AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, 31 May to 4 June 2024.

More than 100 abstracts will feature 25 approved and potential new medicines across the Company's diverse oncology portfolio and pipeline, including two late-breaking plenary presentations, a special late-breaking abstract session presentation and 15 oral presentations. Highlights include:

• LAURA Phase III trial of Tagrisso (osimertinib) in unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) (Plenary LBA4).
• ADRIATIC Phase III trial of Imfinzi (durvalumab) in patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following concurrent CRT (cCRT) (Plenary LBA5).
• DESTINY-Breast06 Phase III trial of Enhertu (trastuzumab deruxtecan) in patients with metastatic hormone receptor (HR)-positive HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy (LBA1000).
• First-in-human, investigator-initiated trial of C-CAR031, a novel autologous armoured Glypican 3 (GPC3) targeting chimeric antigen receptor T cell (CAR-T) therapy, in patients with liver cancer. The CAR-T is based on AZD5851, a novel cell therapy designed by AstraZeneca (Rapid Oral Abstract 4019).
• Two late-breaking presentations from the externally sponsored I-SPY2.2 Phase II trial of neoadjuvant datopotamab deruxtecan (Dato-DXd), alone and in combination with Imfinzi, in patients with breast cancer (LBA501 and LBA509).

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our plenary data at ASCO show the pioneering role of our medicines in curative-intent lung cancer treatment and highlight progress toward our continued ambition to have a medicine for more than half of all patients treated for lung cancer by 2030. The overwhelming efficacy in the LAURA trial will add to the extensive body of evidence for Tagrisso in EGFR-mutated non-small cell lung cancer, and the impressive survival data from ADRIATIC will show the potential of Imfinzi to transform outcomes in limited-stage small cell lung cancer."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Data from our antibody drug conjugates at ASCO underscore the opportunity to replace traditional chemotherapy with these medicines for many patients as we expand their use to new populations. DESTINY-Breast06 results will demonstrate the potential to treat patients across a broader spectrum of HR-positive metastatic breast cancer with Enhertu, including those with HER2-ultralow expression who have never had access to HER2-directed therapy before. We're also excited by the I-SPY2.2 efficacy and tolerability data for datopotamab deruxtecan plus Imfinzi, which will show the potential of combining antibody drug conjugates with immunotherapy in the early-stage setting."

Transforming treatment expectations across earlier-stage lung cancer settings

Several presentations will reinforce the Company's progress toward moving lung cancer treatment to earlier stages of disease. These include:

• A late-breaking plenary presentation showcasing progression-free survival (PFS) results from the LAURA Phase III trial evaluating Tagrisso in unresectable, Stage III EGFRm NSCLC after CRT. In February (https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-improved-pfs-in-stage-iii-lung-cancer.html), high-level results showed a statistically significant and highly clinically meaningful PFS benefit for Tagrisso in this setting.
• A late-breaking plenary presentation highlighting overall survival (OS) and PFS results from the ADRIATIC Phase III trial of Imfinzi in patients with LS-SCLC who had not progressed following cCRT. In April (https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-improved-os-and-pfs-in-limited-stage-sclc.html), high-level results from an interim analysis showed a statistically significant and clinically meaningful OS and PFS benefit for Imfinzi in this setting.
• An oral presentation of an analysis from the ADAURA Phase III trial of Tagrisso in the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC, assessing the potential for circulating tumour DNA-based molecular residual disease to predict disease recurrence.
• A rapid oral presentation of an exploratory analysis from the AEGEAN Phase III trial of Imfinzi-based treatment before and after surgery in patients with resectable early-stage (IIA-IIIB) NSCLC, evaluating efficacy in patients with N2 disease (cancer in the lymph nodes on the same side as the affected lung or between the lungs).
• A poster presentation of updated OS, PFS and safety results from the COAST Phase II trial of Imfinzi in combination with novel immunotherapies oleclumab, an anti-CD73 monoclonal antibody, and monalizumab, an anti-NKG2A monoclonal antibody, in unresectable, Stage III NSCLC, supporting the PACIFIC-9 Phase III trial in this patient population.

In metastatic lung cancer, the Company will present data that underscore its commitment to extending the benefits of antibody drug conjugates (ADCs) to more patients. A poster presentation will share updated safety and efficacy results, including by PD-L1 expression, from the TROPION-Lung02 Phase Ib trial of datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy as 1st-line treatment for patients with advanced NSCLC without actionable genomic alterations. These data build on previously presented (https://www.astrazeneca.com/media-centre/press-releases/2023/datopotamab-deruxtecan-improved-progression-free-survival-vs-chemotherapy-in-tropion-lung01-phase-iii-trial.html) results from the TROPION-Lung01 Phase III trial demonstrating the potential of this novel ADC in advanced disease. Datopotamab deruxtecan in combination with immunotherapies is being further explored in multiple Phase III trials in this setting, including AVANZAR, TROPION-Lung07 and TROPION-Lung08.

Redefining the breast cancer treatment landscape with ADCs across subtypes and stages of disease

A late-breaking presentation will showcase efficacy and safety outcomes from the DESTINY-Breast06 Phase III trial. In April (https://www.astrazeneca.com/media-centre/press-releases/2024/enhertu-improved-pfs-in-her2-low-and-ultralow.html), high-level results showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in PFS versus standard-of-care chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer. A clinically meaningful PFS improvement was also seen in patients with HER2-ultralow expression.

An oral presentation will spotlight data from an interim analysis of the dose-expansion phase of the DESTINY-Breast07 Phase Ib/II trial assessing Enhertu alone or in combination with pertuzumab as 1st-line treatment in HER2-positive metastatic breast cancer. These regimens are being further explored in the DESTINY-Breast09 Phase III clinical trial.

Additionally, a poster presentation will share updated OS and PFS results from the DESTINY-Breast03 Phase III trial of Enhertu versus trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane.

An oral presentation will feature patient-reported outcomes data from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan in patients with inoperable or metastatic HR-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. Previously presented (https://www.astrazeneca.com/media-centre/press-releases/2023/datopotamab-deruxtecan-significantly-extended-progression-free-survival-vs-chemotherapy-in-tropion-breast01-phase-iii-trial.html) primary results from TROPION-Breast01 showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS versus investigator's choice of chemotherapy.

Two late-breaking presentations of results from the externally sponsored I-SPY2.2 Phase II trial will highlight the rates of pathologic complete response associated with neoadjuvant datopotamab deruxtecan, alone and in combination with Imfinzi, across breast cancer subtypes.

Advancing the next wave of medicines and combination therapies to attack cancer from multiple angles

A rapid oral presentation will spotlight safety and preliminary efficacy results from an investigator-initiated trial of C-CAR031, a novel autologous armoured Glypican 3 (GPC3) targeting chimeric antigen receptor T cell (CAR-T) therapy that is being investigated for hepatocellular carcinoma. The CAR-T is based on AZD5851, a novel cell therapy designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armouring platform and is manufactured by AbelZeta Pharmaceuticals Inc. C-CAR031 is being developed in China under a co-development agreement between AbelZeta and AstraZeneca. AstraZeneca's TGFβRII dominant negative armouring is designed to resist the immuno-suppressive tumour microenvironment and enhance the potential effectiveness of CAR-Ts in solid tumours.

A rapid abstract update will feature updated efficacy data from a Phase I trial of AZD0901, a potential first-in-class ADC targeting Claudin 18.2, which has shown promise as a therapeutic target in gastric cancer. First results were presented at the ASCO Plenary Series 2023.

Additionally, a clinical science symposium presentation of the externally sponsored CAPRI Phase II trial will share efficacy and safety results for ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, plus Lynparza (olaparib) in patients with platinum-sensitive recurrent high-grade serous ovarian cancer.

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. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

Key AstraZeneca presentations during ASCO 2024

Lead Author Abstract Title Presentation details (CDT)
Lung Cancers
Ramalingam, SS Osimertinib (osi) Abstract #LBA4Plenary Session2
after definitive June 2024 2:47pm
chemoradiotherapy
(CRT) in patients
(pts) with
unresectable
stage (stg) III
epidermal growth
factor receptor
-mutated (EGFRm)
NSCLC: Primary
results of the
phase 3 LAURA
study.
Spigel, DR ADRIATIC: Abstract #LBA5Plenary Session2
durvalumab (D) as June 2024 3:21pm
consolidation
treatment (tx)
for patients
(pts) with
limited-stage
small-cell lung
cancer (LS-SCLC).
John, T Molecular Abstract #8005Oral Abstract
residual disease Session3 June 2024 9:12am
(MRD) analysis
from the ADAURA
trial of adjuvant
(adj) osimertinib
in patients (pts)
with resected
EGFR-mutated
(EGFRm) stage
IB-IIIA non-small
cell lung cancer
(NSCLC).
Heymach, J Outcomes with Abstract #8011Rapid Oral Abstract
perioperative Session2 June 2024 4:36pm
durvalumab (D) in
pts with
resectable NSCLC
and baseline N2
lymph node
involvement (N2 R
-NSCLC): An
exploratory
subgroup analysis
of AEGEAN.
Aggarwal, C Updated results Abstract #8046Poster Session3
from COAST, a June 2024 1:30pm
phase 2 study of
durvalumab (D) ±
oleclumab (O) or
monalizumab (M)
in patients (pts)
with stage III
unresectable non
-small cell lung
cancer (uNSCLC).
Levy, BP Datopotamab Abstract #8617Poster Session3
deruxtecan (Dato June 20241:30pm
-DXd) plus
pembrolizumab
(pembro) with or
without platinum
chemotherapy (Pt
-CT) as first
-line (1L)
therapy for
advanced non
-small cell lung
cancer (aNSCLC):
Subgroup analysis
from TROPION
-Lung02.
Janne, PA Trastuzumab Abstract #8543Poster Session3
deruxtecan (T June 20241:30pm
-DXd) in patients
with HER2-mutant
metastatic
non-small cell
lung cancer
(mNSCLC): Final
analysis results
of DESTINY
-Lung02.
Sun, Y Datopotamab Abstract #8548Poster Session3
deruxtecan (Dato June 20241:30pm
-DXd) in Chinese
patients (pts)
with advanced or
metastatic non
-small cell lung
cancer (NSCLC):
Results from the
phase 1/2 TROPION
-PanTumor02
study.
Lisberg, A Intracranial Abstract #8593Poster Session3
efficacy of June 20241:30pm
datopotamab
deruxtecan (Dato
-DXd) in patients
(pts) with
previously
treated
advanced/metastati
c non-small cell
lung cancer (a/m
NSCLC) with
actionable
genomic
alterations
(AGA): Results
from TROPION
-Lung05.
Sands, J Analysis of drug Abstract #8623Poster Session3
-related June 20241:30pm
interstitial lung
disease (ILD)
inpatients (pts)
treated with
datopotamab
deruxtecan (Dato
-DXd).
Breast Cancers
Curigliano, G Trastuzumab Abstract #LBA1000Oral Abstract
deruxtecan (T Session2 June 20247:30am
-DXd) vs
physician's
choice of
chemotherapy
(TPC) in patients
(pts) with
hormone receptor
-positive (HR+),
human epidermal
growth factor
receptor 2 (HER2)
-low or HER2
-ultralow
metastatic breast
cancer (mBC) with
prior endocrine
therapy (ET):
Primary results
from DESTINY
-Breast06 (DB
-06).
Pernas, S Datopotamab Abstract #1006Oral Abstract
deruxtecan (Dato Session1 June 20244:24pm
-DXd) vs
chemotherapy (CT)
in previously
treated
inoperable or
metastatic
hormone receptor
-positive, HER2
-negative
(HR+/HER2-)
breast cancer
(BC): Patient
-reported
outcomes (PROs)
from the TROPION
-Breast01 study.
Andre, F DESTINY-Breast07: Abstract #1009Oral Abstract
Dose-expansion Session1 June 20245:24pm
interim analysis
of T-DXd
monotherapy and T
-DXd + pertuzumab
in patients with
previously
untreated HER2+
mBC.
Shatsky, RA Rates of Abstract #LBA501Oral Abstract
pathologic Session3 June 20243:12pm
complete response
(pCR) after
datopotamab
deruxtecan (Dato)
plus durvalumab
(Durva) in the
neoadjuvant
setting: Results
from the I-SPY2.2
trial.
Meisel, J Rates of Abstract #LBA509 Rapid Oral
pathologic Abstract Session31 May 20242:45pm
complete response
(pCR) after
neoadjuvant
datopotamab
deruxtecan
(Dato): Results
from the I-SPY2.2
trial.
Hamilton, EP Trastuzumab Abstract #1025Poster Session2
deruxtecan (T June 20249:00am
-DXd) vs
trastuzumab
emtansine (T-DM1)
in patients (pts)
with HER2+
metastatic breast
cancer (mBC):
Updated survival
results of
DESTINY-Breast03.
Gastrointestinal
Cancers
Zhang, Q Phase I study of Abstract #4019Rapid Oral Abstract
C-CAR031, a GPC3 Session3 June 2024 10:51am      
-specific
TGFβRIIDN armored
autologous CAR-T,
in patients with
advanced
hepatocellular
carcinoma (HCC).
Xu, RH Updates on Education Session1 June
Abstract 434420: 202412:42pm
A Phase 1 Trial
of Claudin 18.2
-Specific
Antibody-Drug
Conjugate CMG901
in Patients with
Advanced
Gastric/Gastroesop
hageal Junction
Cancer
Chan, SL Safety analysis Abstract #4122Poster Session 1
by treatment June 20241:30pm
periods from
EMERALD-1: A
phase 3,
randomized,
placebo
-controlled study
of transarterial
chemoembolization
with durvalumab
with/without
bevacizumab in
participants with
embolization
-eligible
unresectable
hepatocellular
carcinoma.
Kelley, RK T cell receptor Abstract #4022Poster Session 1
and immune gene June 20241:30pm
expression
pharmacodynamics
for durvalumab
monotherapy and
in combination
with tremelimumab
or bevacizumab in
unresectable
hepatocellular
carcinoma (uHCC).
Hamilton, A ATHENA: A phase Abstract #TPS2675Poster Session1
1/2 study of June 20249:00am
AZD5851, a
chimeric antigen
receptor (CAR) T
-cell therapy
directed against
GPC3 in adult
patients with
advanced/recurrent
hepatocellular
carcinoma (HCC).
Shen, L GEMINI-Gastric: A Abstract #TPS4182Poster Session1
phase 2 study of June 20241:30pm
novel treatment
combinations in
patients with
locally advanced
unresectable or
metastatic
gastric cancers.
Zhou, J GEMINI Abstract #TPS4187Poster Session1
-Hepatobiliary: A June 20241:30pm
phase 2 study of
novel first-line
immuno-oncology
-based treatments
in patients with
advanced
hepatobiliary
cancers.
Gynaecological
Cancers
Simpkins, F Combination ATR Abstract #5510Clinical Science
and PARP Symposium1 June 20241:39pm
Inhibitor
(CAPRI): A phase
2 study of
ceralasertib plus
olaparib in
patients with
recurrent,
platinum
-sensitive
epithelial
ovarian cancer
(cohort A).
Pan-Tumour
Raufi, AG CLARITY Abstract #TPS3163Poster Session1
-PanTumor01: A June 2024 9:00am
phase 2 trial of
the claudin 18.2
-specific
antibody-drug
conjugate AZD0901
(CMG901) in
patients with
CLDN18.2
-expressing
advanced solid
tumors.
Punekar, SR An open-label, Abstract #TPS2677Poster Session1
phase 1, June 20249:00am
multicenter study
to evaluate the
safety and
preliminary anti
-tumor activity
of NT-112 in
human leukocyte
antigen
-C*08:02-positive
adult patients
with
unresectable,
advanced, and/or
metastatic solid
tumors that are
positive for the
KRAS G12D
mutation.
Spira, AI PRIMROSE: A Abstract #TPS3179ePoster Session
modular phase 1 June 20249:00am
1/2a study of
AZD3470, an MTA
-cooperative
PRMT5 inhibitor,
in patients with
MTAP deficient
advanced solid
tumors.
Perez, A Non-clinical Abstract #2560Poster Session1
evaluation of NT June 20249:00am
-175, an
autologous T cell
product
engineered to
express an HLA
-A*02:01
-restricted TCR
targeting TP53
R175H and
resistant to TGF
-b inhibition.

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 (http://www.astrazeneca.com/) and follow the Company on social media @AstraZeneca (https://www.linkedin.com/company/astrazeneca/).

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