay ganacsi u sameeyaan.
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 kansarka naasaha previously treated with trastuzumab and a taxan
Dalka Shiinaha, kansarka naasaha ayaa ah kansarka ugu badan ee ku dhaca haweenka, iyadoo in ka badan 415,000 xaaladood la filayo in la ogaado 2020.
1 Ku dhawaad 18% dhimashada kansarka naasaha adduunka ayaa ka dhacay Shiinaha 2020, iyadoo ku dhawaad 120,00 ay u dhinteen kansarka naasaha. 1 Qiyaastii mid ka mid ah shantii xaaladood ee kansarka naasaha waa HER2-positive. 2
Binghe Xu, MD, Professor iyo Agaasimaha Waaxda Caafimaadka Oncology, Cisbitaalka Kansarka iyo Isbitaalka Kansarka Machadka, Akadeemiyada Shiinaha ee Sayniska Caafimaadka, ayaa sheegay, "Oggolaanshahani wuxuu ka dhigan yahay guul muhiim ah oo loogu talagalay bulshada kansarka naasaha ee Shiinaha, sida bukaannada qaba HER2- Kansarka naasaha ee dheef-shiid kiimikaadka togan wuxuu sii wadaa inuu u baahan yahay doorashooyin daaweyn oo dheeraad ah. In kasta oo daawaynta bilawga ah ay jirto, bukaanada qaba kansarka naasaha ee HER2-positive metastatic naasaha ayaa had iyo jeer la kulma horumarka cudurka, taas oo muujinaysa muhiimada ay leedahay xakamaynta cudurada nidaamka hore iyo suurtagalnimada Enhertu si ay u caawiso bukaanada qaba kansarka naasaha metastatic kuwaas oo u qalma daaweynta.
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, Madaxa Qaybta Ganacsiga ee Daiichi Sankyo ee Aasiya, Koonfurta iyo Bartamaha Ameerika (ASCA), ayaa yidhi, "Enhertu waxay kordhinaysaa wakhtiga ka hor horumarka cudurka ama dhimashada waxayna gacan ka geysaneysaa dib u qeexidda natiijooyinka bukaanada hore loo daaweeyay HER2-hortagga kansarka naasaha ee metastatic, iyo hadda dhakhaatiirta Shiinaha waxay heli doonaan dawadan muhiimka u ah bukaannadooda. Ansixintan, Enhertu waxay awood u leedahay inay noqoto heer cusub oo daryeel gudaha Shiinaha loogu talagalay bukaannada qaba kansarka naasaha ee HER2-positive metastatic ee goobta-labaad."
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 tijaabada caafimaadka, 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.
Oggolaanshahan wuxuu daba socdaa NMPA's Breakthrough Therapy Designation ee Shiinaha iyo Dib u Eegista Mudnaanta Enhertu ee kansarka naasaha noocan ah sanadka 2022.
Notes
Kansarka naasaha iyo muujinta HER2
Kansarka naasuhu waa kansarka ugu badan waana mid ka mid ah sababaha ugu horreeya ee dhimashada kansarka la xidhiidha adduunka oo dhan.3 In ka badan laba milyan oo bukaan ah ayaa laga helay kansarka naasaha sanadka 2020, iyadoo ku dhawaad 685,000 ay u dhinteen adduunka oo dhan.3 Dalka Shiinaha, kansarka naasaha ayaa ah kansarka ugu badan ee haweenka, iyadoo in ka badan 415,000 bukaan laga helay 2020.1 Waxaa jiray ku dhawaad 120,000 dhimasho kansarka naasaha Shiinaha 2020, taasoo ka dhigan ku dhawaad 18% dhimashada kansarka naasaha adduunka.1 Ku dhawaad hal kiis shantii xaaladood ee kansarka naasaha ayaa loo arkaa HER2-positive.2
HER2 waa tyrosine kinase receptor korriin borotiin ah oo lagu muujiyay dusha noocyo badan oo burooyin ah oo ay ku jiraan kansarka naasaha, gastric, sambabada, iyo mindhicirka. iyo saadaal liidata ee kansarka naasaha.5
Inkastoo daawaynta bilowga ah ee trastuzumab iyo taxane, bukaanada qaba kansarka naasaha ee HER2-positive metastatic waxay inta badan la kulmi doonaan horumarka cudurka.6,7
QADAR-Naaska03
DESTINY-Breast03 waa caalami, madax-ilaa-madax, randomaysan, calaamad furan, tijaabada Wajiga III ee diiwaan gelinta qiimaynta waxtarka iyo badbaadada Enhertu 5.4mg/kg
Meesha ugu dambeysa ee waxtarka leh ee DESTINY-Naas03 waa badbaadada-horumar-la'aanta (PFS) ee ku salaysan dib u eegista dhexe ee madaxa-bannaan ee indho la'aanta ah (BICR). Badbaadada guud (OS) waa cabbir natiijada waxtarka labaad ee muhiimka ah. Dhibcaha kale ee waxtarka labaad waxaa ka mid ah heerka jawaabta ujeeddada (ORR), muddada jawaabta, PFS oo ku salaysan qiimaynta baaraha iyo badbaadada. Natiijooyinka asaasiga ah ee DESTINY-Naas03 ayaa lagu daabacay Wargeyska New England Journal of Medicine,8 Natiijooyinka PFS iyo OS ee la cusboonaysiiyay ee lagu daabacay Lancet.9
DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia, Europe, North America, Oceania and South America.
Enhertu
Enhertu waa HER2-ku haga ADC. Naqshadeynta iyadoo la adeegsanayo farsamada DXd ADC ee Daiichi Sankyo, Enhertu waa hogaanka ADC ee faylalka oncology ee Daiichi Sankyo iyo barnaamijka ugu horumarsan ee AstraZeneca's ADC ee sayniska. Enhertu wuxuu ka kooban yahay HER2 monoclonal antibody oo ku dheggan topoisomerase I inhibitor payload, derivative exatecan, iyada oo loo sii marayo isku xirka tetrapeptide ku salaysan xasillooner.
Enhertu (5.4mg/kg) ayaa laga oggolaaday in ka badan 40 waddan oo loogu talagalay daawaynta bukaannada qaangaarka ah ee qaba kansarka naasaha ee HER2-positive ee aan la soo saari karin ama metastatic kuwaas oo helay (ama hal ama in ka badan) ka hor anti-HER2-ku-saleysan nidaamka, ha ahaato metastatic dejinta ama goobta neoadjuvant ama adjuvant, oo ay sameeyeen soo noqoshada cudur inta lagu jiro ama gudaha lix bilood ka dib dhamaystirka daaweynta ku salaysan natiijooyinka ka soo baxa tijaabada QARAN-Naas03.
Enhertu (5.4mg/kg) ayaa laga oggolaaday in ka badan 30 waddan oo loogu talagalay daawaynta bukaannada qaangaarka ah ee leh HER2-hoose ee aan la soo saari karin ama metastatic (immunohistochemistry [IHC] 1+ ama IHC 2+/in-situ hybridization [ISH]-) kansarka naasaha kaasoo lagu helay daawayn nidaameed hore oo ku saabsan goobta metastatic ama soo noqnoqda cudurka inta lagu jiro ama gudaha lix bilood ka dib dhamaystirka daaweynta kemotherabi ee ku salaysan natiijooyinka ka soo baxa tijaabada QARANKA-Naaska04.
Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic kansarka sanbabada ee aan yareyn 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 kuwaas oo helay nidaam trastuzumab ku salaysan hore oo ku salaysan natiijooyinka ka soo baxay tijaabada DESTINY-Gastric01 iyo/ama DESTINY-Gastric02.
Enhertu barnaamijka horumarinta
Barnaamij horumarineed oo caalami ah oo dhamaystiran ayaa socda kaas oo lagu qiimaynayo waxtarka iyo badbaadada Enhertu monotherapy across multiple HER2-targetable cancers including breast, gastric, lung and kansarka mindhicirka. Trials in combination with other anticancer treatments, such as immunotherapy, sidoo kale waa ay socdaan.
Daiichi Sankyo iskaashiga
Shirkadda Daiichi Sankyo, Limited (TSE: 4568) [oo loo yaqaan Daiichi Sankyo] iyo AstraZeneca waxay galeen iskaashi caalami ah si ay si wadajir ah u horumariyaan oo ay uga ganacsadaan Enhertu (HER2-ku hagayo ADC) bishii Maarj 2019, iyo datopotamab deruxtecan (DS-1062; ADC TROP2-hagaha) bishii Luulyo 2020, marka laga reebo Japan halkaas oo Daiichi Sankyo ay ilaaliso xuquuqaha gaarka ah. Daiichi Sankyo ayaa mas'uul ka ah wax soo saarka iyo sahayda Enhertu iyo datopotamab deruxtecan.
AstraZeneca ee kansarka naasaha
Iyada oo ay kaxeyso fahamka sii kordhaya ee bayoolajiga kansarka naasaha, AstraZeneca waxay bilaabaysaa inay caqabad ku noqoto, oo dib u qeexdo, jaantuska caafimaad ee hadda jira ee sida kansarka naasaha loo kala saaro oo loo daweeyo si loo gaarsiiyo xitaa daaweyn waxtar leh bukaannada u baahan kansarka naasaha oo sabab u ah dhimashada.
AstraZeneca waxay leedahay faylal dhammaystiran oo xeryahooda la ansixiyay iyo kuwo rajo leh oo horumarin ah kuwaas oo ka faa'iideysanaya habab kala duwan oo ficil ah si wax looga qabto bayoloji ahaan kala duwan ee buro kansarka naasaha.
Iyadoo Enhertu (trastuzumab deruxtecan), HER2-ku hagayo ADC, AstraZeneca iyo Daiichi Sankyo waxay rabeen inay hagaajiyaan natiijooyinka HER2-positive-ka hore iyo HER2-hoos u dhaca kansarka naasaha waxayna sahamiyaan awooddooda khadadka hore ee daaweynta iyo goobaha kansarka naasaha cusub.
Kansarka naasaha ee HR ee togan, AstraZeneca waxay sii wadaa inay hagaajiso natiijooyinka daawooyinka aasaasiga ah Faslodex (fulvestrant) iyo Zoladex (goserelin) oo ujeedadeedu tahay inay dib u qaabayso booska HR-togan ee jiilka soo socda ee SERD iyo daawada cusub ee camizestrarant, iyo sidoo kale suurtogalnimada fasalka koowaad ee AKT kinase inhibitor, capivasertib. AstraZeneca waxay sidoo kale la kaashanaysaa Daiichi Sankyo si ay u sahamiso kartida TROP2-ku hagayo ADC, datopotamab deruxtecan, ee goobtan.
Ka -hortagga PARP Lynparza (olaparib) waa ikhtiyaar daawaynta la bar tilmaameedsaday oo hore loo bartay iyo bukaannada kansarka naasaha ee dheef-shiid kiimikaadka leh ee leh isbeddelka BRCA ee la dhaxlo. AstraZeneca iyo MSD (Merck & Co., Inc. ee Maraykanka iyo Kanada) waxay sii wadaan cilmi-baarista Lynparza goobahan iyo in la sahamiyo awoodeeda cudurro hore.
Si loo keeno xulashooyinka daawaynta aadka loogu baahan yahay bukaanada qaba kansarka naasaha saddex-laaban, oo ah nooc qallafsan oo kansarka naasaha ah, AstraZeneca waxay qiimeyneysaa awoodda datopotamab deruxtecan oo keliya iyo marka lagu daro immunotherapy Imfifinzi (durvalumab), capivasertib oo ay weheliso kiimoterabi, iyo Imfifinzi marka lagu daro daawooyinka kale ee kansarka, oo ay ku jiraan Lynparza iyo Enhertu.
AstraZeneca ee Oncology
AstraZeneca waxay hogaaminaysaa kacaanka oncology iyada oo hamiga ku leh in ay bixiso daawaynta kansarka nooc kasta, iyada oo raacaysa sayniska si loo fahmo kansarka iyo dhammaan kakanaanta si loo ogaado, loo horumariyo, oo loo gaarsiiyo daawooyinka nolosha beddela bukaanka.
Shirkaddu waxay diiradda saartaa qaar ka mid ah kansarrada ugu adag. Waa iyada oo loo marayo hal-abuurnimo joogto ah in AstraZeneca ay dhistay mid ka mid ah faylalka iyo dhuumaha ugu kala duwan ee warshadaha, iyada oo awood u leh in ay kiciso isbeddellada ku-dhaqanka daawada iyo beddelka khibradda bukaanka.
AstraZeneca waxay leedahay aragti ah inay dib u qeexdo daryeelka kansarka iyo, hal maalin, tirtirto kansarka sabab dhimasho.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) waa shirkad caalami ah, saynis uu hogaaminayo biopharmaceutical shirkad diiradda saara daahfurka, horumarinta, iyo ganacsiga daawooyinka dhakhtar qoro ee Oncology, Cudurada Naadirka ah, iyo BioPharmaceuticals, oo ay ku jiraan Wadnaha, kelyaha & dheefshiidka, iyo neefsashada. & Immunology. Iyada oo ku saleysan Cambridge, UK, AstraZeneca waxay ka shaqeysaa in ka badan 100 waddan, iyo dawooyinkeeda cusub waxaa isticmaala malaayiin bukaanno ah oo adduunka oo dhan ah.
tixraacyada
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2. Ahn S, iyo al. Heerka HER2 ee kansarka naasaha: isbeddellada tilmaamaha iyo arrimaha adkeynaya tarjumaada. J Pathol Transl Med. 2020; 54(1): 34-44.
3. Sung H, iyo al. Tirakoobka Kansarka Caalamiga ah 2020: Qiyaasta GLOBOCAN ee Dhacdooyinka iyo Dhimashada Adduunka oo dhan ee 36 Kansarka ee 185 Waddan. CA Kansarka J Clin. 2021; 10.3322/caac.21660.
4. Iqbal N, iyo al. Soo-dhaweeyaha Kobaca Epidermal ee Aadanaha 2 (HER2) ee Kansarka: Cadaadis xad dhaaf ah iyo Saamaynta Daweynta. Mol Biol Int. 2014; 852748.
5. Pillai R, et al. HER2 mutations in lung adenocarcinomas: A report from the Kansarka Sambabka Mutation Consortium. Kansarka. 2017;1;123(21):4099-4105.
6. Barok M, iyo al. Trastuzumab emtansine: habka ficilka iyo caabbinta daroogada. Kansarka Naasaha Res. 2014; 16 (2): 209.
7. Nader-Marta G, iyo al. Sida aan u daaweyno bukaanada qaba kansarka naasaha ee HER2 togan. ESMO Furan. 2022; 7:1.
8. Cortes J, iyo al. Trastuzumab Deruxtecan iyo Trastuzumab Emtansine ee Kansarka Naasaha. N Engl J Med. 2022; 386: 1143-1154.
9. Hurvitz S, iyo al. Trastuzumab deruxtecan iyo trastuzumab emtansine ee bukaanada qaba kansarka naasaha ee HER2-positive metastatic: Natiijooyinka la cusboonaysiiyay ee DESTINY-Naas03, calaamad aan kala sooc lahayn, calaamad furan, tijaabada wajiga 3. Lancet. 2022 Dec 6;S0140-6736(22)02420-5.
