ZEGA.MU - AstraZeneca PLC

Datopotamab deruxtecan combinations showed encouraging tumor responses in patients with advanced non-small cell lung cancer in TROPION-Lung02 Phase Ib trial

WILMINGTON, Del., June 05, 2023--Updated results from the TROPION-Lung02 Phase Ib trial showed, with additional enrolment and follow-up from the initial presentation, that datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum-based chemotherapy demonstrated promising clinical activity and no new safety signals in both previously untreated or pretreated patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterat

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  Keros Therapeutics Presents Clinical Trial and Preclinical Study Results from its KER-050 Program and Preclinical Data from its ALK2 Inhibitor Program at the 28th Annual Congress of the European Hematology Association

  GlobeNewswire
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  Genmab Showcases Data From Comprehensive Epcoritamab Development Program in Patients Across B-Cell Lymphomas at European Hematology Association (EHA) Annual Meeting 2023

  Business Wire

ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated clinically meaningful and durable responses in patients across multiple HER2-expressing advanced solid tumors

WILMINGTON, Del., June 05, 2023--Positive results from an interim analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated clinically meaningful and durable responses across a broad range of HER2-expressing advanced solid tumors in previously treated patients.

ANDEXXA Phase IV Trial Stopped Early After Achieving Pre-specified Criteria on Hemostatic Efficacy Versus Usual Care

WILMINGTON, Del., June 05, 2023--ANNEXA-I, a post-marketing Phase IV trial to assess the efficacy and safety of ANDEXXA (andexanet alfa) in patients on oral FXa inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial hemorrhage, will be stopped early.1 The decision is based on achieving pre-specified stopping criteria of superior hemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, versus usual care.1,2

TAGRISSO® achieved unprecedented survival in early-stage EGFR-mutated lung cancer, with 88% of patients alive at five years in ADAURA Phase III trial

WILMINGTON, Del., June 04, 2023--Positive results from the ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.

LYNPARZA® (olaparib) and IMFINZI® (durvalumab) combination reduced risk of disease progression or death by 37% vs. chemotherapy and bevacizumab in patients with advanced ovarian cancer without tumor BRCA mutations in the DUO-O Phase III trial

WILMINGTON, Del., June 03, 2023--Positive results from a planned interim analysis of the DUO-O Phase III trial showed that treatment with a combination of LYNPARZA® (olaparib), IMFINZI® (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumor BRCA mutation

IMFINZI® (durvalumab) plus chemotherapy significantly improved pathologic complete response in gastric and gastroesophageal junction cancers in MATTERHORN Phase III trial

WILMINGTON, Del., June 02, 2023--Positive high-level results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca’s IMFINZI® (durvalumab) added to standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) neoadjuvant (before surgery) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone fo

LYNPARZA® (olaparib) plus abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer

WILMINGTON, Del., June 01, 2023--AstraZeneca and Merck & Co., Inc’s, known as MSD outside the US and Canada, LYNPARZA® (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

IMFINZI® (durvalumab) plus LYNPARZA® (olaparib) and IMFINZI alone both significantly improved progression-free survival in advanced endometrial cancer when added to chemotherapy

WILMINGTON, Del., May 26, 2023--Positive high-level results from the DUO-E Phase III trial showed IMFINZI® (durvalumab) in combination with platinum-based chemotherapy followed by either IMFINZI plus LYNPARZA® (olaparib) or IMFINZI alone as maintenance therapy both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy alone in patients with newly diagnosed advanced or recurrent endometrial cance

AstraZeneca will highlight momentum of practice-changing cancer medicines across its robust pipeline at ASCO 2023

WILMINGTON, Del., May 25, 2023--AstraZeneca advances its ambition to revolutionize cancer care with new data across its industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 2 to 6, 2023.

New AstraZeneca Data Presented at ATS 2023 Strengthen the Body of Evidence Supporting Early Intervention With BREZTRI in COPD

WILMINGTON, Del., May 23, 2023--Results from the EROS real-world retrospective study showed that initiating fixed-dose triple-combination therapy BREZTRI AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate) within 30 days of a qualifying moderate or severe exacerbation in patients with COPD (chronic obstructive pulmonary disease) is associated with a decreased risk of future exacerbations by 24% vs. delaying treatment by one to six months, and by 34% vs. delaying treatment six months to o

TAGRISSO® (osimertinib) plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial

WILMINGTON, Del., May 17, 2023--Positive high-level results from the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to TAGRISSO alone for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

FARXIGA extended in the US to reduce risk of cardiovascular death and hospitalization for heart failure to a broader range of patients

WILMINGTON, Del., May 09, 2023--AstraZeneca’s FARXIGA (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF. The approval by the Food and Drug Administration (FDA) was based on positive results from the DELIVER Phase III trial.1 FARXIGA was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF).

NEURO-TTRansform Phase III results presented at AAN showed eplontersen demonstrated consistent and sustained improvement in all measures of disease and quality of life through 66 weeks

WILMINGTON, Del., April 24, 2023--Detailed results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) showed AstraZeneca and Ionis’ eplontersen met all co-primary endpoints and secondary endpoints at 66 weeks versus an external placebo group.1

Shanghai Cellular Biopharmaceutical Group presents first data from Phase I trial evaluating a novel CAR-T in advanced liver cancer at AACR Annual Meeting

Shanghai Cellular Biopharmaceutical Group Ltd. (the Company, or Shanghai Cellular Bio), a company engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today presented data from the First-in-Human (FIH) Phase I trial evaluating C-CAR031 at the 2023 American Association for Cancer Research (AACR) Annual Meeting.

IMFINZI-based treatment before and after surgery reduced the risk of disease recurrence, progression events or death by 32% in resectable non-small cell lung cancer in the AEGEAN Phase III trial

WILMINGTON, Del., April 16, 2023--Positive results from the AEGEAN Phase III trial showed that treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery led to a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC).

New analysis of Phase II data at AACR assesses ImaginAb's investigational CD8 ImmunoPET technology's ability to predict response in immunotherapy

ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™) imaging agent and radiopharmaceutical therapies (RPT) announces a poster presentation at AACR 2023 (# 3577 / 2 Poster PET, MRI, and CT Imaging April 18, 2023) of an independent analysis undertaken by AstraZeneca (LSE/STO/Nasdaq: AZN), on data from ImaginAb's IAB-CD8-201 'iCorrelate' Phase II study. The analysis shows baseline and early on-treatment CD8 ImmunoPET/CT may be able to distinguish resp

Fusion Pharmaceuticals Announces IND Clearance for FPI-2068, a Jointly Developed Novel Targeted Alpha Therapy

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the clearance of investigational new drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA). Fusion is jointly developing FPI-2068 with AstraZeneca (LSE/STO/Nasdaq: AZN) under the companies' multi-asset collabora

AstraZeneca reinforces commitment to advancing science for patients with chronic kidney disease and hyperkalemia at NKF Spring Clinical Meeting 2023

WILMINGTON, Del., April 11, 2023--AstraZeneca will showcase five real-world evidence (RWE) studies from its industry-leading Cardiovascular, Renal and Metabolism (CVRM) portfolio, reinforcing its commitment to advancing science in chronic kidney disease (CKD) and hyperkalemia (HK), at the National Kidney Foundation (NKF) Spring Clinical Meeting April 11-15, 2023.

Eplontersen demonstrated sustained benefit in Phase III trial for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) through 66 weeks

WILMINGTON, Del., March 27, 2023--Positive high-level results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) showed eplontersen met its co-primary endpoints through 66 weeks. The results were consistent with the positive 35-week findings announced in June 2022.1

TAGRISSO® (osimertinib) demonstrated strong overall survival benefit in the ADAURA Phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

WILMINGTON, Del., March 09, 2023--Positive high-level results from the ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint, compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.

IMFINZI significantly improved event-free survival in AEGEAN Phase III trial for patients with resectable non-small cell lung cancer

WILMINGTON, Del., March 09, 2023--Positive high-level results from a planned interim analysis of the AEGEAN Phase III, placebo-controlled trial showed that treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone followed by surgery for patients with resecta

ENHERTU® (fam-trastuzumab deruxtecan-nxki) Showed Clinically Meaningful and Durable Responses Across Multiple HER2-expressing Tumor Types In DESTINY-PanTumor02 Phase II Trial

WILMINGTON, Del., March 06, 2023--Positive high-level results from an analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumors in heavily pretreated patients.

AstraZeneca and Merck present final results of key secondary overall survival endpoint from Phase III PROpel trial at ASCO GU Cancers Symposium

WILMINGTON, Del., February 16, 2023--Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed LYNPARZA® (olaparib), jointly developed and commercialized by AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada in combination with abiraterone and prednisone or prednisolone demonstrated median OS of 42.1 months versus 34.7 months for abiraterone plus placebo. This result re

TEZSPIRE® approved for self-administration in the US with a new pre-filled pen

WILMINGTON, Del., February 02, 2023--AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. TEZSPIRE is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.1