Enhertu demonstrates transformative progression-free survival in HER2-positive metastatic breast cancer; data in lung and gastric cancers show strong efficacy across HER2-targetable tumours

Multiple trials reinforce the efficacy of Imfinzi combinations, including with novel immunotherapies, for lung cancer patients across settings

AstraZeneca will present new data across its diverse portfolio of cancer medicines at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) Congress 2021.

A total of 14 approved and potential new medicines from AstraZeneca will be featured across more than 100 abstracts at the two meetings. There will be five oral presentations including one Presidential Symposium at WCLC, hosted by the IASLC between 8 and 14 September. A total of 20 oral presentations including one Presidential Symposium will be featured at ESMO between 16 and 21 September.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Imfinzi and Tagrisso have redefined outcomes for patients with lung cancer, becoming the established standards of care around the world in certain settings. Our data at WCLC and ESMO illustrate our commitment to building on the benefits of these medicines with novel combinations to extend them to more patients. Our data will also showcase the real-world impact of these medicines in clinical practice.”

Susan Galbraith, Executive Vice President, Oncology R&D said: “The DESTINY-Breast03 data at ESMO will demonstrate the potential for Enhertu to transform the treatment of HER2-positive metastatic breast cancer with a safety profile that supports the potential for Enhertu in early-stage disease. Additionally, the data from COAST will support our aim to extend the benefit of Imfinzi in unresectable, Stage III non-small cell lung cancer by combining it with potential first-in-class immunotherapies. Also, new data on Lynparza will answer critical questions about retreatment with a PARP inhibitor in resistant disease.”

Leading in lung cancer with established standards of care and novel combinations

A Presidential Symposium will present results from the final analysis of the POSEIDON Phase III trial at WCLC showing a significant, clinically meaningful survival benefit for the combination of Imfinzi (durvalumab), tremelimumab and chemotherapy in metastatic non-small cell lung cancer (NSCLC).

A late-breaking presentation at ESMO will feature three-year overall survival (OS) data from the CASPIAN Phase III trial of Imfinzi in extensive-stage small cell lung cancer (ES-SCLC), the longest reported to date for a Phase III trial of chemotherapy and PD-1/PD-L1 immunotherapy in this disease setting. Imfinzi is the only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination with a choice of chemotherapies in ES-SCLC.

In another late-breaking presentation at ESMO, the COAST Phase II trial will highlight progression-free survival (PFS) results for novel Imfinzi combinations with potential new medicines including oleclumab, an anti-CD73 monoclonal antibody, and monalizumab, an anti-NKG2A monoclonal antibody, in unresectable, Stage III NSCLC, building on the PACIFIC Phase III trial results that established Imfinzi as the standard of care in this setting.

Data at ESMO will showcase research into combatting resistant disease, including interim results from the ORCHARD Phase II trial studying the combination of Tagrisso (osimertinib) and savolitinib, an oral, potent and highly selective MET tyrosine kinase inhibitor, in patients with advanced EGFR-mutated (EGFRm) NSCLC with MET alterations whose disease progressed on 1st-line Tagrisso.

Real-world data will provide new compelling evidence for the efficacy and safety profiles of Imfinzi and Tagrisso in NSCLC. At ESMO, PFS and tolerability data will be shared from the PACIFIC-R global observational study of patients with unresectable, Stage III NSCLC treated with Imfinzi after chemoradiation therapy. At WCLC, an interim analysis from the US cohort of a global prospective study will reinforce the efficacy of 1st-line Tagrisso in a real-world population of patients with EGFRm NSCLC.

Transforming treatment of advanced cancers with antibody drug conjugates (ADCs)

At ESMO, a Presidential Symposium will present the results from the DESTINY-Breast03 Phase III trial demonstrating the potentially transformative impact of Enhertu (trastuzumab deruxtecan) for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. DESTINY-Breast03 is the first global Phase III trial of Enhertu against an active control. In August 2021, the Independent Data Monitoring Committee recommended unblinding the trial based on a planned interim analysis showing a highly statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus trastuzumab emtansine (T-DM1).

Also at ESMO, data will include updated OS data from the DESTINY-Breast01 Phase II trial in HER2-positive metastatic breast cancer and late-breaking results from the DESTINY-Gastric02 Phase II trial in HER2-positive metastatic gastric cancer. A late-breaking presentation will feature primary analysis results from the HER2-mutant cohort of the DESTINY-Lung01 Phase II trial investigating Enhertu in patients with HER2-mutated metastatic NSCLC who have progressed following one or more systemic therapies, a setting where there are currently no approved HER2-directed treatments.

Updated data from the advanced/metastatic NSCLC cohort in the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan (Dato-DXd) will be presented at WCLC in a mini-oral presentation, and new NSCLC sub-analysis data will be shared in a late-breaking presentation at ESMO highlighting clinical activity in patients whose tumours have actionable genomic alterations. There are currently no TROP2-directed medicines approved for NSCLC, a setting where Dato-DXd has shown promising results in Phase I trials.

Changing treatment paradigms with industry-leading PARP inhibitors and next-wave DNA damage response therapies

At ESMO, late-breaking data will be presented from the OReO/ENGOT Ov-38 Phase IIIb trial testing maintenance retreatment with Lynparza (olaparib) in patients with platinum-sensitive, relapsed epithelial ovarian cancer. OReO is the first Phase III trial to evaluate retreatment with a PARP inhibitor in resistant disease. Another presentation will feature subgroup analyses and updated safety data from the POLO Phase III trial of Lynparza in germline BRCA-mutated metastatic pancreatic cancer, a disease in which no other PARP inhibitor is approved.

An oral presentation will share interim data from an externally sponsored Phase II trial with ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, testing anti-tumour activity in patients with ARID1A-deficient and -intact solid tumours.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza; with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialise Enhertu and Dato-DXd, and with HUTCHMED to develop and commercialise savolitinib. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

AstraZeneca to host virtual event on 15 September: “Spotting cancer before it has a chance: Can screening become universal?

To highlight diverse viewpoints on universal cancer screening, the Company will host a virtual event in collaboration with the European Alliance for Personalised Medicine on 15 September, 14:00 CEST. The event will bring together experts across disciplines to discuss the future of cancer screening and the barriers that persist to making screening universal. Registration for the event is open to the public.

Key AstraZeneca presentations during IASLC WCLC 2021¹

¹ 22 abstracts at IASLC WCLC 2021 will feature AstraZeneca medicines and pipeline molecules.

Key AstraZeneca presentations during ESMO Congress 2021

¹ 88 abstracts at ESMO Congress 2021 will feature AstraZeneca medicines and pipeline molecules.

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.

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