AstraZeneca aims to transform cancer outcomes with new data across industry-leading portfolio at ESMO 2022

Results will further underscore efficacy and safety of Imfinzi, Tagrisso and Lynparza across multiple cancers with high unmet need.
Enhertu data will reinforce its transformative potential in HER2-targetable cancers.
New data for MEDI5752 will advance the science of next-generation immunotherapy.

AstraZeneca will present new data supporting its ambition to redefine cancer care at the European Society for Medical Oncology (ESMO) Congress 2022, 9 to 13 September 2022.

A total of 15 approved and potential new medicines from AstraZeneca will be featured across more than 75 abstracts in 13 tumour types.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “At ESMO this year, new evidence will demonstrate how our medicines are prolonging patient survival across several cancers. Data from the SOLO-1 and PAOLA-1 Phase III trials will reinforce the long-term survival benefits of PARP inhibition with Lynparza in advanced ovarian cancer, and new data for Imfinzi combinations in liver, biliary tract and lung cancers will show the potential to improve outcomes for patients in these areas of high unmet need.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The momentum will continue for Enhertu at ESMO with new data across tumour types, including results from the DESTINY-Lung02 Phase II trial in HER2-mutant metastatic non-small cell lung cancer which formed the basis for the recent FDA approval. Additionally, we’re excited to advance the science of CTLA-4 inhibition with new analyses presented from two Phase III trials of Imfinzi plus tremelimumab, HIMALAYA in liver cancer and POSEIDON in lung cancer, and for MEDI5752, our bispecific antibody targeting both PD-1 and CTLA-4 in lung cancer.”

Transforming outcomes across tumours over time

Mature disease-free survival (DFS) data from the ADAURA Phase III trial will be featured in a late-breaking presentation detailing two years of additional follow-up in patients with early-stage (Stage IB-IIIA) EGFR-mutated non-small cell lung cancer (NSCLC) treated with adjuvant Tagrisso (osimertinib). Tagrisso is the only targeted treatment option approved in this setting. The presentation will also report updated results for patterns of recurrence and central nervous system DFS.

A late-breaking presentation will feature landmark five-year overall survival (OS) data from the externally sponsored PAOLA-1 Phase III trial of Lynparza (olaparib) in combination with bevacizumab in 1st-line advanced ovarian cancer, including patients with homologous recombination deficiency (HRD) positive disease. This is the longest follow up for a PARP inhibitor in combination with standard of care in this setting.

In addition, seven-year OS data from the SOLO1 Phase III trial of Lynparza for 1st-line maintenance therapy in BRCA-mutated (BRCAm) advanced ovarian cancer will be presented. This is the longest follow-up for any PARP inhibitor in newly diagnosed advanced ovarian cancer.

Data will also include updated OS results at two years from the TOPAZ-1 Phase III trial of Imfinzi (durvalumab) plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line unresectable or advanced biliary tract cancer, as well as an analysis of immune-mediated adverse events. TOPAZ-1 is the first Phase III trial to show improved OS with an immunotherapy combination versus chemotherapy alone in this setting.

Extending the benefit of antibody drug conjugates (ADCs) to more patients

Several presentations will demonstrate the clinical potential of Enhertu (trastuzumab deruxtecan) treatment across HER2-targetable lung, gastric and breast cancers.

A late-breaking presentation will feature interim results from the DESTINY-Lung02 Phase II trial investigating Enhertu in patients with HER2-mutant (HER2m) metastatic NSCLC (mNSCLC) who have progressed following one or more systemic therapies. Enhertu was recently approved in the US in this setting as the first HER2-directed treatment for these patients. Detailed data will also be shared from the DESTINY-Lung01 Phase II trial, both in this setting and in patients with HER2-overexpressing mNSCLC.

Another presentation will feature updated data from the DESTINY-Gastric02 Phase II trial in HER2-positive metastatic gastric cancer, the first Enhertu trial in Western patients with gastric cancer.

Data will also include a subgroup analysis of the DESTINY-Breast03 Phase III trial of Enhertu by disease history and prior treatments in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Patient-reported outcomes from the DESTINY-Breast04 Phase III trial will also highlight quality of life data for patients treated with Enhertu in HER2-low unresectable and/or metastatic breast cancer. Enhertu was recently approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer based on this trial.

Additional posters will describe trials evaluating the TROP2-directed ADC datopotamab deruxtecan in patients with hormone-receptor positive, HER2-negative breast cancer (TROPION-Breast01 Phase III trial) and in a platform trial in combination with Tagrisso in patients with advanced NSCLC who have experienced disease progression (ORCHARD Phase II trial). There are currently no approved TROP2-directed therapies for patients in these settings.

Advancing the science of CTLA-4 inhibition

A new analysis from the positive HIMALAYA Phase III trial will show the impact of viral aetiology on outcomes in unresectable liver cancer for patients treated with a single priming dose of tremelimumab, an anti-CTLA-4 antibody, added to Imfinzi (STRIDE regimen).

In addition, a poster will describe the EMERALD-3 Phase III trial evaluating tremelimumab added to Imfinzi and transarterial chemoembolisation with or without lenvatinib in unresectable liver cancer patients eligible for embolisation.

A late-breaking presentation of the positive POSEIDON Phase III trial in mNSCLC will feature four-year OS outcomes in patients treated with a limited course of tremelimumab added to Imfinzi plus chemotherapy.

Another late-breaking presentation will share initial data for MEDI5752 plus chemotherapy in patients with treatment-naïve Stage IIIB-IV non-squamous NSCLC. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4. Bispecific antibodies are a promising approach in immuno-oncology that combines the potential benefits of two medicines into one antibody without the increased toxicity seen with administration of two separate medicines.

Reinforcing the robust benefits of PARP inhibitors across a broad range of tumour types

In addition to data from PAOLA-1 and SOLO1, an oral presentation will share updated efficacy analyses across biomarker subgroups from the PROpel Phase III trial of Lynparza plus abiraterone in patients with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) treated with the combination with or without homologous recombination repair (HRR) gene mutations. Lynparza is the first PARP inhibitor to demonstrate a significant improvement in radiographic progression-free survival in combination with abiraterone versus abiraterone alone in 1st-line mCRPC irrespective of biomarker status.

Additionally, final OS data will be presented from the MEDIOLA Phase II trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer and from the OPINION Phase IIIB trial of Lynparza maintenance monotherapy in patients with platinum-sensitive relapsed ovarian cancer without a germline BRCA1/BRCA2 mutation.

Data will also include an extended OS analysis 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.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan, and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ESMO 2022

Notes

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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