AstraZeneca will present new data in liver, biliary tract and prostate cancers illustrating its ambition to revolutionise cancer care at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) and the 2022 ASCO Genitourinary Cancers Symposium (ASCO GU).

A total of 35 abstracts from AstraZeneca will be featured across the two meetings. There will be two oral presentations at ASCO GI taking place 20 to 22 January, and an additional two oral presentations at ASCO GU taking place 17 to 19 February.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "There is an urgent need for new effective treatment options to delay disease recurrence and improve survival for patients with advanced liver, biliary tract and prostate cancers. Our data for Imfinzi and Lynparza at these two meetings will illustrate how AstraZeneca is extending the benefits of our medicines into new areas where progress for patients has been limited."

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: "Our data will demonstrate the potential of our medicines to transform patient outcomes in liver, biliary tract and prostate cancers. Results from HIMALAYA and TOPAZ-1 will underscore our commitment to improving long-term survival for patients with liver and biliary tract cancers, and data from PROpel will raise the bar in treating 1st-line metastatic castration-resistant prostate cancer."

Aiming to transform treatment of liver and biliary tract cancers with immunotherapy combinations at ASCO GI

A late-breaking presentation will feature results from the HIMALAYA Phase III trial showing a statistically significant and clinically meaningful overall survival (OS) benefit with a single priming dose of tremelimumab added to Imfinzi (durvalumab) in 1st-line unresectable liver cancer.

This trial used a novel dose and schedule called the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen. HIMALAYA is the first Phase III trial to show that a dual immunotherapy regimen has improved OS in this setting.

A second late-breaking presentation will highlight results from the TOPAZ-1 Phase III trial for Imfinzi plus chemotherapy in advanced biliary tract cancer, which was unblinded early at an interim analysis in October 2021 due to clear evidence of efficacy.

The combination demonstrated a statistically significant and clinically meaningful OS benefit versus chemotherapy alone in 1st-line advanced biliary tract cancer, making it the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomised trial in this setting.

Also at the meeting, the first data from Imfinzi plus bevacizumab in the Study 22 Phase II trial will provide the efficacy and safety profile of this combination in unresectable liver cancer. This regimen is being tested in the EMERALD-1 Phase III trial of transarterial chemoembolisation in combination with Imfinzi alone and with bevacizumab in patients with locoregional liver cancer, as well as in the EMERALD-2 Phase III trial with liver cancer patients who are at high risk of recurrence after curative hepatic resection or ablation.

Challenging the status quo in prostate cancer with an industry-leading PARP inhibitor at ASCO GU

A late-breaking presentation will showcase the results from the PROpel Phase III trial of Lynparza (olaparib) plus abiraterone, which showed the combination significantly delayed disease progression in 1st-line metastatic castration-resistant prostate cancer (mCRPC) regardless of biomarker status. Lynparza is the first PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this setting.

Additionally, an oral presentation will feature the results of the BAYOU Phase II trial evaluating the combination of Lynparza and Imfinzi in unresectable, Stage IV bladder cancer. Data will show comparable efficacy of Imfinzi monotherapy to that of other immune checkpoint monotherapy data in similar trial populations and will suggest additional research into a potential role for PARP inhibition in subsets of patients with specific gene mutations.

Harnessing the potential of antibody drug conjugates across HER2-targetable cancers

At ASCO GI, data will include an encore presentation of the OS results of the DESTINY-Gastric01 Phase II trial of Enhertu (trastuzumab deruxtecan) in HER2-positive metastatic gastric and gastro-oesophageal junction adenocarcinoma (GEJA), and initial results from the DESTINY-Gastric03 Phase Ib/II trial in HER2-positive gastric cancer and GEJA.

In January 2021, Enhertu became the first HER2-directed medicine approved for patients with gastric cancer in a decade.

Additional Enhertu data at ASCO GI will include encore results from the DESTINY-CRC01 Phase II trial showing clinically meaningful activity in HER2-positive unresectable and/or metastatic colorectal cancer. The overall safety and tolerability profile of Enhertu in DESTINY-CRC01 was consistent with that seen in previously reported Enhertu trials. There are currently no medicines approved to specifically treat HER2-positive colorectal cancer.

At ASCO GU, results will be shared from the primary analysis of a Phase Ib trial of Enhertu in combination with nivolumab in HER2-expressing bladder cancer.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza, and with Daiichi Sankyo Company Limited to develop and commercialise Enhertu.

Key AstraZeneca presentations during ASCO GI 2022

Lead Abstract title Presentation details
author
Immuno
-Oncology
Alfa-Abou, Phase 3 Abstract Presentation 3Oral Abstract Session B:
GK randomized, open Cancers of the Pancreas, Small Bowel, and
-label, Hepatobiliary Tract21 January 202217:07 - 17:17
multicenter study ET22:07 - 22:17 GMT
of tremelimumab
(T) and
durvalumab (D) as
first-line
therapy in
patients (pts)
with unresectable
hepatocellular
carcinoma (uHCC):
HIMALAYA.
Oh, D-Y A phase 3 Abstract Presentation 2Oral Abstract Session B:
randomized, Cancers of the Pancreas, Small Bowel, and
double-blind, Hepatobiliary Tract21 January 202216:45 - 16:55
placebo ET21:45 - 22:55 GMT
-controlled study
of durvalumab in
combination with
gemcitabine plus
cisplatin
(GemCis) in
patients (pts)
with advanced
biliary tract
cancer (BTC):
TOPAZ-1.
Wang, L A phase 3 Trials in Progress Poster Session A: Cancers of
randomized, the Esophagus and Stomach and Other GI Cancers
double-blind,
placebo
-controlled,
multicenter,
global study of
durvalumab with
and after
chemoradiotherapy
in patients with
locally advanced,
unresectable
esophageal
squamous cell
carcinoma:
KUNLUN.
Antibody
drug
conjugates
Yamaguchi, Trastuzumab Rapid Abstract Session A: Cancers of the
K deruxtecan (T Esophagus and Stomach
-DXd; DS-8201) in
patients with
HER2-positive
advanced gastric
or
gastroesophageal
junction (GEJ)
adenocarcinoma:
Final overall
survival (OS)
results from a
randomized,
multicenter, open
-label, phase 2
study (DESTINY
-Gastric01).
Janjigian, Dose-escalation Poster Session A: Cancers of the Esophagus and
YY and dose Stomach and Other GI Cancers
-expansion study
of trastuzumab
deruxtecan (T
-DXd) monotherapy
and combinations
in patients (pts)
with
advanced/metastati
c HER2+ gastric
cancer
(GC)/gastroesophag
eal junction
adenocarcinoma
(GEJA): DESTINY
-Gastric03.
Meric A phase 2, Trials in Progress Poster Session B: Cancers of
-Bernstam, multicenter, open the Pancreas, Small Bowel, and Hepatobiliary
F -label study Tract
evaluating
trastuzumab
deruxtecan (T
-DXd) for the
treatment of
select human
epidermal growth
factor receptor 2
(HER2)-expressing
solid tumors
(DESTINY
-PanTumor02).
Yoshino, T Trastuzumab Rapid Abstract Session C: Cancers of the Colon,
deruxtecan (T Rectum, and Anus
-DXd; DS-8201) in
patients (pts)
with HER2
-expressing
metastatic
colorectal cancer
(mCRC): Final
results from a
phase 2,
multicenter, open
-label study
(DESTINY-CRC01).
Raghav, Trastuzumab Trials in Progress Poster Session C: Cancers of
KPS deruxtecan in the Colon, Rectum, and Anus
patients with
HER2
-overexpressing
locally advanced,
unresectable, or
metastatic
colorectal cancer
(mCRC): A
randomized,
multicenter,
phase 2 study
(DESTINY-CRC02).

Key AstraZeneca presentations during ASCO GU 2022

Lead Abstract Presentation details
author title
Immuno
-Oncology
Rosenberg, BAYOU: A Oral Abstract Session B: Urothelial Carcinoma18
JE phase II, February 202217:42 - 17:52 ET22:42 - 22:52 GMT
randomized,
multicenter,
double-blind,
study of
durvalumab
(D) in
combination
with olaparib
(O) for the
first-line
treatment of
platinum
-ineligible
patients with
unresectable,
stage IV
urothelial
carcinoma
(UC).
Powles, T A phase 3, Trials in Progress Poster Session B: Urothelial
randomized, Carcinoma
open-label,
multicenter,
global study
of the
efficacy and
safety of
durvalumab
(D) +
tremelimumab
(T) +
enfortumab
vedotin (EV)
or D + EV for
neoadjuvant
treatment in
cisplatin
-ineligible
muscle
-invasive
bladder
cancer (MIBC)
(VOLGA).
DNA Damage
Response
Saad, F PROpel: Phase Oral Abstract Session A: Prostate Cancer17
III trial of February 202216:00 - 16:10 ET21:00 - 21:10 GMT
olaparib
(ola) and
abiraterone
(abi) versus
placebo (pbo)
and abi as
first-line
(1L) therapy
for patients
(pts) with
metastatic
castration
-resistant
prostate
cancer
(mCRPC).

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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