AstraZeneca Presents Promising Data from Phase III Trials Advancing Cancer Treatments at ESMO Congress

AstraZeneca Presents Promising Data from Phase III Trials Advancing Cancer Treatments at ESMO Congress

(IN BRIEF) AstraZeneca has unveiled data from four pivotal Phase III trials at the European Society for Medical Oncology (ESMO) Congress, demonstrating advances in cancer treatments across multiple types of cancers. These trials include TROPION-Lung01 and TROPION-Breast01, showcasing the significance of datopotamab deruxtecan in lung and breast cancers, as well as FLAURA2 data reinforcing Tagrisso as a therapy for EGFR-mutated lung cancer, DUO-E results highlighting the benefit of immunotherapy and PARP inhibitor combinations in endometrial cancer, and first Imfinzi data in gastric cancer from the MATTERHORN Phase III trial. The data presentations reflect AstraZeneca’s commitment to redefining cancer care and eliminating cancer as a cause of death.

(PRESS RELEASE) CAMBRIDGE, 12-Oct-2023 — /EuropaWire/ — AstraZeneca 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, 20 to 24 October 2023.

Nearly 100 abstracts will feature 19 approved and potential new medicines from AstraZeneca including two late-breaking Presidential Symposia and 26 oral presentations.

Highlights include:

• TROPION-Lung01 Phase III trial of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in patients with previously treated advanced non-small cell lung cancer (NSCLC) (Presidential Symposium, Monday 23 October).
• TROPION-Breast01 Phase III trial of datopotamab deruxtecan in patients with previously treated inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer (Presidential Symposium, Monday 23 October).
• FLAURA2 Phase III trial of Tagrisso (osimertinib) plus chemotherapy in EGFR-mutated (EGFRm) advanced NSCLC including safety and central nervous system metastases outcomes. Results were recently presented from the progression-free survival (PFS) primary analysis.
• DUO-E Phase III trial of Imfinzi (durvalumab) plus platinum-based chemotherapy followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib) as maintenance therapy in newly diagnosed advanced or recurrent endometrial cancer.
• MATTERHORN Phase III trial of Imfinzi plus neoadjuvant chemotherapy (before surgery) for patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
• DESTINY-PanTumor02 Phase II trial of AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in previously treated HER2-expressing advanced solid tumours including PFS and overall survival (OS) data from the primary analysis.
• Three bispecifics: data from several presentations will highlight the Company’s robust clinical programme of novel immuno-oncology (IO) bispecific antibodies including data for volrustomig in advanced clear cell renal cell carcinoma (MEDI5752, targeting PD-1/CTLA-4), and data for rilvegostomig (AZD2936, targeting PD-1/TIGIT) and sabestomig (AZD7789, targeting PD-1/TIM3) in lung cancer.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “At 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 programme are just the beginning for this TROP2-directed antibody drug conjugate, which we believe could replace conventional chemotherapy for many patients.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Our key data at ESMO demonstrate our commitment to redefining cancer care across a growing number of tumour types with high unmet need. Across lung, breast, gynaecologic 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.”

Datopotamab deruxtecan takes centre stage with promising data in lung and breast cancers

A 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, 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.

Another 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, datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS and a trend in improvement for OS compared to investigator’s choice of chemotherapy.

Lastly, 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 demonstrated promising clinical responses in this setting, regardless of PD-L1 expression (low and high tumours).

Imfinzi combinations enter new tumour types and continue delivering in lung and biliary tract cancers

A 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 Imfinzi alone as maintenance therapy in patients with newly diagnosed advanced or recurrent endometrial cancer. High-level results 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 Imfinzi and Lynparza as maintenance treatment.

Another 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 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.

Also 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.

A 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 tumour DNA (ctDNA) and neoadjuvant treatment responses.

Extending the benefits of Enhertu across HER2-expressing tumours

New 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 tumours, respectively, who currently have no targeted treatment options.

A 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 tumours. In July, high-level primary analysis results showed Enhertu demonstrated clinically meaningful PFS and OS, as well as provided robust and durable tumour responses across multiple HER2-expressing solid tumours in the trial. Additionally, a poster presentation will share exploratory biomarker analyses of HER2 expression and gene amplification in tissue and baseline plasma ctDNA.

A further oral presentation will feature the first report of primary results from DESTINY-PanTumor01 in patients with solid tumours that have specific HER2-activating mutations.

A 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.

Several presentations will feature new data from the DESTINY-Breast clinical programme for Enhertu, including its efficacy in patients with brain metastases.

Progressing next-wave treatments including best-in-class bispecifics

Several presentations will share data from AstraZeneca’s portfolio of novel IO bispecific antibodies, underscoring the Company’s investment in a robust clinical programme for this next wave of IO therapy.

These include:

• A mini-oral presentation of data from a Phase Ib trial of volrustomig (MEDI5752), a PD-1/CTLA-4 bispecific antibody, in the 1st-line treatment of patients with advanced clear cell renal cell carcinoma.
• Another mini-oral presentation of safety and preliminary efficacy results from the Phase I/IIa first-in-human trial of sabestomig (AZD7789), a PD-1/TIM-3 bispecific antibody, in patients with Stages IIIb-IV NSCLC resistant to previous anti-PD(L)1 therapy.
• A poster presentation of data from the ARTEMIDE-01 Phase I trial assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in patients with advanced or metastatic NSCLC.

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 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 tumour types.

Key AstraZeneca presentations during ESMO 2023

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 social media @AstraZeneca.

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SOURCE: AstraZeneca