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AstraZeneca advances scientific leadership across multiple cancers with first data from four pivotal Phase III trials at ESMO<\/b><\/p>\n
Two highly anticipated Presidential Symposia for TROPION-Lung01 and TROPION-Breast01 will unveil the significance of datopotamab deruxtecan in lung and breast cancers<\/i><\/b><\/p>\n
FLAURA2 data reinforce TAGRISSO\u00ae<\/sup> (osimertinib) as the backbone therapy in EGFR-mutated lung cancer and underscore its added benefit of treating brain metastases<\/i><\/b><\/p>\n DUO-E results for IMFINZI\u00ae<\/sup> (durvalumab) plus LYNPARZA\u00ae<\/sup> (olaparib) will show the benefit of immunotherapy and PARP inhibitor combinations in endometrial cancer for the first time<\/i><\/b><\/p>\n First IMFINZI data in gastric cancer from MATTERHORN Phase III trial will highlight the potential of immunotherapy combinations in earlier settings and growing leadership in gastrointestinal cancers<\/i><\/b><\/p>\n WILMINGTON, Del.–(BUSINESS WIRE<\/a>)– \nNearly 100 abstracts will feature 19 approved and potential new medicines from AstraZeneca including two late-breaking Presidential Symposia and 26 oral presentations. Highlights include:<\/p>\n \nSusan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: \u201cAt ESMO, we are building on the potential of our antibody drug conjugate portfolio with results from the TROPION-Lung01 and TROPION-Breast01 Phase III trials demonstrating the promise of datopotamab deruxtecan for patients across multiple cancer types in two back-to-back Presidential Symposia. These first pivotal data from our robust clinical program are just the beginning for this TROP2-directed antibody drug conjugate, which we believe could replace conventional chemotherapy for many patients.\u201d<\/p>\n \nDave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: \u201cOur key data at ESMO demonstrate our commitment to redefining cancer care across a growing number of tumor types with high unmet need. Across lung, breast, gynecologic and gastrointestinal cancers, the first data will be presented from four different pivotal trials which will raise the bar for patients with multiple medicines from our industry-leading portfolio and highlight the power of novel combinations.\u201d<\/p>\n Datopotamab deruxtecan takes center stage with promising data in lung and breast cancers<\/b><\/p>\n \nA Presidential Symposium will highlight PFS data from the TROPION-Lung01 Phase III trial evaluating datopotamab deruxtecan in patients with previously treated advanced NSCLC. In July<\/a>, datopotamab deruxtecan became the first antibody drug conjugate to demonstrate a statistically significant improvement in PFS and a trend in improvement for OS compared to docetaxel, the current standard-of-care chemotherapy. Additionally, a mini-oral presentation will feature initial results from the TROPION-Lung05 Phase II trial evaluating datopotamab deruxtecan in patients with heavily pretreated advanced NSCLC with actionable genomic mutations (AGA). There are currently no TROP2-directed antibody drug conjugates approved for the treatment of patients with lung cancer.<\/p>\n \nAnother Presidential Symposium will showcase data from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. In September<\/a>, datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS and a trend in improvement for OS compared to investigator\u2019s choice of chemotherapy.<\/p>\n \nLastly, a mini-oral presentation will highlight updated safety and efficacy results from the BEGONIA Phase Ib\/II trial of datopotamab deruxtecan plus IMFINZI in patients with previously untreated unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC), including duration of response. Early data from the trial presented previously<\/a> demonstrated promising clinical responses in this setting, regardless of PD-L1 expression (low and high tumors).<\/p>\n IMFINZI combinations enter new tumor types and continue delivering in lung and biliary tract cancers<\/b><\/p>\n \nA late-breaking oral presentation will feature PFS data from the DUO-E Phase III trial evaluating treatment with IMFINZI and chemotherapy followed by either IMFINZI plus LYNPARZA or IMFINZIalone as maintenance therapy in patients with newly diagnosed advanced or recurrent endometrial cancer. High-level results<\/a> recently announced showed both regimens demonstrated a statistically significant and clinically meaningful improvement in PFS compared to standard-of-care chemotherapy alone, with greater clinical benefit observed with the combination of IMFINZIand LYNPARZAas maintenance treatment.<\/p>\n \nAnother late-breaking oral presentation will highlight pathologic complete response (pCR) data from the MATTERHORN Phase III trial of IMFINZI added to standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) neoadjuvant chemotherapy for patients with resectable, early-stage and locally advanced gastric and GEJ cancers versus neoadjuvant therapy alone. High-level interim results<\/a> demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pCR. This is the first global Phase III trial of an immunotherapy and FLOT chemotherapy combination to demonstrate clinical benefit in this setting. The trial is continuing to assess the primary endpoint of event-free survival.<\/p>\n \nAlso in gastrointestinal cancers, two poster presentations of new data from the TOPAZ-1 Phase III trial will further reinforce the benefit of IMFINZI plus chemotherapy as a 1st-line standard-of-care treatment for advanced biliary tract cancer. Results will be shared from an exploratory analysis of an extended cohort of TOPAZ-1 patients enrolled in China. Additionally, results will be shared from an exploratory analysis assessing the impact of prognostic or predictive factors of OS in the trial.<\/p>\n \nA late-breaking mini-oral presentation in lung cancer will report exploratory analyses from the AEGEAN Phase III trial of IMFINZI-based treatment before and after surgery in patients with resectable NSCLC, evaluating potential associations between circulating tumor DNA (ctDNA) and neoadjuvant treatment responses.<\/p>\n Extending the benefits of ENHERTUacross HER2-expressing tumors<\/b><\/p>\n \nNew data from the DESTINY-PanTumor02 and DESTINY-PanTumor01 Phase II trials will underscore the potential of ENHERTU for previously treated patients with HER2-expressing or HER2-mutated advanced solid tumors, respectively, who currently have no targeted treatment options.<\/p>\n \nA late-breaking mini-oral presentation of primary results from DESTINY-PanTumor02 will highlight efficacy and safety outcomes for ENHERTU in patients with HER2-expressing solid tumors. In July<\/a>, high-level primary analysis results showed ENHERTU demonstrated clinically meaningful PFS and OS, as well as provided robust and durable tumor responses across multiple HER2-expressing solid tumors in the trial. Additionally, a poster presentation will share exploratory biomarker analyses of HER2 expression and gene amplification in tissue and baseline plasma ctDNA.<\/p>\n \nA further oral presentation will feature the first report of primary results from DESTINY-PanTumor01 in patients with solid tumors that have specific HER2-activating mutations.<\/p>\n \nA mini-oral presentation will feature post-hoc pooled efficacy and safety analyses of the DESTINY-Lung01 and DESTINY-Lung02 Phase II trials of ENHERTU in patients with HER2-mutated metastatic NSCLC with and without brain metastases.<\/p>\n \nSeveral presentations will feature new data from the DESTINY-Breast clinical program for ENHERTU, including its efficacy in patients with brain metastases.<\/p>\n Progressing next-wave treatments including best-in-class bispecifics<\/b><\/p>\n \nSeveral presentations will share data from AstraZeneca\u2019s portfolio of novel IO bispecific antibodies, underscoring the Company\u2019s investment in a robust clinical program for this next wave of IO therapy. These include:<\/p>\n \nCollaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialize ENHERTUand datopotamab deruxtecan, and with Merck & Co., Inc., known as MSD outside the US and Canada, to develop and commercialize LYNPARZA both as a monotherapy and in combination with other potential medicines. Independently, the companies are developing LYNPARZA in combination with their respective PD-L1 and PD-1 medicines, IMFINZI and pembrolizumab, in a number of tumor types.<\/p>\n Key AstraZeneca presentations during ESMO 2023<\/b><\/p>\n
\nAstraZeneca advances its ambition to eliminate cancer as a cause of death with new data across its robust portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress, October 20-24, 2023.<\/p>\n\n
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