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First HER2-directed anesthetic accustomed for patients with belly blight in a decade

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AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been accustomed in the US for the assay of developed patients with locally avant-garde or metastatic HER2-positive belly or gastroesophageal alliance (GEJ) adenocarcinoma who accept accustomed a above-mentioned trastuzumab-based regimen.

In the US, belly blight is best frequently diagnosed in the avant-garde stage, with alone about 5% of patients actual above bristles years. 1,2 About one in bristles belly cancers are HER2 positive.3

The approval by the Food and Biologic Administration (FDA) was based on the absolute after-effects from the randomised DESTINY-Gastric01 Phase II balloon conducted in Japan and South Korea. In the trial, Enhertu accustomed a statistically cogent and clinically allusive beforehand in all-embracing adaptation (OS) and cold acknowledgment bulk (ORR) against chemotherapy (irinotecan or paclitaxel) in patients with avant-garde belly blight or GEJ adenocarcinoma who had progressed on at atomic two or added above-mentioned regimens including trastuzumab added a fluoropyrimidine- and platinum-based chemotherapy combination.4

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Ronan Kelly, MD, MBA, Director of the Charles A. Sammons Blight Center and the W.W. Caruth, Jr. Chair of Immunology at Baylor University Medical Center, Dallas, Texas, US, said: “Patients with metastatic HER2-positive belly blight with progression afterward 1st-line assay accept historically faced poor outcomes, including low acknowledgment to assay and accelerated ache progression. This approval represents the aboriginal time a HER2-directed anesthetic has accustomed a cogent beforehand in adaptation compared to chemotherapy afterward antecedent assay in the metastatic setting, and it has the abeyant to become the new accepted of affliction for this accommodating population.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Today’s approval of Enhertu represents the aboriginal HER2-directed anesthetic accustomed in a decade for patients with HER2-positive metastatic belly cancer. The after-effects from the DESTINY-Gastric01 balloon highlight the abeyant to change analytic practice, assuming a 41 per cent beforehand in adaptation and a acknowledgment bulk added than three times college with Enhertu compared to chemotherapy. We are captivated to accompany this important anesthetic to added patients and physicians in the US.”

Antoine Yver, Executive Vice President and All-around Head, Oncology Research and Development, Daiichi Sankyo, said: “ Enhertu is the aboriginal antibiotic biologic conjugate to accept approval in the US for the assay of patients with metastatic belly cancer, and represents a above beforehand in managing this difficult-to-treat disease. This added adumbration in the US represents an important footfall avant-garde in our aggressive plan to beforehand the development of Enhertu beyond a ample ambit of HER2-targetable cancers.”

In a pre-specified acting assay from the DESTINY-Gastric01 trial, patients advised with Enhertu had a 41% abridgement in the accident of afterlife against patients advised with chemotherapy (based on a hazard arrangement [HR] of 0.59; 95% aplomb breach [CI] 0.39-0.88; p=0.0097) with a average OS of 12.5 months against 8.4 months.3

Confirmed ORR, adjourned by absolute axial analysis was a above ability outcome. After-effects showed a accepted ORR of 40.5% in patients advised with Enhertu (n=126) compared to 11.3% in patients advised with chemotherapy (n=62). Patients advised with Enhertu had a 7.9% complete acknowledgment bulk and a 32.5% fractional acknowledgment bulk compared to a complete acknowledgment bulk of 0% and a fractional acknowledgment bulk of 11.3% for patients advised with chemotherapy.4

Enhertu accustomed a average progression-free adaptation (PFS) of 5.6 months compared to 3.5 months with chemotherapy (HR=0.47; 95% CI 0.31-0.71).Additionally,Enhertu showed a average continuance of acknowledgment (DoR) of 11.3 months against 3.9 months with chemotherapy.4

Results from the DESTINY-Gastric01 balloon were appear in The New England Journal of Medicinein June 2020.5

The best accepted adverse reactions, including class abnormalities, of any brand (greater than or according to 20%) for patients advised with Enhertu (n=125) in the DESTINY-Gastric01 balloon were anaemia, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, nausea, decreased appetite, added aspartate aminotransferase, fatigue, added claret acrid phosphatase, added alanine aminotransferase, diarrhoea, hypokalaemia, vomiting, constipation, added claret bilirubin, agitation and alopecia. Interstitial lung ache or pneumonitis occurred in 10% of patients.4

This is the added adumbration accustomed for Enhertu in the US afterward the accelerated approval for developed patients with unresectable or metastatic HER2-positive breast blight who accept accustomed two or added above-mentioned anti-HER2-based regimens in the metastatic ambience based on the DESTINY-Breast01 trial.

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Enhertu waspreviously accepted Priority Review, Breakthrough Analysis Designation (BTD) in HER2-positive metastatic belly blight and Orphan Biologic Designation for belly blight by the FDA. Two added Phase II trials, DESTINY-Gastric02 and DESTINY-Gastric03, are underway, added evaluating assay with Enhertu in patients with HER2-positive metastatic belly cancer.

Financial considerations

Following US approval, an bulk of $115m is due from AstraZeneca to Daiichi Sankyo as a accumulated 2nd-line and 3rd-line anniversary acquittal in HER2-positive belly cancer. In AstraZeneca, the milestones paid will be capitalised as an accession to the upfront acquittal fabricated in 2019 and consecutive capitalised milestones and amortised through the accumulation and loss.

Sales of Enhertu in the US are recognised by Daiichi Sankyo. AstraZeneca letters its allotment of gross accumulation allowance from Enhertu sales in the US as accord acquirement in the Company’s banking statements. For added capacity on the banking arrangements, amuse argue the accord acceding from March 2019.

Gastric cancer

Gastric (stomach) blight is the fifth best accepted blight accepted and the third arch account of blight bloodshed with a five-year adaptation bulk of 5% for metastatic disease; there were about one actor new cases appear in 2020 and added than 768,000 deaths.6 In the US, it is estimated that 27,600 new cases of belly blight were diagnosed in 2020 and added than 11,000 bodies died from the disease. 7

Approximately one in bristles belly cancers are HER2 positive. 1 HER2 is a tyrosine kinase receptor growth-promoting protein bidding on the apparent of abounding types of tumours including breast, gastric, lung and colorectal cancers. Belly blight is usually diagnosed in the avant-garde stage, but alike back diagnosed in beforehand stages of the ache the adaptation bulk charcoal modest.2 Recommended 1st-line assay for HER2-positive avant-garde or metastatic belly blight is aggregate chemotherapy added trastuzumab, an anti-HER2 medicine, which has been apparent to beforehand adaptation outcomes back added to chemotherapy. For patients with metastatic belly blight that progresses afterward antecedent assay with a trastuzumab-based regimen, there were ahead no added accustomed HER2-targeted medicines above-mentioned to the approval of Enhertu.8

DESTINY-Gastric01

DESTINY-Gastric01 is a Phase II, open-label, multi-centre, randomised controlled balloon testing the assurance and ability of Enhertu (6.4 mg/kg) against investigator’s best of chemotherapy in a primary accomplice of patients from Japan and South Korea with HER2-positive (defined as IHC3 or IHC2 /ISH ), locally avant-garde or metastatic belly blight or GEJ adenocarcinoma who accept progressed on at atomic two or added above-mentioned regimens including trastuzumab added a fluoropyrimidine- and platinum-based chemotherapy combination. Patients (n=188) were randomised 2:1 to accept Enhertu or physician’s best of chemotherapy (paclitaxel or irinotecan monotherapy). Patients were advised with Enhertu 6.4mg/kg already every three weeks or chemotherapy.

The capital ability aftereffect measures were ORR, adjourned by absolute axial review, and OS. Added ability aftereffect measures were PFS and DoR. 4

Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzuab deruxtecan-nxki in the US) is a HER2-directed antibiotic biologic conjugate (ADC). It is the beforehand ADC in the oncology portfolio of Daiichi Sankyo and the best avant-garde programme in AstraZeneca’s ADC accurate platform.

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ADCs are targeted blight medicines that bear cytotoxic chemotherapy (‘payload’) to blight beef via a linker absorbed to a monoclonal antibiotic that binds to a specific ambition bidding on blight cells. Enhertu is comprised of a humanised anti-HER2 IgG1 monoclonal antibiotic with the aforementioned amino acerbic arrangement as trastuzumab absorbed to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approvedin the US beneath accelerated approval, and in Japan beneath the codicillary aboriginal approval system, for the assay of developed patients with unresectable or metastatic HER2-positive breast blight who accept accustomed two or added above-mentioned anti-HER2-based regimens in the metastatic ambience based on the DESTINY-Breast01 trial.In accession to the US, Enhertu (6.4mg/kg) is additionally accustomed in Japan for patients with HER2-positive unresectable avant-garde or alternate belly blight that progressed afterwards chemotherapy based on the DESTINY-Gastric01 trial.

Development programme

A absolute development programme is underway globally, with nine registrational trials evaluating the ability and assurance of Enhertu monotherapy beyond assorted HER2 cancers, including breast, belly and lung cancers. Trials in aggregate with added anticancer treatments, such as immunotherapy, are additionally underway.

In May 2020, Enhertu accustomed a BTD for the assay of patients with metastatic non-small corpuscle lung blight whose tumours accept a HER2 alteration and with ache progression on or afterwards platinum-based therapy.

Daiichi Sankyo collaboration

Daiichi Sankyo and AstraZeneca entered into a all-around accord to accordingly beforehand and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (a TROP2-directed ADC) in July 2020, except in Japan area Daiichi Sankyo maintains absolute rights. Daiichi Sankyo is amenable for accomplishment and accumulation of Enhertu and datopotamab deruxtecan.

AstraZeneca in gastrointestinal cancers

AstraZeneca has a ample development programme for the assay of gastrointestinal (GI) cancers beyond several medicines spanning a array of tumour types and stages of disease. In 2020, GI cancers collectively represented over bristles actor new blight cases arch to added than 3.5 actor deaths.6 Within this programme, the Aggregation is committed to convalescent outcomes in gastric, liver, oesophageal, pancreatic, and colorectal cancers.

The Aggregation aims to accept the abeyant of Enhertu in the two best accepted GI cancers, colorectal and belly cancers. Imfinzi (durvalumab) is actuality adjourned as both as monotherapy and in combinations including with tremelimumab beyond the two capital types of alarmist cancer, hepatocellular blight and biliary amplitude cancer, and in oesophageal and belly cancers. Lynparza (olaparib) is a first-in-class PARP inhibitor with a ample and avant-garde analytic balloon programme beyond assorted GI tumour types including pancreatic and colorectal cancers. Lynparza is developed and commercialised in accord with MSD (Merck & Co., Inc. central the US and Canada).

AstraZeneca in oncology

AstraZeneca has a abiding ancestry in oncology and offers a bound growing portfolio of new medicines that has the abeyant to transform patients’ lives and the Company’s future. With seven new medicines launched amid 2014 and 2020, and a ample pipeline of baby molecules and biologics in development, the Aggregation is committed to beforehand oncology as a key advance disciplinarian for AstraZeneca focused on lung, ovarian, breast and claret cancers.

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By harnessing the ability of six accurate platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibiotic Biologic Conjugates, Epigenetics, and Corpuscle Therapies – and by advancement the development of personalised combinations, AstraZeneca has the eyes to redefine blight assay and, one day, annihilate blight as a account of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical aggregation that focuses on the discovery, development and commercialisation of decree medicines, primarily for the assay of diseases in three analysis areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its avant-garde medicines are acclimated by millions of patients worldwide. Amuse appointment astrazeneca.com and chase the Aggregation on Twitter @AstraZeneca.

Contacts

For capacity on how to acquaintance the Investor Relations Team, amuse bang here. For Media contacts, bang here.

References

1.Curea F.G, et al. Current Targeted Therapies in HER2-Positive Belly Adenocarcinoma. Blight Biotherapy & Radiopharmaceuticals. 2017;32 (10).

2.American Blight Society. Abdomen Cancer: Aboriginal Detection, Diagnosis, and Staging. Available at: https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/survival-rates.html.

3.American Blight Society. Abdomen Cancer: Treating Abdomen Cancer. Available at: https://www.cancer.org/cancer/stomach-cancer/treating/targeted-therapies.html.

4.ENHERTU ® [fam-trastuzumab deruxtecan-nxki] US prescribing information; 2021.

5.Shitara, K et al. Trastuzumab Deruxtecan in Ahead Advised HER2-Positive Belly Cancer. N Engl J Med. 2020;382(25):2419-2430. DOI: 10.1056/NEJMoa2004413.

6.Global Blight Observatory. Blight Today. Lyon, France: International Agency for Research on Cancer. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf .

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7.American Blight Society. Abdomen Cancer: About Abdomen Cancer. Available at: https://www.cancer.org/cancer/stomach-cancer/about/key-statistics.html.

8.NCCN Guidelines ® Belly Cancer. Version 4.2019. December 20, 2019: MS-22-36.

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