Connect with us

Marknadsnyheter

Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive advanced gastric cancer

Published

on

Based on DESTINY-Gastric02 which showed AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01 which showed improved overall survival compared to chemotherapy.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DESTINY-Gastric02 and the DESTINY-Gastric01 Phase II trials.

In DESTINY-Gastric02, conducted in patients from North America and Europe, updated results showed treatment with Enhertu resulted in a confirmed objective response rate (ORR) of 41.8% as assessed by independent central review (ICR). Median duration of response (DoR) was 8.1 months and median overall survival (OS) was 12.1 months. Primary results from the DESTINY-Gastric02 Phase II trial were presented at the 2021 European Society for Medical Oncology (ESMO) Congress, with the updated data presented at ESMO 2022.1

In DESTINY-Gastric01, conducted in patients from Japan and South Korea, updated results showed treatment with Enhertu resulted in an ORR of 51.3% versus 14.3% with chemotherapy (irinotecan or paclitaxel). Patients treated with Enhertu had a 40% reduction in the risk of death versus patients treated with chemotherapy (based on a hazard ratio of 0.60; 95% confidence interval: 0.42-0.86, p=0.01) with a median OS of 12.5 months versus 8.9 months. Additionally, confirmed ORR, a major efficacy outcome, was 42.0% with Enhertu versus 12.5% with chemotherapy as assessed by ICR. The primary analysis was published in The New England Journal of Medicine,2 with the updated data presented at the 2021 American Society of Clinical Oncology Annual Meeting.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Gastric cancer is usually diagnosed in the advanced stage in many European countries and patients face high mortality rates. If approved, Enhertu would be the first HER2-directed medicine for patients with advanced gastric cancer in the European Union in more than a decade.”

Ken Takeshita, Global Head, Oncology R&D, Daiichi Sankyo, Inc, said:Enhertu is the first HER2-directed medicine to demonstrate a significant improvement in overall survival compared to chemotherapy in patients with gastric cancer following initial treatment with a HER2-directed medicine in the advanced or metastatic setting. The CHMP opinion recognises the high unmet need in this patient population and brings us one step closer to bringing this medicine to patients with gastric cancer in Europe.”

In both trials, the safety profiles observed in patients treated with Enhertu were consistent with those seen in other trials of Enhertu with no new safety signals identified.

Enhertu is approved in the US and several other countries for locally advanced or metastatic HER2-positive gastric cancer.

Notes

HER2-positive gastric cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fourth highest leading cause of cancer mortality, with a five-year global survival rate of 5% to 10% for advanced or metastatic disease.3-5 Approximately one million new patients were diagnosed with gastric cancer in 2020, with 768,000 deaths reported globally.6 In Europe, approximately 136,000 cases of gastric cancer are diagnosed annually, and Eastern Europe has the second highest incidence of gastric cancer worldwide after Eastern Asia.5-6 Gastric cancer is the sixth leading cause of cancer death in Europe and is typically diagnosed in the advanced stage. Even when diagnosed in earlier stages of the disease, the survival rate remains modest.5-7

Approximately one in five gastric cancers are HER2-positive.8,9 HER2 is a tyrosine kinase receptor growth promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers.8 HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification.9

Recommended first-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy.10 For patients with metastatic gastric cancer that progresses following initial treatment with a trastuzumab-based regimen, treatment options are limited, and in many regions in the world there are no additional HER2 directed medicines available.2,11,12

DESTINY-Gastric02
DESTINY-Gastric02 is an open-label, single-arm Phase II trial in Western patients evaluating the efficacy and safety of Enhertu (6.4mg/kg) in patients with HER2-positive metastatic and/or unresectable gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint of DESTINY-Gastric02 is confirmed ORR based on ICR. Secondary endpoints include progression-free survival (PFS), OS, DoR and safety.

DESTINY-Gastric02 enrolled 79 patients at multiple sites in North America and Europe. For more information about the trial, visit ClinicalTrials.gov.

DESTINY-Gastric01
DESTINY-Gastric01 is a randomised, open-label Phase II trial evaluating the efficacy and safety of Enhertu (6.4mg/kg) in patients from Japan and South Korea with primarily HER2-positive (defined as immunohistochemistry [IHC] 3+ or IHC 2+/in-situ hybridisation [ISH]+) advanced gastric cancer or GEJ adenocarcinoma whose tumours have progressed on two or more prior treatment regimens including fluoropyrimidine (5-FU), platinum chemotherapy and trastuzumab. Patients were randomised 2:1 to receive Enhertu or physician’s choice of chemotherapy (paclitaxel or irinotecan monotherapy).

The primary endpoint of DESTINY-Gastric01 is ORR. Secondary endpoints include OS, PFS, DoR, disease control rate and time to treatment failure, as well as pharmacokinetic and safety endpoints.

DESTINY-Gastric01 enrolled 187 patients at multiple sites in Japan and South Korea. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 35 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in several countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Enhertu (5.4mg/kg) is approved in Brazil and the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer 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 of 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 several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Regulatory applications for Enhertu in breast and gastric cancer are currently under review in several other countries based on the DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Gastric01 and DESTINY-Gastric02 trials, respectively.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in gastrointestinal cancers
AstraZeneca has a broad development programme for the treatment of gastrointestinal (GI) cancers across several medicines and a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.13

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers.

Enhertu, a HER2-directed antibody drug conjugate, is approved in the US and several other countries for HER2-positive advanced gastric cancer and is being assessed in colorectal cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Imfinzi (durvalumab) is approved in the US and several other countries in combination with chemotherapy (gemcitabine plus cisplatin) for advanced biliary tract cancer and in the US in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma. Imfinzi is being assessed in combinations, including with Imjudo, in liver, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

Lynparza (olaparib), a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

References

  1. Updated analysis of DESTINY-Gastric02. Available at: https://oncologypro.esmo.org/meeting-resources/esmo-congress/updated-analysis-of-destiny-gastric02-a-phase-ii-single-arm-trial-of-trastuzumab-deruxtecan-t-dxd-in-western-patients-pts-with-her2-positive. Accessed November 2022.
  2. Shitara K, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med 2020; 382:2419-2430.
  3. Casamayor M, et al. Targeted literature review of the global burden of gastric cancer. Ecancermedicalscience. 2018; 12:883;12:883.
  4. SEER Cancer Stat Facts: Stomach Cancer. Available at: https://seer.cancer.gov/statfacts/html/stomach.html. Accessed November 2022.
  5. Sung. H et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021; 10.3322/caac.21660.
  6. WHO. International Agency of Cancer Research. Cancer Today. Stomach Incidence. 2020. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf. Accessed November 2022.
  7. Cancer Research UK. Stomach Cancer Survival Statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/stomach-cancer/survival#heading-Zero. Accessed November 2022.
  8. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014; 2014:852748.
  9. Abrahao-Machado LF, et al. HER2 testing in gastric cancer: An update. World J Gastroenterol. 2016; 22(19):4619-4625.
  10. Orditura M, et al. “Treatment of gastric cancer.” World Journal of Gastroenterology: WJG 20.7 (2014): 1635.
  11. Thuss-Patience PC, et al. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017; 18(5):640-653.
  12. Satoh T, et al. Lapatinib Plus Paclitaxel Versus Paclitaxel Alone in the Second-Line Treatment of HER2-Amplified Advanced Gastric Cancer in Asian Populations: TyTAN—A Randomized, Phase III Study. J Clin Oncol.2014; 32(19):20392049.
  13. WHO. World Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed November 2022.
Continue Reading
Click to comment

Leave a Reply

Din e-postadress kommer inte publiceras. Obligatoriska fält är märkta *

Marknadsnyheter

Lyxig SUV från Hongqi premiärvisas på eCarExpo

Published

on

By

Den kinesiska biltillverkaren Hongqi visar upp sin nya helelektriska SUV, E-HS9, under eCarExpo i Göteborg den 2- 4 december. Bilmärket Hongqi, som är framstående inom kinesisk fordonsexpertis och lyx, har kraftigt ökat sin närvaro på både den svenska och norska marknaden under de senaste åren. Mycket tack vare att båda länder ligger långt framme när det gäller elfordon och  laddinfrastruktur.

Hongqi EHS9 SUV

När eCarExpo går av stapeln i år i Göteborg finns den kinesiska fordonstillverkaren på plats för första gången och visar upp sin SUV E-HS9.  SUVen innehåller en uppsjö av högteknologiska smarta funktioner som konkurrerar med några av de främsta europeiska elbilstillverkarna. Något som svenska bil- och teknikentusiaster får chansen att se och testa under eCarExpo.

E-HS9 finns i tre varianter: COMFORT, PREMIUM och EXCLUSIVE.

Alla varianter har tre sittrader, även om Exclusive-modellen har ett säte mindre för extra utrymme för passagerarna. SUV:en har 21-tumshjul och en elegant design. SUV:en kommer i färgerna Dark Night Black, Silver Grey och Alpine White med möjlighet att välja en takfärg som skiljer sig från karossfärgen.

Dörrhandtagen dras automatiskt tillbaka när bilen parkeras eller är i rörelse och instegsbelysning tänds när man går in i eller lämnar bilen.  Invändigt finns en intelligent, automatjusterande ratt,   fyra oberoende klimatzoner, ett ultrabrett panoramatakfönster och krockkuddar. Basmodellen COMFORT kostar från 899 900 SEK, PREMIUM från 1 079 900 SEK och EXCLUSIVE från 1 169 900 SEK.

För mer information:

Sofia Wassén, Project Manager Marketing, mail: [email protected]
Telefon: +46 31-790 04 00
Hemsida: www.hongqi.se

Om Hongqi

Hongqi är Kinas äldsta biltillverkningsföretag och startade redan 1958. Under 1960- och 1970-talen var Hongqi-bilen favorit som premiumval och användes ofta vid diplomatbesök i Kina. De senaste tio åren har fokus varit att tillverka bilar för den genomsnittlige konsumenten och 2018 togs ett helt nytt designkoncept och ett utökat sortiment bilar fram. Sedan dess har Hongqi haft en explosiv tillväxt på de kinesiska hemmamarknaderna och sextiofaldigt ökat sin försäljning. Hongqi introducerar nu sina bilar på fler marknader i Asien, Mellanöstern och Europa.

Continue Reading

Marknadsnyheter

Shopping för nästan 9,3 miljarder under årets Black Week

Published

on

By

Black week ökade i popularitet jämfört med i fjol. I år säger konsumenterna att de har handlat för 9,3 miljarder* kronor under Black week. Det är en ökning med 11 procent jämfört med förra året. Närmare hälften (48 %) valde att handla under Black week och en stor andel hade planerat sina inköp i förväg. Det visar en undersökning** som Kantar Sifo har genomfört på uppdrag av PostNord. 

Det var mycket som bäddade för en stor shoppingfest under Black Week. Många e-handlare har suttit på stora lager och har därmed haft generösa erbjudanden samtidigt som konsumenterna har blivit betydligt mer prismedvetna och planerat sina inköp.

– Att Black week har omfamnats av konsumenterna i år, märker vi av på våra terminaler runt om i Sverige, där det har varit högtryck. Totalt hanterade vi nästan 1,2 miljoner paket och varubrev dygnet mellan söndag och måndag som brukar vara toppdygnet efter Black week. Under veckan har volymerna varit fortsatt höga, säger Mathias Krümmel, vd PostNord Sverige.

Merparten (77 %) av konsumenterna gjorde en del av sina inköp via nätet samtidigt som andelen som handlade i fysisk butik återigen har ökat (46 %) och är nu tillbaka på samma nivå som innan pandemin. Endast 10 procent av de som handlade under Black week handlade från utlandet, vilket är en lägre andel än under de senaste åren, något som har gynnat de svenska e-handelsföretagen.  

– Att det skulle bli konsumenternas Black week fanns flera indikationer på, något som vi förutspådde redan i E-barometern för tredje kvartalet. Några av förklaringarna till ökningen i år är att många företag har suttit med stora lager och därför haft väldigt bra kampanjer under veckan. Samtidigt har fler konsumenter blivit mer prismedvetna och gjort både planerade inköp och julhandlat under Black week, säger Mathias Krümmel.

Fakta från undersökningen: 

  • 94 procent av svenskarna uppmärksammande Black week 
  • 48 procent valde att handla under rean 
  • 46 procent handlade i fysiska butiker (flerval)
  • 77 procent handlade i webbutik (flerval)
  • Drygt hälften (54 %) handlade enbart i webbutik under Black week  
  • De populäraste kategorierna att handla var:
    • kläder och skor (59 %) 
    • hemelektronik (33 %) 
    • skönhet och hälsa (31 %)
  • 14 procent handlade bara julklappar, 26 procent julklappar samt saker till sig själv och 40 procent köpte endast saker till sig själv. 
  • 53 procent uppgav att de mest gjort planerade inköp.  
  • Av de som uppgett att de konsumerat mindre i år svarade 32 procent att det berodde på försämrad ekonomisk situation på grund av allmänt höjda priser och levnadskostnader. 

* Fasta priser 

** Undersökningen genomfördes av Kantar Sifo 26–27 november bland ett riksrepresentativt urval av Sveriges befolkning 18–79 år. Frågorna ställdes om perioden 21–27 november, och undersökningen genomfördes med Kantar Sifos webbpanel. 

För ytterligare information kontakta:
PostNord Medierelationer, tel: 010-436 10 10, e-post: [email protected]

Vi gör vardagen enklare! PostNord är ledande inom paket- och logistiktjänster till, från och inom Norden. Vi säkerställer postservicen till alla privatpersoner och företag i Sverige och Danmark oavsett var de bor och verkar. PostNord kopplar ihop företag, myndigheter och privatpersoner och möjliggör affärer, handel och kommunikation i Norden. Genom vår expertis och ett starkt distributionsnät utvecklar vi förutsättningarna för morgondagens e-handel, distribution, logistik och kommunikation i Norden. 2021 hade koncernen cirka 28 500 anställda och en omsättning på 40,7 miljarder SEK. Moderbolaget är ett svenskt publikt bolag med koncernkontor i Solna. Besök oss på www.postnord.com 

Continue Reading

Marknadsnyheter

Pressinbjudan till nordisk konferens om personlig assistans – framgångssagan och utmaningarna

Published

on

By

Riksföreningen JAG anordnar en nordisk konferens den 23 december i Stockholm i samarbete med Föreningen JAG i Finland och Foreningen JAG i Norge. Konferensen arrangeras med stöd av Nordens välfärdscentrum.

Välkommen till en spännande genomlysning av personlig assistans som framgångsfaktor och förutsättning för att förverkliga FNs konventioner om rättigheter för barn och vuxna med funktionsnedsättning.

Intressanta programpunkter om IQ-diskriminering, mänskliga rättigheter och presonlig assistans där vi gästas av politiker, forskare och jurister. Ta del av det fullständiga programmet i bifogad pdf.

Delta på plats på Klara Södra Kyrkogata 1 eller följ programpunkterna på länk.

Länk till fredagens sändning, 2 december kl 1117

Länk till lördagens sändning, 3 december kl 9:30–15

Varmt välkommen!

Cecilia Blanck
Verksamhetsansvarig Riksföreningen JAG
08-789 30 00
[email protected]

JAG är en ideell riksförening för personer med flera omfattande funktionsnedsättningar, varav en avser den intellektuella förmågan. JAG arbetar för att medlemmarna ska kunna leva sina liv fullt ut, på sina egna villkor, med bästa möjliga personliga assistans. JAGs assistanskooperativ styrs av medlemmarna och drivs utan vinstintresse.

Taggar:

Continue Reading

Trending

Copyright © 2017 Zox News Theme. Theme by MVP Themes, powered by WordPress.