August 24, 2022: “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
| Lead author | Abstract title | Presentation details |
|---|---|---|
| Antibody drug conjugates | ||
| Goto, K | Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC): Interim Results From the Phase 2 DESTINY-Lung02 Trial | Presentation #LBA55Mini Oral Session11 September 202210:15am (CEST) |
| Ueno, NT | Patient-Reported Outcomes (PROs) From DESTINY-Breast04, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Treatment of Physician’s Choice (TPC) in Patients (pts) With HER2-Low Metastatic Breast Cancer (MBC) | Presentation #217OProffered Paper Session11 September 20229:30am (CEST) |
| Ku, GY | Updated Analysis of DESTINY-Gastric02: a Phase 2 Single-Arm Trial of Trastuzumab Deruxtecan (T-DXd) in Western Patients (Pts) With HER2-Positive (HER2+) Unresectable/Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer Who Progressed on or After Trastuzumab-Containing Regimen | Presentation #1205MOMini Oral Session10 September 20223:45pm (CEST) |
| Cortés, J | Subgroup Analysis by Disease History and Prior Treatments of Patients (pts) With HER2-Positive (HER2+) Metastatic Breast Cancer (MBC) From DESTINY-Breast03, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Trastuzumab Emtansine (T-DM1) | Presentation #236Pe-Poster10 September 2022 |
| Li, BT | Phase 2 Trial of Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutated (HER2m) Metastatic Non-Small Cell Lung Cancer (NSCLC): Registrational Data From DESTINY-Lung01 | Presentation #976Pe-Poster12 September 2022 |
| Bardia, A | Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators’ choice of chemotherapy (ICC) in previously-treated, inoperable or metastatic hormone-receptor (HR) positive, HER2-negative (HR+/HER2–) breast cancer: TROPION-Breast01 | Presentation #274TiPTrial in Progress10 September 2022 |
| De Langen, J | ORCHARD platform study: osimertinib + datopotamab deruxtecan (Dato-DXd) cohort in patients (pts) with advanced NSCLC (aNSCLC) who have progressed on first-line (1L) osimertinib | Presentation #1188TiPTrial in Progress12 September 2022 |
| Immuno-oncology | ||
| Johnson, ML. | Durvalumab (D) ± tremelimumab (T) + chemotherapy (CT) in 1L metastatic (m) NSCLC: overall survival (OS) update from POSEIDON after median follow-up (mFU) of approximately 4 years (y) | Presentation #LBA59Mini Oral Session11 September 202211:05am (CEST) |
| Ahn, MJ | MEDI5752 or pembrolizumab (P) plus carboplatin/pemetrexed (CP) in treatment-naïve (1L) non-small cell lung cancer (NSCLC): a Phase 1b/2 trial | Presentation #LBA56Mini Oral Session11 September 202210:20am (CEST) |
| Spicer, J | Platform study of neoadjuvant durvalumab (D) alone or combined with novel agents in patients (pts) with resectable, early-stage non-small-cell lung cancer (NSCLC): pharmacodynamic correlates and circulating tumor DNA (ctDNA) dynamics in the NeoCOAST study | Presentation #929MOMini Oral Session12 September 20223:15pm (CEST) |
| Oh, DY | Updated overall survival (OS) from the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in patients (pts) with advanced biliary tract cancer (BTC) | Presentation #56Pe-Poster12 September 2022 |
| Antonuzzo, L | Immune-mediated adverse event (imAE) incidence, timing and association with efficacy in the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in advanced biliary tract cancer (BTC) | Presentation #57Pe-Poster12 September 2022 |
| Chan, LS | Impact of viral aetiology in the Phase 3 HIMALAYA study of tremelimumab (T) plus durvalumab (D) in unresectable hepatocellular carcinoma (uHCC) | Presentation #714Pe-Poster12 September 2022 |
| Özgüroğlu, M | Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8) | Presentation #971TiPTrial in Progress10 September 2022 |
| Abou-Alfa, GK | A randomised Phase 3 study of tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC): EMERALD-3 | Presentation #727TiPTrial in Progress12 September 2022 |
| DNA damage response | ||
| Ray-Coquard, IL | Final overall survival (OS) results from the Phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) | Presentation #LBA29Proffered Paper Session9 September 20222:00pm (CEST) |
| DiSilvestro, P | Overall survival (OS) at 7-year (y) follow-up (f/u) in patients (pts) with newly diagnosed advanced ovarian cancer (OC) and a BRCA mutation (BRCAm) who received maintenance olaparib in the SOLO1/GOG-3004 trial | Presentation #517OProffered Paper Session9 September 20222:10pm (CEST) |
| Guo, C | A Phase (Ph) I/II trial of the CXCR2 antagonist AZD5069 in combination with enzalutamide (ENZA) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC) | Presentation #454OProffered Paper Session10 September 202211:15am (CEST) |
| Saad, F | Biomarker analysis and updated results from the Phase III PROpel trial of abiraterone (abi) and olaparib (ola) vs abi and placebo (pbo) as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) | Presentation #1357OProffered Paper Session11 September 20229:30am (CEST) |
| Banerjee, S | Phase II study of olaparib plus durvalumab with or without bevacizumab (MEDIOLA): final analysis of overall survival in patients with non-germline BRCA-mutated platinum-sensitive relapsed ovarian cancer | Presentation #529MOMini Oral Session11 September 20225:00pm (CEST) |
| Poveda Velasco, AM | Maintenance olaparib monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) without a germline BRCA1/BRCA2 mutation (non-gBRCAm): final overall survival (OS) results from the OPINION trial | Presentation #531Pe-Poster11 September 2022 |
| Hammel, P | Extended overall survival results from the POLO study of active maintenance olaparib in patients with metastatic pancreatic cancer and a germline BRCA mutation | Presentation #1298Pe-Poster12 September 2022 |
| Tumour drivers and resistance | ||
| Tsuboi, M | Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC): updated results from ADAURA | Presentation #LBA47Proffered Paper Session11 September 20228:30am (CEST) |
| Piotrowska, Z | ELIOS: A multicentre, molecular profiling study of patients (pts) with epidermal growth factor receptor-mutated (EGFRm) advanced NSCLC treated with first-line (1L) osimertinib | Presentation #LBA53Proffered Paper Session11 September 20223:05pm (CEST) |
| Nakamura, A | Final results and biomarker analysis of a randomized phase II study of osimertinib plus bevacizumab versus osimertinib monotherapy for untreated patients with non-squamous non-small-cell lung cancer harboring EGFR mutations; WJOG9717L study | Presentation #982Pe-Poster12 September 2022 |
