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2022-05-23

AstraZeneca aims to transform cancer care with practice-changing data at ASCO 2022

Enhertu data will show the potential to improve survival for metastatic breast cancer patients and define a new segment of HER2-low disease.
Results from multiple trials further reinforce strength of industry-leading portfolio and pipeline, including novel combinations, across cancers with high unmet need.

AstraZeneca advances its ambition to redefine cancer care with new data to be presented across its diverse and industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) Annual Meeting, 3 to 7 June 2022.

A total of 18 approved and potential new medicines from AstraZeneca will be featured across more than 100 abstracts, including nine oral presentations and a plenary presentation of the DESTINY-Breast04 Phase III trial (https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-improves-pfs-and-os-in-her2-low-bc.html) for Enhertu (trastuzumab deruxtecan) in HER2-low metastatic breast cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our five leading Oncology medicines have each set new standards for patient outcomes across many cancers. Our data at ASCO will showcase our continued investment in driving innovation with these medicines as well as their long-term impact in real-world settings. In particular, the groundbreaking data from DESTINY-Breast04 will show the potential of Enhertu to treat patients with HER2-low metastatic breast cancer who have never before been eligible for HER2-targeted treatments."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "At AstraZeneca, we are pioneering new biomarkers and novel therapeutic modalities in our ambition to attack cancer from every angle and deliver personalised medicines to more patients. The results from DESTINY-Breast04 support the potential for Enhertu to redefine the classification and treatment of breast cancer across the spectrum of HER2 expression. We are also excited to share promising clinical data for our bispecific PD1-CTLA4 antibody MEDI5752 in advanced renal cell carcinoma, designed to have both of these clinically validated checkpoint targets in one molecule, delivering efficacy with an improved tolerability profile."

Leading through disruption in breast cancer

A late-breaking plenary presentation will highlight the potentially practice-changing results of the DESTINY-Breast04 trial of Enhertu in patients with HER2-low metastatic breast cancer. DESTINY-Breast04 is the first-ever Phase III trial of a HER2-directed therapy to show statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status compared to standard-of-care chemotherapy.

Additionally, data from a retrospective study will estimate the prevalence of HER2-low breast cancer and describe its clinical and pathological characteristics, to help identify patients with HER2-low expressing tumours who may benefit from HER2-targeted therapy.

Further results will be shared from dose-finding and dose-expansion studies of Enhertu in combination with other anti-cancer agents in patients with advanced or metastatic HER2-positive breast cancer (DESTINY-Breast07) and HER2-low breast cancer (DESTINY-Breast08).

Data will also be presented from a safety follow-up of the DESTINY-Breast03 Phase III trial of Enhertu in the treatment of patients with unresectable or metastatic HER2-positive breast cancer previously treated with trastuzumab and a taxane. Enhertu was recently approved in the US (https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/enhertu-approved-in-us-for-2l-her2-positive-breast-cancer.html) for patients in this setting.

Revealing the full potential of an industry-leading portfolio and pipeline

Beyond breast cancer, AstraZeneca will share results from multiple trials highlighting its focus on delivering life-changing cancer medicines for patients with high unmet need. Data will also support the Company's commitment to realising the full potential of its leading medicines with ongoing analyses, real-world data and research into novel combinations.

  • MEDI5752 - An oral presentation will share safety and clinical activity results for MEDI5752 in patients with advanced renal cell carcinoma as a monotherapy treatment. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4.

  • Calquence (acalabrutinib) - Updated data from the ELEVATE-TN and ASCEND Phase III trials will highlight long-term safety and efficacy results of Calquence in patients with chronic lymphocytic leukaemia (CLL) regardless of line of therapy.

Presentations include updated data with approximately five-years of median follow-up from the ELEVATE-TN trial, which has demonstrated sustained clinical benefit of Calquence either in combination with obinutuzumab or as monotherapy compared to obinutuzumab plus chlorambucil, providing flexibility to tailor treatment for adults with treatment-naïve CLL.

Additionally, updated results from the ASCEND Phase III trial with approximately four years of median follow-up will highlight the sustained reduction of disease progression or death for Calquence compared to idelalisib plus rituximab or bendamustine plus rituximab in patients with relapsed or refractory CLL, as well as a maintained safety profile.

  • Imfinzi (durvalumab) - Patient-reported outcomes from the HIMALAYA trial will highlight quality of life for patients treated with a single priming dose of tremelimumab added to Imfinzi in 1st-line unresectable liver cancer (STRIDE regimen). HIMALAYA is the first Phase III trial to show that a dual immunotherapy regimen has improved OS versus sorafenib in this setting. Tremelimumab with Imfinzi was recently accepted (https://www.astrazeneca.com/media-centre/press-releases/2022/tremelimumab-us-priority-review-imfinzi-combo.html) under Priority Review in the US by the Food and Drug Administration (FDA) based on this trial.

Patient-reported outcomes will also be presented from the TOPAZ-1 trial of Imfinzi plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line advanced biliary tract cancer. TOPAZ-1 is the first Phase III trial to show improved survival with an immunotherapy combination versus chemotherapy alone in this setting.

An additional regional subgroup analysis for the TOPAZ-1 trial will compare efficacy outcomes, including OS, for Asian patients with other geographies. Imfinzi plus chemotherapy was recently granted (https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-combo-granted-priority-review-for-btc.html) Priority Review in the US by the FDA based on this trial.

Further clinically relevant safety data from the positive POSEIDON Phase III trial of Imfinzi, tremelimumab and chemotherapy in 1st-line metastatic non-small cell lung cancer (NSCLC) will also be presented.

  • Lynparza (olaparib) - Data from the PROpel Phase III trial will further reinforce the safety profile of Lynparza plus abiraterone in the treatment of 1st-line metastatic castration-resistant prostate cancer (mCRPC). These data build on PROpel efficacy data, which demonstrated that this combination significantly delayed disease progression versus standard-of-care abiraterone in 1st-line mCRPC in patients with or without homologous recombination repair gene mutations. Lynparza is the first PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent versus abiraterone alone in this setting.

  • Tagrisso (osimertinib) - Results will be shared from the externally sponsored OPAL Phase II trial in previously untreated EGFR-mutated (EGFRm) NSCLC that evaluated whether the addition of platinum-based chemotherapy to Tagrisso can improve patient outcomes. This combination is also being tested in the ongoing FLAURA2 Phase III trial.

Real-world data will also be presented to better inform unmet needs and treatment strategies among patients with resectable early-stage NSCLC, providing valuable insights into EGFRm disease prevalence and rates of recurrence, despite adjuvant chemotherapy, in this population. Tagrisso is approved for the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC based on the ADAURA Phase III trial.

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 with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ASCO 2022

Lead author Abstract title Presentation details
Antibody
drug
conjugates
Modi, S Trastuzumab Abstract #LBA3Plenary Session5 June 20222:17pm
deruxtecan (T (CDT)
-DXd) versus
treatment of
physician's
choice (TPC) in
patients (pts)
with HER2-low
unresectable
and/or metastatic
breast cancer
(mBC): Results of
DESTINY-Breast04,
a randomized,
phase 3 study.
Hamilton, Trastuzumab Abstract #1000Oral Abstract Session Breast
EP deruxtecan (T Cancer-Metastatic 4 June 20221:15pm (CDT)
-DXd) versus
trastuzumab
emtansine (T-DM1)
in patients (pts)
with HER2
-positive (HER2+)
unresectable
and/or metastatic
breast cancer
(mBC): Safety
follow-up of the
randomized, phase
3 study DESTINY
-Breast03.
Andre, F Dose-finding and Abstract #3025Poster Session Developmental
-expansion Therapeutics-Molecularly Targeted Agents and
studies of Tumor Biology5 June 20228:00am (CDT)
trastuzumab
deruxtecan in
combination with
other anti-cancer
agents in
patients (pts)
with
advanced/metastati
c HER2+ (DESTINY
-Breast07 [DB
-07]) and HER2
-low (DESTINY
-Breast08 [DB
-08]) breast
cancer (BC).
Immuno
-Oncology
Cho, BC Durvalumab (D) +/ Abstract #9035Poster Session Lung Cancer-Non
- tremelimumab -Small Cell Metastatic 6 June 20228:00am (CDT)
(T) +
chemotherapy (CT)
in first-line
(1L) metastatic
(m) NSCLC: AE
management in
POSEIDON.
Sangro, B Patient-reported Abstract #4074Poster Session Gastrointestinal
outcomes from the Cancer-Gastroesophageal, Pancreatic, and
phase 3 HIMALAYA Hepatobiliary4 June 20228:00am (CDT)
study of
tremelimumab plus
durvalumab in
unresectable
hepatocellular
carcinoma.
Burris III, Patient-reported Abstract #4070Poster Session Gastrointestinal
HA outcomes for the Cancer-Gastroesophageal, Pancreatic, and
phase 3 TOPAZ-1 Hepatobiliary4 June 20228:00am (CDT)
study of
durvalumab plus
gemcitabine and
cisplatin in
advanced biliary
tract cancer.
Vogel, A Regional subgroup Abstract #4075Poster Session Gastrointestinal
analysis of the Cancer-Gastroesophageal, Pancreatic, and
phase 3 ...

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