AstraZeneca to highlight practice-changing cancer medicines in its pipeline at ASCO 2023; over 130 abstracts will feature 22 approved and potential new medicines

Sample article from our Health Care Sector

May 25, 2023 (press release) –

Tagrisso plenary presentation will demonstrate significantly improved overall survival
for patients with early-stage resectable EGFR-mutated lung cancer

Enhertu will show potential across a broad range of advanced HER2-expressing
advanced cancers

Lynparza and Imfinzi combination will demonstrate delay in progression in newly
diagnosed advanced ovarian cancer without a tumour BRCA mutation

 

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 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.

Additionally, several presentations and posters will highlight the Company’s commitment to improving outcomes in advanced lung cancer with next-wave treatments and novel combinations. These include:

  • 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 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.

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 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 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)

Lead Author

Tumour drivers and resistance

Lead Author

Herbst, R

Abstract Title

Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR mutated‑ (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).

 

Presentation details (CDT)

Abstract #LBA3

Plenary Session

4 June 2023

2:17pm

Lead Author

Oliveira, M

Abstract Title

Clinical activity of camizestrant, a next-generation SERD, versus fulvestrant in patients with a detectable ESR1 mutation: Exploratory analysis of the SERENA-2 Phase 2 trial.

Presentation details (CDT)

Abstract #1066

Poster Session

Breast Cancer—Metastatic

4 June 2023

8:00am

Lead Author

Antibody drug conjugates

Lead Author

Meric-Bernstam, F

Abstract Title

Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) interim results.

Presentation details (CDT)

Abstract #LBA3000

Oral Abstract Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

5 June 2023

8:00am

Lead Author

Raghav, K

Abstract Title

Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-overexpressing/amplified (HER2+) metastatic colorectal cancer (mCRC): Primary results from the multicenter, randomized, Phase 2 DESTINY-CRC02 study.

Presentation details (CDT)

Abstract #3501

Oral Abstract Session Gastrointestinal Cancer—Colorectal and Anal

4 June 2023

8:12am

Lead Author

Krop, I

Abstract Title

An age-specific pooled analysis of trastuzumab deruxtecan (T‑DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03.

Presentation details (CDT)

Abstract #1006

Oral Abstract Session Breast Cancer—Metastatic

5 June 2023

1:30pm

Lead Author

Goto, Y

Abstract Title

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) in advanced non-small cell lung cancer (aNSCLC).

Presentation details (CDT)

Abstract #9004

Oral Abstract Session Lung Cancer—Non-Small Cell Metastatic

6 June 2023

10:57am

Lead Author

Aggarwal, C

Abstract Title

EGRET: A first-in-human study of the novel antibody-drug conjugate (ADC) AZD9592 as monotherapy or combined with other anticancer agents in patients (pts) with advanced solid tumors.

Presentation details (CDT)

Abstract #TPS3156

Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

3 June 2023

8:00am

Lead Author

Borghaei, H

Abstract Title

TROPION-Lung04: Phase 1b, multicenter study of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy ± carboplatin in advanced/metastatic non-small cell lung cancer (mNSCLC).

 

Presentation details (CDT)

Abstract#TPS3158

Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

3 June 2023

8:00am

Lead Author

DNA damage response

Lead Author

Harter, P

Abstract Title

Durvalumab with paclitaxel/carboplatin (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.

Presentation details (CDT)

Abstract #LBA5506

Oral Abstract Session Gynecologic Cancer

3 June 2023

5:12pm

Lead Author

Armstrong, A

Abstract Title

Health-related quality of life (HRQoL) and pain 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.

Presentation details (CDT)

Abstract #5012

Poster Discussion Genitourinary Cancer—Prostate, Testicular, and Penile Session

3 June 2023

1:27pm

Lead Author

Immuno-Oncology

Lead Author

Hübner, H

Abstract Title

RNA expression levels from peripheral immune 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.

Presentation details (CDT)

Abstract #1011

Oral Abstract Session

Clinical Science Symposium:  Harnessing the Breast Cancer Immune Response

3 June 2023

1:51pm

Lead Author

Lau, G

Abstract Title

Outcomes by occurrence of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the Phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC).

Presentation details (CDT)

Abstract #4004

Oral Abstract Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

2 June 2023

3:57pm

Lead Author

Besse, B

Abstract Title

LATIFY: Phase 3 study of ceralasertib + 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.

Presentation details (CDT)

Abstract #TPS9161

Poster Session Lung Cancer—Non-Small Cell Metastatic

4 June 2023

8:00am (CDT)

Lead Author

Rohrberg, K

Abstract Title

Safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of AZD2936, a bispecific antibody targeting PD-1 and TIGIT, in checkpoint inhibitor (CPI)-experienced advanced/metastatic non-small-cell lung cancer (NSCLC): First report of ARTEMIDE-01.

Presentation details (CDT)

Abstract #9050

Poster Session Lung Cancer—Non-Small Cell Metastatic

4 June 2023

8:00am

Lead Author

Guisier, F

Abstract Title

NeoCOAST-2: A Phase 2 study of neoadjuvant 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).

Presentation details (CDT)

Abstract #TPS8604

Poster Session Lung Cancer—Non-Small Cell Local Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Lead Author

Robinson, C

Abstract Title

Phase 3 study of durvalumab with SBRT for unresected stage I/II, lymph-node negative NSCLC (PACIFIC-4/RTOG3515).

Presentation details (CDT)

Abstract #TPS8607

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Lead Author

Özgüroğlu, M

Abstract Title

Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8).

Presentation details (CDT)

Abstract #TPS8609

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Lead Author

Barlesi, F

Abstract Title

Phase 3 study of durvalumab combined with oleclumab or monalizumab in patients with unresectable stage III NSCLC (PACIFIC-9).

Presentation details (CDT)

Abstract #TPS8610

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

8:00am

Lead Author

Ganti, A

Abstract Title

The prognostic value of patient reported outcomes (PROs) and clinical/demographic variables in the CASPIAN study.

Presentation details (CDT)

Abstract #8516

Poster Discussion Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2023

11:45am

Lead Author

Lau, G

Abstract Title

Temporal patterns of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the Phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC).

Presentation details (CDT)

Abstract #4073

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

5 June 2023

8:00am

Lead Author

Coveler, A

Abstract Title

Safety and clinical activity of oleclumab (O) ± durvalumab (D) + chemotherapy (CT) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC): A Phase 1b/2 randomized study.

Presentation details (CDT)

Abstract #4136

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

5 June 2023

8:00am

Lead Author

Haematology

Lead Author

Kittai, A

Abstract Title

A matching-adjusted indirect comparison (MAIC) of the efficacy and safety of acalabrutinib (acala) versus zanubrutinib (zanu) in relapsed or refractory chronic lymphocytic leukemia (RR CLL).

Presentation details (CDT)

Abstract #7540

Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

5 June 2023

8:00am

Lead Author

Nair, R

Abstract Title

High complete response rate with TNB-486 in relapsed/refractory follicular lymphoma: Interim results an ongoing Phase 1 study.

Presentation details (CDT)

Abstract #7524

Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

5 June 2023

8:00am

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 and follow the Company on Twitter @AstraZeneca.

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