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Imfinzi and Imjudo with chemotherapy approved in the US for patients with metastatic non-small cell lung cancer

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Approval based on POSEIDON Phase III trial results, which showed significant survival benefit with a limited course of Imjudo added to Imfinzi and chemotherapy.

AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy has been approved in the US for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

The approval by the Food and Drug Administration (FDA) was based on the results from the POSEIDON Phase III trial. Patients treated with a limited course of five cycles of the anti-CTLA-4 antibody Imjudo added to Imfinzi plus four cycles of platinum-based chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options (based on a hazard ratio [HR] of 0.77; 95% CI 0.65-0.92; p=0.00304). An estimated 33% of patients were alive at two years versus 22% for chemotherapy. This treatment combination also reduced the risk of disease progression or death by 28% compared to chemotherapy alone (HR 0.72; 95% CI 0.60-0.86; p=0.00031).

Updated results from the POSEIDON Phase III trial after approximately four years of follow-up presented at the European Society of Medical Oncology (ESMO) Congress 2022 and published in the Journal of Clinical Oncology demonstrated sustained survival benefit, improving overall survival (OS) by 25% compared to chemotherapy alone (HR 0.75; 95% CI 0.63-0.88). An estimated 25% of patients treated with the combination were alive at three years versus 13.6% for those treated with chemotherapy alone. The safety profile for Imjudo plus Imfinzi and chemotherapy was consistent with the known profiles of each medicine, and no new safety signals were identified.

In the US, lung cancer is the second most commonly diagnosed cancer, with more than 236,000 patients expected to be diagnosed in 2022.1 For patients with metastatic NSCLC, prognosis is particularly poor, as only approximately 8% will live beyond five years after diagnosis.2

Melissa Johnson, MD, Director of Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee, and a lead investigator in the POSEIDON Phase III trial, said: “Metastatic non-small cell lung cancer remains a significant treatment challenge because many patients’ tumours do not respond well to standard therapies, including checkpoint inhibitors. The approval of this dual immunotherapy regimen with chemotherapy introduces a new, generally well-tolerated treatment option for patients with this devastating disease and gives them the chance to benefit from the long-term survival advantage seen with CTLA-4 inhibition.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval underscores the importance of delivering novel treatment combinations that extend survival in metastatic non-small cell lung cancer, a complex setting where many patients still face a dismal prognosis. This marks the second indication for Imjudo added to Imfinzi in just a few weeks following its approval in unresectable liver cancer, reinforcing the benefits of this new medicine and our commitment to improving patient outcomes in cancer settings with continued unmet need.”

Regulatory applications are also currently under review in Europe, Japan and several other countries for this indication based on the POSEIDON results.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial. Imfinzi is also approved in the US, the EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial. Imfinzi is approved in the US and several other countries in combination with chemotherapy for the treatment of locally advanced or metastatic biliary tract cancer based on the TOPAZ-1 Phase III trial, and it is approved with Imjudo in the US for the treatment of unresectable hepatocellular carcinoma based on the HIMALAYA Phase III trial.

Notes

Stage IV NSCLC
Lung cancer is the second most common form of cancer globally, with more than two million patients diagnosed in 2020.3Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC. Within NSCLC, patients are classified as squamous, representing 25-30% of patients, or non-squamous, in approximately 70-75% of patients.4-6

POSEIDON
The POSEIDON trial was a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi plus platinum-based chemotherapy, or Imfinzi, Imjudo and chemotherapy, versus chemotherapy alone in the 1st-line treatment of 1,013 patients with metastatic NSCLC. The trial population included patients with either non-squamous or squamous disease, and the full range of PD-L1 expression levels. POSEIDON excluded patients with certain epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.

In the experimental arms, patients were treated with a flat dose of 1,500mg of Imfinzi, or Imfinzi and 75mg of Imjudo with up to four cycles of chemotherapy every three weeks, followed by maintenance treatment with Imfinzi once every four weeks, or Imfinzi and a fifth dose of 75mg of Imjudo given at week 16. In comparison, the control arm allowed up to six cycles of chemotherapy. Pemetrexed maintenance treatment was allowed in all arms in patients with non-squamous disease if given during the induction phase. Nearly all patients with non-squamous disease (95.5%) had pemetrexed and platinum, while the majority of patients with squamous disease receiving chemotherapy (88.3%) received gemcitabine and platinum.

Primary endpoints included progression-free survival (PFS) and OS for the Imfinzi plus chemotherapy arm. Key secondary endpoints included PFS and OS in the Imfinzi plus Imjudo and chemotherapy arm. As both PFS endpoints were met for Imfinzi plus chemotherapy and Imfinzi, Imjudo and chemotherapy, the prespecified statistical analysis plan allowed for testing OS in the Imfinzi plus Imjudo and chemotherapy arm. The trial was conducted in more than 150 centres across 18 countries, including the US, Europe, South America, Asia and South Africa.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its approved indications in lung cancer, Imfinzi is also the only approved immunotherapy in unresectable or metastatic biliary tract cancer and hepatocellular carcinoma (in combination with Imjudo), and is also approved for previously treated patients with advanced bladder cancer in several countries.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several gastrointestinal (GI) cancers, ovarian cancer, endometrial cancer and other solid tumours. 

Imjudo
Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

Imjudo is also approved in combination with Imfinzi for the treatment of unresectable hepatocellular carcinoma (HCC) and is being tested in combination with Imfinzi across multiple tumour types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in immuno-oncology (IO)
AstraZeneca has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours.

AstraZeneca aims to reimagine cancer care and help transform outcomes for patients with Imfinzi as a single treatment and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also exploring next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer.

AstraZeneca is boldly pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

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
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References

  1. Lungevity. Lung Cancer Statistics. Available at: https://www.lungevity.org/for-supporters-advocates/lung-cancer-awareness/lung-cancer-statistics#1. Accessed November 2022.
  2. American Cancer Society. Lung Cancer Survival Rates. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed November 2022.
  3. WHO. International Agency of Cancer Research. Lung Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed November 2022.
  4. Abernethy AP, et al. Real-world first-line treatment and overall survival in non-small cell lung cancer without known EGFR mutations or ALK rearrangements in US community oncology setting. PLoS ONE. 2017;12(6):e0178420.
  5. Cheema PK, et al. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol. 2019;26(1):37-42.
  6. Cancer.net. Lung Cancer – Non-Small Cell: Introduction. Available at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction. Accessed November 2022.
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Nordea Bank Abp: Återköp av egna aktier den 09.12.2022

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Nordea Bank Abp
Börsmeddelande – Förändringar i återköpta aktier
09.12.2022 kl. 22.30 EET

Nordea Bank Abp (LEI-kod: 529900ODI3047E2LIV03) har den 09.12.2022 slutfört återköp av egna aktier (ISIN-kod: FI4000297767) enligt följande:

Handelsplats (MIC-kod)

Antal aktier

Viktad snittkurs/aktie, euro*, **

Kostnad, euro*, **

XHEL

349 563

 9,92

3 466 860,97

CEUX

290 089

 9,93

2 880 588,25

TQEX

34 660

 9,95

 344 701,54

XSTO

290 262

 9,94

2 886 283,74

XCSE

35 411

 9,92

 351 188,09

Summa

 999 985

 9,93

9 929 622,58

* Växelkurser som använts: SEK till EUR 10,8811 och DKK till EUR 7,4375
** Avrundat till två decimaler

Den 18 juli 2022 tillkännagav Nordea ett program för återköp av egna aktier till ett värde av högst 1,5 md euro med stöd av det bemyndigande som gavs av Nordeas ordinarie bolagsstämma 2022. Återköpet av egna aktier utförs genom offentlig handel i enlighet med Europaparlamentets och rådets förordning (EU) nr 596/2014 av den 16 april 2014 (marknadsmissbruksförordningen) och Kommissionens delegerade förordning (EU) 2016/1052.

Efter de redovisade transaktionerna innehar Nordea 16 827 537 egna aktier för kapitaloptimeringsändamål och 6 073 651 egna aktier för ersättningsändamål.

Uppgifter om respektive transaktion finns som en bilaga till detta meddelande.

För Nordea Bank Abp:s räkning,
Citigroup Global Markets Europe AG

För ytterligare information:

Matti Ahokas, chef för investerarrelationer, +358 9 5300 8011
Group Communication, +358 10 416 8023 eller [email protected]

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KOMMUNIKÉ FRÅN THINC JETTY COLLECTIVES EXTRA BOLAGSSTÄMMA 2022

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REGULATORY

Thinc Jetty Collective AB (publ) har idag hållit extra bolagsstämma. Stämman beslutade i enlighet med de förslag som styrelsen lagt fram.

Stämman beslutade om:

  • godkännande av förvärv av aktier i Tigerton AB och förvärv av aktier i Kunskapskraft & Media AB.
  • om incitamentsprogram till ledande nyckelpersoner och anställda genom emission  av 10 000 000 teckningsoptioner enligt styrelsens förslag där lösenkursen fastställdes till 0,45 SEK per aktie.
  • ny bolagsordning genom om ändring av bolagets företagsnamn till Thinc Collective AB (publ)

Den extra bolagsstämman ägde rum genom poströstning.

För ytterligare information, vänligen kontakta:
Anders Wallqvist, VD Thinc Jetty Collective AB
[email protected]

Thinc Jetty Collective är verksamma inom kommunikationsbranschen och koncernen erbjuder en grupp av bolag inom system, kommunikation och struktur. Bolagen tänker ut och genomför idéer till sina kunder. Gruppens kompetensområden sträcker sig från data, analys, teknikutveckling och SaaS system till kommunikation, media, PR och brand experience. Koncernen riktar sig till kunder oavsett bransch med behov av sammanhållen kommunikation. Thinc Jetty Collective är verksamma inom Norden.

Läs mer på thinccollective.se

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Överenskommelse nådd i EU för Karlsbro (L)s batterilagstiftning

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Europaparlamentet, Kommissionen och Rådet har just enats om förslaget om en europeisk batteriförordning. Liberalernas Europaparlamentariker Karin Karlsbro som varit den liberala gruppens förhandlare är nöjd över resultatet av trialogförhandlingen som innebär en mer ambitiös lagstiftning än Kommissionens grundförslag. 

“Utan batterier och elektrifiering klarar vi inte våra ambitiösa klimatmål. Den nya lagen ställer höga krav både när det gäller batteriets klimat- och miljöpåverkan och ger konsumenten större möjlighet att enkelt göra egna klimatval. Jag är glad att både Rådet och Kommissionen gått parlamentet till mötes för se till att göra förslaget skarpare” säger Karlsbro.

Med batterier kan allt från små hushållsapparater till stora transportmedel och enorma industrier bryta sitt beroende av fossila bränslen. När efterfrågan på batterier ökar då vi ställer om från fossildrivna fordon och produktionsprocesser till el kommer batteriernas klimatpåverkan spela en allt större roll. Batteriförordningen är ett helt nytt sätt att lagstifta på miljöområdet som kommer att följa batteriet i alla faser – produktion, konsumtion och återvinning. 

“En cirkulär marknad skapas genom krav på att nya batterier måste innehålla en viss andel återvunnet material. För att garantera att vi inte producerar batterier i Europa på bekostnad av miljö och välstånd i andra länder kommer batterier på den europeiska marknaden att omfattas av så kallade “due diligence”- regler för att säkerställa skydd av mänskliga rättigheter och miljö genom hela produktionskedjan” säger Karin Karlsbro.

Karlsbro framhåller lagstiftningen som särskilt viktig för Sverige, som ligger i framkant av den växande industrin för hållbara batterier.  

“Hållbara batterier från EU behövs för energiomställningen och är ett sätt för oss att klippa beroendet av råvaror från odemokratiska fossilnationer. Sveriges batteriproduktion ger oss möjligheten att minska både den globala uppvärmningen och diktaturers maktposition i den globala ekonomin. Vi är, med EU:s hjälp, på god väg att bli Europas batteri-stormakt” avslutar Karlsbro.

För ytterligare kommentarer eller frågor kontakta:
Linnéa Bjärum
[email protected]
+46 73 427 56 92

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