Articles from AstraZeneca

Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for subsequent surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.1,2 These data were published in the New England Journal of Medicine and presented today as a late-breaking oral presentation at the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, CA.1,2

Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation.

Results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab), administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free survival (EFS) and overall survival (OS) versus neoadjuvant chemotherapy with radical cystectomy alone in patients with or without a pathologic complete response (pCR) in muscle-invasive bladder cancer (MIBC). Patients were treated with four cycles of IMFINZI in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by eight cycles of IMFINZI monotherapy.

AstraZeneca:

AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval by the US Food and Drug Administration (FDA) was based on results from the TROPION-Breast01 Phase III trial.

AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.

Updated results from the OlympiA Phase III trial showed AstraZeneca and Merck & Co., Inc’s, known as MSD outside of the US and Canada, LYNPARZA® (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) at six years for patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.

Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

Positive results from the AMPLIFY Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with venetoclax demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia (CLL).

AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC).

AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca’s TRUQAP® (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).

AstraZeneca today pledged $3.5 million to nonprofit organizations across the US as part of Accelerate Change Together (ACT) on Health Equity, an initiative to improve access, affordability and outcomes for patients in urban, suburban and rural communities. This brings the total contributions from the program to more than $15 million to date.

AstraZeneca today announces $3.5 billion of capital investment in the United States focused on expanding the Company’s research and manufacturing footprint by the end of 2026. This includes $2 billion of new investment creating more than a thousand new, high-skilled jobs contributing to the growth of the US economy.

AstraZeneca:

Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab) demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.

AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading and diverse pipeline in hematology at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition December 7-10, 2024.

Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA ® (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.1 The trial included patients with intermittent or mild persistent asthma, including those on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy.

AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting based on positive results from the DESTINY-Breast06 Phase III trial which compared ENHERTU to chemotherapy.

AstraZeneca’s TAGRISSO® (osimertinib)​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT). TAGRISSO is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test.

High-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

FLUMIST® has been approved in the US as the only self-administered influenza vaccine. FLUMIST, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.1

AstraZeneca’s FASENRA® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).1 EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.2,3

Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment.

Positive results from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC). Patients were treated with IMFINZI in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by IMFINZI as adjuvant monotherapy.

Results from the DESTINY-Breast12 Phase IIIb/IV trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated substantial overall and intracranial clinical activity in a large cohort of patients with HER2-positive metastatic breast cancer who have brain metastases and received no more than two prior lines of therapy in the metastatic setting. Results will be presented today as a late-breaking presentation (abstract #LBA18) at the European Society for Medical Oncology (#ESMO24) and simultaneously published in Nature Medicine.

Detailed results from the TROPION-Lung01 Phase III trial showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy, in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy.

Results from an exploratory analysis of the TROPION-Lung01 Phase III trial showed TROP2 as measured by AstraZeneca’s proprietary computational pathology platform, quantitative continuous scoring (QCS), was predictive of clinical outcomes in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who were treated with datopotamab deruxtecan (Dato-DXd). In patients with TROP2-QCS biomarker positive tumors, datopotamab deruxtecan demonstrated a meaningfully greater magnitude of efficacy versus docetaxel than in the overall trial population.

AstraZeneca advances its ambition to revolutionize cancer care with new data across its diverse, industry-leading portfolio and pipeline at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer, September 7 to 10, 2024 and the European Society for Medical Oncology (ESMO) Congress, September 13 to 17, 2024.

AstraZeneca’s IMFINZI® (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with IMFINZI in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.

AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab), based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy (cCRT), has been accepted and granted Priority Review in the US.

Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia (CLL).

AstraZeneca:

Positive high-level results from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC). Patients were treated with IMFINZI in combination with neoadjuvant chemotherapy before cystectomy (surgery to remove the bladder) followed by IMFINZI as adjuvant monotherapy.

AstraZeneca’s IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel followed by IMFINZI monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).1

Positive results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and showed a favorable trend in overall survival (OS) compared to standard-of-care chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL).

AstraZeneca’s FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.1 The FDA approval was based on positive results from the pediatric T2NOW Phase III trial.2 FARXIGA was previously approved in the US in adults with T2D as an adjunct to diet and exercise to improve glycemic control.1

AstraZeneca’s supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT). If approved, TAGRISSO will be indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations.

Positive results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumors have exon 19 deletions or exon 21 (L858R) mutations, after chemoradiotherapy (CRT) compared to placebo after CRT.

Positive results from the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) ​demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to placebo for patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following standard-of-care concurrent chemoradiotherapy (cCRT).

Detailed positive results from the DESTINY-Breast06 Phase III trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer and the overall trial population (patients with HR-positive, HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining] expression) following one or more lines of endocrine therapy.

High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favoured datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.

AstraZeneca and Alexion, AstraZeneca Rare Disease, will showcase 14 studies, including real-world evidence (RWE), from their portfolio and pipeline of investigational amyloidosis therapies at the International Symposium on Amyloidosis (ISA), in Rochester, MN from May 26–30, 2024.

AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4, 2024.

Today AstraZeneca revealed its bold ambition to deliver $80 billion in Total Revenue by 2030, up from $45.8 billion in 2023. This will be achieved through significant growth in its existing oncology, biopharmaceuticals and rare disease portfolio, and by launching an expected 20 new medicines before the end of the decade. To drive sustained growth beyond 2030, the Company will continue investing in transformative new technologies and platforms that will shape the future of medicine.

The Phase IIa COURSE trial was a proof-of-concept study in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a broad range of blood eosinophil counts (BEC) and irrespective of emphysema, chronic bronchitis or smoking status.1 The primary results showed that treatment with AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab) led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant (90% CI (Confidence Interval): -6, 36], p [1-sided]=0.1042).1 The results are being presented at the American Thoracic Society (ATS) International Conference.

Positive high-level results from an interim analysis of the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus standard of care in previously untreated adult patients with mantle cell lymphoma (MCL).

AstraZeneca will showcase new clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the American Thoracic Society (ATS) International Conference, in San Diego, CA from May 17 - 22, 2024. The company will present 59 abstracts, including 12 late-breaking posters, with a focus on unmet needs in chronic obstructive pulmonary disease (COPD), severe asthma and eosinophilic granulomatosis with polyangiitis (EGPA), as well as other chronic respiratory diseases.

Positive high-level results from the DESTINY-Breast06 Phase III trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy.

AstraZeneca:

Updated exploratory results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit at three years for patients with advanced biliary tract cancer (BTC).

AstraZeneca’s FASENRA® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.1 FASENRA was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma (SEA) in patients aged 12 and older.1

AstraZeneca and Daiichi Sankyo's ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following concurrent chemoradiotherapy (cCRT) compared to placebo after cCRT.

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. The Prescription Drug User Fee Act date, the US Food and Drug Administration (FDA) action date for its regulatory decision, is during the first quarter of 2025.

AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments.

AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.* Expanding the savings programs will help make its inhalers more affordable to the most vulnerable patients living with asthma and chronic obstructive pulmonary disease (COPD), including those who are uninsured and underinsured.

AstraZeneca today announced the initiation of a Phase III trial to investigate the potential effect of triple-combination inhaled therapy BREZTRI AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate, or BGF) on severe cardiopulmonary outcomes, including death*, in people with chronic obstructive pulmonary disease (COPD) who also have elevated cardiopulmonary risk, irrespective of their exacerbation history.1

Positive results from the MANDARA Phase III trial for FASENRA® (benralizumab) in patients with EGPA were published in the New England Journal of Medicine today,1 as the first head-to-head trial of biologics in patients with EGPA,2 and the first to demonstrate that more than half of patients achieved remission with eosinophil-targeting biologic therapies.1 These findings were also presented today as a late-breaking poster at the American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting in Washington, DC, February 23-26.3

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for its regulatory decision, is during the fourth quarter of 2024.

Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) compared to placebo after CRT.

AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

AstraZeneca:

AstraZeneca is investing $300 million in a state-of-the-art facility in Rockville, MD to launch its life-saving cell therapy platforms in the US for critical cancer trials and future commercial supply. More than 150 new highly skilled jobs will be created to initially focus on manufacturing T-cell therapies to enable clinical trials to be conducted around the world. Over time, the site may expand its focus to support other disease areas.

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options.

AstraZeneca announces AIRSUPRA® (albuterol/budesonide), is now commercially available in the US by prescription. AIRSUPRA received FDA approval in January 2023 for the as-needed treatment or prevention of symptoms of asthma and to help prevent sudden severe breathing problems (asthma attacks) in people aged 18 years and older.1

Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared to TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolization.

AstraZeneca has entered into a definitive agreement to acquire Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases, furthering the AstraZeneca cell therapy ambition.

AstraZeneca and Ionis’ WAINUA™ (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN.1 WAINUA is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.2-4

AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc. (NASDAQICVX), a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform.

AstraZeneca will present new clinical and real-world data in multiple hematological conditions at the 65th American Society of Hematology (ASH) Annual Meeting andExposition, December 9 to 12, 2023 in San Diego, CA.

AstraZeneca today launches Evinova, set to be a leading provider of digital health solutions to better meet the needs of healthcare professionals, regulators and patients. With long-term backing from AstraZeneca and strategic collaborations with Parexel and Fortrea, Evinova offers globally-scaled digital products and services to the life sciences and healthcare sector.