AstraZeneca advances the science of cancer medicine with practice-changing data at the ASCO20 Virtual Scientific Program

Data to showcase unprecedented efficacy for Tagrisso in early-stage lung cancer and survival results for Imfinzi in small cell lung cancer

Further data will highlight the transformative potential of Enhertu across multiple HER2-driven tumours and new data for Imfinzi plus tremelimumab in liver cancer and for Lynparza in ovarian cancer

AstraZeneca will present ground-breaking new results across its broad portfolio of cancer medicines during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program, 29 to 31 May 2020. AstraZeneca will present 98 abstracts, including 19 oral presentations with one plenary and 10 late-breakers.

Presentations will showcase the Company’s leadership in the treatment of early lung cancer with a late-breaking plenary presentation of the unprecedented results from the Phase III ADAURA trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Data from the DESTINY programme will highlight the transformative potential of Enhertu (trastuzumab deruxtecan) across HER2-driven tumours, including in lung, breast, gastric and colorectal cancers.

José Baselga, Executive Vice President, Oncology R&D, said: “AstraZeneca continues to deliver results with the goal of transforming clinical practice. Our science at ASCO this year shows the potential for treatment of early-stage EGFR-mutated lung cancer, where we aim to provide the hope of cure with Tagrisso; to rewrite the rules on the treatment of patients with HER2-positive tumours with Enhertu across a range of cancer settings; and to advance our next wave of pipeline medicines focused on treating patients earlier and overcoming resistance.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “One constant throughout these uncertain times is our unwavering commitment to changing the practice of medicine for patients living with cancer. Our new oncology medicines Tagrisso, Imfinzi, Lynparza, and Enhertu are demonstrating incredible momentum at ASCO, building on their established benefits for patients by delivering powerful data in new settings and bending cancer survival curves. This year’s data at ASCO reinforce our belief that we can one day eliminate cancer as a cause of death.”

Leadership in lung cancer across stages of disease

As AstraZeneca continues to advance lung cancer research and development from early to late-stage settings, the Company will present new data for Tagrisso, Imfinzi (durvalumab), Enhertu, and potential new medicine savolitinib. Beyond ADAURA, an oral presentation of the final analysis of the Phase III CASPIAN trial confirms the sustained, clinically meaningful overall survival (OS) benefit of Imfinzi for patients with extensive-stage small cell lung cancer

(ES-SCLC). Another oral presentation reinforces the potential of Enhertu for patients with HER2-mutant NSCLC (see below). Results from a Phase II trial of savolitinib in patients with mesenchymal-epithelial transition (MET) exon 14 skipping mutations will also be presented.

Transforming treatment across HER2-driven cancers

AstraZeneca, in collaboration with Daiichi Sankyo Company, Limited (Daiichi Sankyo) will present new data from several trials highlighting the transformative potential of Enhertu, including detailed results from the Phase II DESTINY-Gastric01 trial which showed a statistically significant and clinically meaningful improvement in objective response rate and OS for patients with HER2-positive metastatic gastric cancer. Enhertu was recently granted Breakthrough Therapy Designation in the US for patients in this setting. Phase II data will also be presented for HER2-positive colorectal cancer and HER2-mutant NSCLC, two cancer settings for which there are currently no approved HER2-targeted medicines. Additionally, subgroup analyses from the Phase II DESTINY-Breast01 trial will reinforce the durable and consistent responses seen with Enhertu in HER2-positive metastatic breast cancer.

Advancing treatment in other cancer types with high unmet need

AstraZeneca will present data from several trials highlighting how the Company’s leading research is progressing treatment in other cancers where a high unmet medical need remains, including:

  • An oral presentation of results from Study 22 for the Imfinzi plus tremelimumab combination using a novel regimen in advanced liver cancer
  • Final OS results from the Phase III SOLO2 trial for Lynparza (olaparib) maintenance treatment in patients with BRCA-mutated platinum-sensitive relapsed ovarian cancer in an oral presentation. Lynparza is developed and commercialised in collaboration with MSD (MSD: known as Merck & Co., Inc. inside the US and Canada)
  • Multiple trials underscoring the impressive profile of Calquence (acalabrutinib), including data from the Phase II ACE-CL-001 trial with more than four years of follow up. The presentations represent the most mature safety and efficacy data to date with Calquence monotherapy in patients with chronic lymphocytic leukaemia

Key AstraZeneca presentations during the ASCO20 Virtual Scientific Program

Lead author Abstract title Presentation details1
Immuno-Oncology
Paz-Ares, L Durvalumab ± tremelimumab + platinum-etoposide in first-line ES-SCLC: Results from the Phase III CASPIAN study Abstract #9002Oral Abstract Session - Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Chen, Y First-line durvalumab plus platinum-etoposide in ES-SCLC (CASPIAN): Impact of brain metastases on treatment patterns and outcomes Abstract #9068Poster #261Poster Session - Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Naidoo, J Non-pneumonitis immune-mediated adverse events with durvalumab in patients with unresectable, Stage III NSCLC (PACIFIC) Abstract #9048Poster #241Poster Session - Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Kelley, RK Efficacy, tolerability, and biologic activity of a novel regimen of tremelimumab in combination with durvalumab for patients with advanced hepatocellular carcinoma (Study 22) Abstract #4508Oral Abstract Session - Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary
Oh, Do-Youn Phase II study assessing tolerability, efficacy and biomarkers for durvalumab ± tremelimumab and gemcitabine/cisplatin in chemo-naïve advanced biliary tract cancer Abstract #4520
Poster #128
Poster Session - Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary
Lim, E A Phase I, open-label multi-center study to assess the safety, pharmacokinetics, and the preliminary antitumor activity of AZD4635 both as monotherapy and in combination in patients with advanced solid malignancies: results from prostate cancer patients Abstract #5518
Poster #99
Poster Session - Genitourinary Cancer - Prostate, Testicular, and Penile
DNA damage response
Poveda, A Final overall survival results from SOLO2: a Phase III trial assessing maintenance olaparib in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA mutation Abstract #6002Oral Abstract Session - Gynecologic Cancer
Cadoo, K Olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: Phase II LIGHT study Abstract #6013
Poster #184
Poster Discussion - Gynecologic Cancer
Lee, J Cediranib in combination with olaparib in patients without a germline BRCA1/2 mutation with recurrent platinum-resistant ovarian cancer: Phase IIb CONCERTO trial Abstract #6056
Poster #227
Poster Session - Gynecologic Cancer
Poveda, A Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated platinum-sensitive relapsed ovarian cancer patients: Phase IIIb OPINION interim analysis Abstract #6057
Poster #228
Poster Session - Gynecologic Cancer
Liu, J A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer Abstract #6003Oral Abstract Session - Gynecologic Cancer
Gelmon, K Real-world clinical effectiveness and safety of olaparib monotherapy in HER2-negative gBRCA-mutated metastatic breast cancer: Phase IIIb LUCY interim analysis Abstract #1087Poster #172Poster Session - Breast Cancer - Metastatic
Tumour drivers and resistance
Herbst, R Osimertinib as adjuvant therapy in patients with Stage IB–IIIA EGFRm NSCLC after complete tumor resection: ADAURA Abstract #LBA5Plenary Session
Sunday 31 May, 1:00pm EDT
Lu, S Phase II study of savolitinib in patients with pulmonary sarcomatoid carcinoma and other types of NSCLC harboring MET exon 14 skipping mutations Abstract #9519Poster #285Poster Discussion - Lung Cancer - Non-Small Cell Metastatic
Choueiri, T SAVOIR: A Phase III study of savolitinib vs. sunitinib in patients with MET-driven papillary renal cell carcinoma Abstract #5002Oral Abstract Session - Genitourinary Cancer - Kidney and Bladder
Julia, K Concurrent osimertinib plus gefitinib for first-line treatment of EGFR-mutated NSCLC Abstract # 9507Oral Abstract Session - Lung Cancer- Non-Small Cell Metastatic
Piotrowska, Z ECOG-ACRIN 5162: A Phase II study of osimertinib 160 mg in NSCLC with EGFR exon 20 insertions Abstract #9513Poster #279Poster Discussion - Lung Cancer - Non-Small Cell Metastatic
Hamilton, E A Phase I dose escalation and expansion study of the next generation oral SERD AZD9833 in women with ER-positive, HER2-negative advanced breast cancer (SERENA-1) Abstract #1024Poster #109Poster Discussion - Breast Cancer - Metastatic
Schmid, P A Phase III trial of capivasertib and paclitaxel in first-line treatment of patients with metastatic triple-negative breast cancer (CAPItello­290) Abstract #TPS1109Poster #194Poster Session - Breast Cancer - Metastatic
Haematology
Ghia, P Acalabrutinib vs Idelalisib plus Rituximab or Bendamustine plus Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Final Results Abstract #8015Poster #348Poster Discussion - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia
Byrd, C Acalabrutinib in Treatment-Naïve Chronic Lymphocytic Leukemia: Mature Results From Phase II Study Demonstrating Durable Remissions and Long-Term Tolerability Abstract #8024Poster #357Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia
Furman, R Safety of Acalabrutinib Monotherapy in Hematologic Malignancies: Pooled Analysis From Clinical Trials Abstract #8064Poster #397Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia
Antibody drug conjugates
Smit, E Trastuzumab deruxtecan in patients with HER2-mutated metastatic NSCLC: Interim results of DESTINY-Lung01 Abstract # 9504Oral Abstract Session - Lung Cancer- Non-Small Cell Metastatic
Shitara, K Trastuzumab deruxtecan in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma: A randomized, Phase II, multicenter, open-label study (DESTINY-Gastric01) Abstract #4513Poster #121Poster Session - Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary
Siena, S A Phase II, multicenter, open-label study of trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer: DESTINY-CRC01 Abstract #4000Oral Abstract Session - Gastrointestinal Cancer - Colorectal and Anal
Modi, S Trastuzumab deruxtecan for HER2-positive metastatic breast cancer: DESTINY-Breast01 subgroup analysis Abstract #1036Poster #121Poster Session - Breast Cancer- Metastatic

1. Beginning Friday, 29 May 2020 8:00 AM EDT oral presentations, poster discussions and poster sessions will be available on demand for 180 days including video and slide presentations and discussant commentary.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca's main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 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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AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden: cancer, kardiovaskulära sjukdomar, njursjukdomar och metabola sjukdomar och sjukdomar i andningsvägarna. AstraZeneca bedriver verksamhet i över 100 länder och dess innovativa läkemedel används av miljontals patienter över hela världen. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

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