AstraZeneca advances its ambition to revolutionise cancer care with new data across its industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2 to 6 June 2023.

More than 130 abstracts will feature 22 approved and potential new medicines across the Company's diverse oncology portfolio and pipeline, including 11 oral presentations and a late-breaking plenary presentation of overall survival (OS) results from the ADAURA Phase III trial (https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-demonstrated-strong-overall-survival-benefit-in-the-adaura-phase-iii-trial.html) of Tagrisso (osimertinib) in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) lung cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our unwavering commitment to continually raising the standard of cancer care for patients with high unmet needs is evident in our data at ASCO this year. With our leading portfolio of medicines in lung cancer, our ambition is to have the right AstraZeneca medicine for more than half of all patients with this disease by 2030. We will showcase significant steps toward that goal with overall survival data from ADAURA that reinforce Tagrisso as the backbone therapy in EGFR-mutated lung cancer."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are extending the benefits of our practice-changing cancer medicines, including Tagrisso, Imfinzi and Lynparza, while also investing in new scientific platforms such as T-cell engagers and cell therapy to attack cancer from multiple angles and advance the next wave of options for patients. At ASCO, the extraordinary momentum for our antibody drug conjugate collaboration portfolio continues with data for Enhertu underscoring its potential across many HER2-expressing tumour types beyond breast, lung and gastric, and updated results for datopotamab deruxtecan that reinforce our confidence in this TROP2-directed treatment."

Improving outcomes across lung cancer settings

A late-breaking plenary presentation will showcase OS results from the ADAURA Phase III trial evaluating Tagrisso in early-stage (IB, II and IIIA) EGFR-mutated non-small cell lung cancer (NSCLC).

Several posters will describe trials-in-progress of Imfinzi (durvalumab) that further reinforce the Company's progress toward moving lung cancer treatment to earlier stages of disease. These include NeoCOAST-2 evaluating Imfinzi in multiple novel immunotherapy combinations in resectable, early-stage NSCLC; PACIFIC-4 in combination with standard of care stereotactic body radiation therapy in medically unresectable Stage I/II NSCLC; PACIFIC-8 in combination with anti-TIGIT monoclonal antibody domvanalimab in unresectable Stage III NSCLC; and PACIFIC-9 in combination with novel immunotherapies oleclumab or monalizumab in patients with unresectable Stage III NSCLC.

• An oral presentation of updated results from the TROPION-Lung02 Phase Ib dose escalation and expansion trial of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in patients with previously untreated or pretreated, advanced or metastatic NSCLC without actionable genomic alterations. TROPION-Lung02 is the first trial to show results for an antibody drug conjugate (ADC) plus an immune checkpoint inhibitor combination with or without chemotherapy in this setting.

• Interim results from the ARTEMIDE-01 Phase I trial assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in patients with advanced or metastatic NSCLC. The Company is advancing rilvegostomig into Phase III development this year.

• A trial-in-progress poster describing the EGRET Phase I trial, a first-in-human study evaluating AZD9592, an EGFR/cMET bispecific ADC, in patients with advanced solid tumours including in combination with Tagrisso in metastatic EGFRm NSCLC. This is the Company's first bispecific ADC to enter the clinic and has shown a promising efficacy and safety profile in preclinical models.

• A trial-in-progress poster describing the LATIFY Phase III trial of ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, plus Imfinzi in patients with locally advanced or metastatic NSCLC who progressed on or after anti-PD-(L)1 and platinum-based therapy. This combination has previously demonstrated promising efficacy in this setting in the ongoing HUDSON Phase II trial.

• A trial-in-progress poster detailing the TROPION-Lung04 Phase Ib dose escalation and expansion study of Dato-DXd in various immunotherapy combinations with or without carboplatin in patients with previously untreated advanced or metastatic NSCLC, including recently initiated cohorts with bispecific immunotherapies rilvegostomig and volrustomig.

Showcasing the potential of Enhertu across multiple HER2-expressing tumours

Several presentations will reinforce the potential of Enhertu (trastuzumab deruxtecan) in a broad range of HER2-expressing tumours with significant unmet need, including gynaecological, genitourinary, gastrointestinal and breast cancers.

A late-breaking oral presentation of interim results from the DESTINY-PanTumor02 Phase II trial will highlight the efficacy and safety of Enhertu in heavily pretreated patients across multiple HER2-expressing advanced solid tumours including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare cancers. In March, Enhertu met the prespecified target (https://www.astrazeneca.com/media-centre/press-releases/2023/enhertu-destiny-pantumor02-shows-positive-results.html) for objective response rate and demonstrated durable responses across multiple HER2-expressing tumour types in this trial.

Additionally, an oral presentation of primary results from the DESTINY-CRC02 Phase II trial will be presented, demonstrating the safety and efficacy of Enhertu in patients with HER2-positive advanced colorectal cancer with progression following standard-of-care treatment. This trial was initiated based on positive data for Enhertu in the DESTINY-CRC01 Phase II trial (https://www.astrazeneca.com/media-centre/press-releases/2020/enhertu-achieved-a-tumour-response-rate-of-45p-in-patients-with-her2-positive-metastatic-colorectal-cancer-in-phase-ii-destiny-crc01-trial.html).

Another oral presentation will feature a pooled benefit-risk analysis from the DESTINY-Breast01, 02 and 03 trials of Enhertu in patients with breast cancer aged 65 and older compared to those younger than 65.

Potential to transform outcomes across tumours by attacking cancer from multiple angles

A late-breaking oral presentation will feature interim progression-free survival (PFS) results from the DUO-O Phase III trial evaluating a combination of Lynparza, Imfinzi, chemotherapy and bevacizumab in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. In April, it was announced that DUO-O (https://www.astrazeneca.com/media-centre/press-releases/2023/lynparza-imfinzi-met-endpoint-in-ovarian-cancer.html) demonstrated a statistically significant and clinically meaningful improvement in PFS for this Lynparza and Imfinzi combination versus chemotherapy plus bevacizumab alone.

Data will be also shared from a post-hoc exploratory analysis of the SERENA-2 Phase II trial in patients with advanced ER-positive breast cancer who have disease recurrence or progression after endocrine therapy. The analysis will show PFS data for patients treated with next-generation selective estrogen receptor degrader (ngSERD) camizestrant versus Faslodex (fulvestrant) based on the type of ESR1 mutation at baseline, detected via circulating tumour DNA. Previously presented primary results (https://www.astrazeneca.com/media-centre/press-releases/2022/camizestrant-significantly-delayed-disease-progression-in-advanced-er-positive-breast-cancer.html) from SERENA-2 demonstrated PFS benefit with camizestrant irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors.

Data will also be shared from a matching-adjusted indirect comparison (MAIC) of the efficacy and safety of Calquence (acalabrutinib) versus zanubrutinib in relapsed or refractory chronic lymphocytic leukemia, based on data from the ASCEND and ALPINE Phase III trials.

In addition, interim Phase I results evaluating AZD0486 (TNB-486), a CD19/CD3 next-generation T-cell engager, will show the potential of targeting CD19 in heavily pretreated patients with follicular lymphoma.

Results from a Phase Ib/II dose escalation and expansion trial of the novel immunotherapy oleclumab in combination with Imfinzi and chemotherapy will also be presented in patients with metastatic pancreatic cancer, including those with high levels of CD73 expression.

A poster discussion will feature health-related quality-of-life results from the PROpel Phase III trial of Lynparza plus abiraterone in patients with metastatic castration-resistant prostate cancer.

Two presentations will focus on immune-mediated adverse events (imAEs) in the HIMALAYA Phase III trial of Imfinzi plus Imjudo (tremelimumab) in 1st-line unresectable liver cancer, including an oral presentation on outcomes by imAE occurrence and a poster on temporal patterns of imAE occurrence.

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; 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 2023

Lead Author Abstract Title Presentation details (CDT)
Tumour
drivers and
resistance
Herbst, R Overall survival Abstract #LBA3Plenary Session 4 June
analysis from the 20232:17pm
ADAURA trial of
adjuvant
osimertinib in
patients with
resected EGFR
mutated- (EGFRm)
stage IB-IIIA non
-small cell lung
cancer (NSCLC).
Oliveira, M Clinical activity Abstract #1066Poster Session Breast
of camizestrant, Cancer-Metastatic 4 June 20238:00am
a next-generation
SERD, versus
fulvestrant in
patients with a
detectable ESR1
mutation:
Exploratory
analysis of the
SERENA-2 Phase 2
trial.
Antibody
drug
conjugates
Meric Efficacy and Abstract #LBA3000Oral Abstract Session
-Bernstam, safety of Developmental Therapeutics-Molecularly
F trastuzumab Targeted Agents and Tumor Biology5 June
deruxtecan (T 20238:00am
-DXd) in patients
(pts) with HER2
-expressing solid
tumors: DESTINY
-PanTumor02 (DP
-02) interim
results.
Raghav, K Trastuzumab Abstract #3501Oral Abstract Session
deruxtecan (T Gastrointestinal Cancer-Colorectal and Anal4
-DXd) in patients June 20238:12am
(pts) with HER2
-overexpressing/am
plified (HER2+)
metastatic
colorectal cancer
(mCRC): Primary
results from the
multicenter,
randomized, Phase
2 DESTINY-CRC02
study.
Krop, I An age-specific Abstract #1006Oral Abstract Session Breast
pooled analysis Cancer-Metastatic 5 June 20231:30pm
of trastuzumab
deruxtecan
(T-DXd) in
patients (pts)
with HER2
-positive (HER2+)
metastatic breast
cancer (mBC) from
DESTINY-Breast01,
-02, and -03.
Goto, Y TROPION-Lung02: Abstract #9004 Oral Abstract Session Lung
Datopotamab Cancer-Non-Small Cell Metastatic6 June
deruxtecan (Dato 202310:57am
-DXd) plus
pembrolizumab
(pembro) with or
without platinum
chemotherapy (Pt
-CT) in advanced
non-small cell
lung cancer
(aNSCLC).
Aggarwal, C EGRET: A first-in Abstract #TPS3156Poster Session Developmental
-human study of Therapeutics-Molecularly Targeted Agents and
the novel Tumor Biology3 June 20238:00am
antibody-drug
conjugate (ADC)
AZD9592 as
monotherapy or
combined with
other anticancer
agents in
patients (pts)
with advanced
solid tumors.
Borghaei, H TROPION-Lung04: Abstract#TPS3158Poster Session Developmental
Phase 1b, Therapeutics-Molecularly Targeted Agents and
multicenter study Tumor Biology3 June 20238:00am
of datopotamab
deruxtecan (Dato
-DXd) in
combination with
immunotherapy ±
carboplatin in
advanced/metastati
c non-small cell
lung cancer
(mNSCLC).
DNA damage
response
Harter, P Durvalumab with Abstract #LBA5506Oral Abstract Session
paclitaxel/carbopl Gynecologic Cancer3 June 20235:12pm
atin (PC) and
bevacizumab
(bev), followed
by maintenance
durvalumab, bev,
and olaparib in
patients (pts)
with newly
diagnosed
advanced ovarian
cancer (AOC)
without a tumor
BRCA1/2 mutation
(non-tBRCAm):
Results from the
randomized,
placebo (pbo)
-controlled Phase
III DUO-O trial.
Armstrong, Health-related Abstract #5012Poster Discussion Genitourinary
A quality of life Cancer-Prostate, Testicular, and Penile
(HRQoL) and pain Session 3 June 20231:27pm
outcomes for
patients (pts)
with metastatic
castration
-resistant
prostate cancer
(mCRPC) who
received
abiraterone (abi)
and olaparib
(ola) versus (vs)
abi and placebo
(pbo) in the
Phase III PROpel
trial.
Immuno
-Oncology
Hübner, H RNA expression Abstract #1011Oral Abstract SessionClinical
levels from Science Symposium:  Harnessing the Breast
peripheral immune Cancer Immune Response3 June 2023 1:51pm
cells, a
minimally
invasive liquid
biopsy source to
predict response
to therapy,
survival and
immune-related
adverse events in
patients with
triple negative
breast cancer
enrolled in the
GeparNuevo trial.
Lau, G Outcomes by Abstract #4004Oral Abstract Session
occurrence of Gastrointestinal Cancer-Gastroesophageal,
immune-mediated Pancreatic, and Hepatobiliary 2 June
adverse events 20233:57pm
(imAEs) with
tremelimumab (T)
plus durvalumab
(D) in the Phase
3 HIMALAYA study
in unresectable
hepatocellular
carcinoma (uHCC).
Besse, B LATIFY: Phase 3 Abstract #TPS9161Poster Session Lung
study of Cancer-Non-Small Cell Metastatic4 June
ceralasertib + 20238:00am (CDT)
durvalumab vs
docetaxel in
patients with
locally advanced
or metastatic non
-small-cell lung
cancer that
progressed on or
after anti-PD
-(L)1 and
platinum-based
therapy.
Rohrberg, K Safety, Abstract #9050Poster Session Lung Cancer-Non
pharmacokinetics -Small Cell Metastatic4 June 20238:00am
(PK),
pharmacodynamics
(PD) and
preliminary
efficacy of
AZD2936, a
bispecific
antibody
targeting PD-1
and TIGIT, in
checkpoint
inhibitor (CPI)
-experienced
advanced/metastati
c non-small-cell
lung cancer
(NSCLC): First
report of
ARTEMIDE-01.
Guisier, F NeoCOAST-2: A Abstract #TPS8604Poster Session Lung
Phase 2 study of Cancer-Non-Small Cell Local Regional/Small
neoadjuvant Cell/Other Thoracic Cancers4 June 20238:00am
durvalumab plus
novel
immunotherapies
(IO) and
chemotherapy (CT)
or MEDI5752
(volrustomig)
plus CT, followed
by surgery and
adjuvant
durvalumab plus
novel IO or
volrustomig alone
in patients with
resectable non
-small-cell lung
cancer (NSCLC).
Robinson, C Phase 3 study of Abstract #TPS8607Poster Session Lung
durvalumab with Cancer-Non-Small Cell Local-Regional/Small
SBRT for Cell/Other Thoracic Cancers4 June 20238:00am
unresected stage
I/II, lymph-node
negative NSCLC
(PACIFIC
-4/RTOG3515).
Özgüroğlu, Phase 3 trial of Abstract #TPS8609Poster Session Lung
M durvalumab Cancer-Non-Small Cell Local-Regional/Small
combined with Cell/Other Thoracic Cancers4 June 20238:00am
domvanalimab
following
concurrent
chemoradiotherapy
(cCRT) in
patients with
unresectable
stage III NSCLC
(PACIFIC-8).
Barlesi, F Phase 3 study of Abstract #TPS8610Poster Session Lung
durvalumab Cancer-Non-Small Cell Local-Regional/Small
combined with Cell/Other Thoracic Cancers4 June 20238:00am
oleclumab or
monalizumab in
patients with
unresectable
stage III NSCLC
(PACIFIC-9).
Ganti, A The prognostic Abstract #8516Poster Discussion Session Lung
value of patient Cancer-Non-Small Cell Local-Regional/Small
reported outcomes Cell/Other Thoracic Cancers4 June 202311:45am
(PROs) and
clinical/demograph
ic variables in
the CASPIAN
study.
Lau, G Temporal patterns Abstract #4073Poster Session Gastrointestinal
of immune Cancer-Gastroesophageal, Pancreatic, and
-mediated adverse Hepatobiliary5 June 20238:00am
events (imAEs)
with tremelimumab
(T) plus
durvalumab (D) in
the Phase 3
HIMALAYA study in
unresectable
hepatocellular
carcinoma (uHCC).
Coveler, A Safety and Abstract #4136Poster Session Gastrointestinal
clinical activity Cancer-Gastroesophageal, Pancreatic, and
of oleclumab (O) Hepatobiliary5 June 20238:00am
± durvalumab (D)
+ chemotherapy
(CT) in patients
(pts) with
metastatic
pancreatic ductal
adenocarcinoma
(mPDAC): A Phase
1b/2 randomized
study.
Haematology
Kittai, A A matching Abstract #7540Poster Session Hematologic
-adjusted Malignancies-Lymphoma and Chronic Lymphocytic
indirect Leukemia5 June 20238:00am
comparison (MAIC)
of the efficacy
and safety of
acalabrutinib
(acala) versus
zanubrutinib
(zanu) in
relapsed or
refractory
chronic
lymphocytic
leukemia (RR
CLL).
Nair, R High complete Abstract #7524Poster Session Hematologic
response rate Malignancies-Lymphoma and Chronic Lymphocytic
with TNB-486 in Leukemia5 June 20238:00am
relapsed/refractor
y follicular
lymphoma: Interim
results an
ongoing Phase 1
study.

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 Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

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