AstraZeneca ASCO 2021 data support ambition to revolutionise cancer outcomes by treating earlier and transforming the patient experience

Lynparza is the first targeted medicine to show clinical benefit in the adjuvant setting for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer

Calquence shows sustained four-year clinical benefit in 1st-line chronic lymphocytic leukaemia and lower atrial fibrillation rates in previously treated patients vs. ibrutinib

Imfinzi five-year data represent longest-ever survival reported in a Phase III immunotherapy trial in unresectable Stage III lung cancer

AstraZeneca will present new data underscoring its ambition to redefine cancer care at the American Society of Clinical Oncology (ASCO) Annual Meeting, 4 to 8 June 2021.

More than 100 abstracts will feature 21 approved and potential new medicines across the Company’s industry-leading oncology portfolio, with four abstracts selected as late-breakers, 12 oral presentations and one plenary presentation.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Our data at ASCO this year show our unwavering resolve to revolutionise cancer care and strengthen our leading portfolio in lung and breast cancers as well as haematology. New results for Lynparza and Imfinzi continue to validate our strategy of treating cancer early in settings with curative intent, and data for Calquence deliver on our commitment to improve the patient experience by demonstrating efficacy with safe, tolerable medicines.”

Cristian Massacesi, Senior Vice President, Head of late-stage development, Oncology R&D said: “Over the past few years, the outlook for breast cancer patients with BRCA mutations has radically changed, and the OlympiA data at ASCO will represent another critical step forward. We have an opportunity to fundamentally change the prognosis for women with high-risk early disease and usher in a potential new standard of care in the adjuvant setting. Additionally, promising data in triple-negative breast cancer will challenge current treatment expectations and bring hope for new approaches in this aggressive form of the disease.”

Redefining survival by treating cancer earlier

A plenary presentation of results from the OlympiA Phase III trial in early breast cancer will highlight the impact of Lynparza (olaparib) on the risk of disease recurrence versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Lynparza is the first PARP inhibitor to demonstrate clinical benefit as an adjuvant treatment in early breast cancer. In February 2021, the trial’s Independent Data Monitoring Committee recommended moving to early primary analysis based on a planned interim analysis showing a sustainable and clinically relevant treatment effect in the primary endpoint of invasive disease-free survival.

Five-year overall survival data from the PACIFIC Phase III trial will continue to support the unprecedented and sustained survival benefits of Imfinzi (durvalumab) for patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent chemoradiation therapy. These data represent the longest-ever survival reported in a Phase III trial of immunotherapy in this treatment setting.

Additionally, an oral presentation of Phase II data from the externally sponsored GeparNuevo trial conducted by the German Breast Group will show initial potential of Imfinzi to improve outcomes in patients with early triple-negative breast cancer (TNBC) when added to standard neoadjuvant chemotherapy.

Transforming the patient experience

Four-year follow-up data from the ELEVATE-TN trial will confirm the sustained clinical benefit of either Calquence monotherapy or Calquence in combination with obinutuzumab, providing flexibility to tailor treatment for adults with treatment-naïve chronic lymphocytic leukaemia (CLL).

In addition, an oral presentation of detailed results from the ELEVATE-RR Phase III trial will demonstrate significantly lower atrial fibrillation, fewer cardiac events and fewer discontinuations with Calquence (acalabrutinib) versus ibrutinib in adults with previously treated CLL at high risk for progression. ELEVATE-RR is the first head-to-head Phase III trial of two Bruton’s tyrosine kinase inhibitors in CLL, confirming the favourable benefit-risk profile of Calquence for patients with CLL.

Updated data from DESTINY-Gastric01 and DESTINY-CRC01 will further support the potential role of Enhertu (trastuzumab deruxtecan) across HER2-targetable cancers. Additionally, data from a subgroup analysis of previously treated HER2-positive breast cancer patients with brain metastases in the DESTINY-Breast01 trial will reinforce the commitment to understanding the potential benefit of Enhertu in hard-to-treat patient populations.

Initial results will be shared from the BEGONIA Phase Ib/II trial testing Imfinzi combinations in metastatic TNBC, including with Enhertu. Also, data will be shared from a Phase II trial with ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, in combination with Imfinzi showing that this combination demonstrated promising anti-tumour activity in melanoma patients for whom prior anti-PD1 treatment had failed.

Additional evidence will underscore the need for improved central nervous system control and the role of next-generation tyrosine kinase inhibitors (TKIs) such as Tagrisso (osimertinib) in the treatment of advanced epidermal growth factor (EGFR)-mutated NSCLC, as shown in the REFLECT retrospective real-world analysis of first- and second-generation TKIs.

Advancing an industry-leading clinical development programme

In all, AstraZeneca will share 18 posters at ASCO describing trials-in-progress exploring novel medicines and combinations across multiple types and stages of cancer. These posters include:

·       Datopotamab deruxtecan (Dato-DXd) - the TROPION-Lung01 Phase III trial testing datopotamab deruxtecan in patients with previously treated metastatic NSCLC, and the BEGONIA trial testing Imfinzi in combination with datopotamab deruxtecan in metastatic TNBC

·       Enhertu - trials testing Enhertu alone or in various combinations, including: DESTINY-Breast07, DESTINY-PanTumor01, and DESTINY-CRC02

·       Imfinzi - the MATTERHORN Phase III trial of neoadjuvant-adjuvant Imfinzi and chemotherapy in resectable gastric and gastroesophageal junction cancer, and the BEGONIA Phase I/II trial testing Imfinzi in novel combinations for 1st-line treatment of patients with TNBC, including with Enhertu and datopotamab deruxtecan.

·       Calquence - the ESCALADE Phase III trial of Calquence in combination with standard chemotherapy for patients age 65 and younger newly diagnosed with diffuse large B-cell lymphoma, the most common type of non-Hodgkin lymphoma

·       Camizestrant (AZD9833) - the SERENA-4 Phase III trial comparing camizestrant, a next-generation oral selective oestrogen receptor degrader (SERD), plus palbociclib, versus anastrozole plus palbociclib, in patients with oestrogen receptor-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease

·       Adavosertib - the ADAGIO Phase II multicentre trial of the WEE1 inhibitor adavosertib as a treatment for recurrent or persistent uterine serous carcinoma, a highly aggressive form of endometrial cancer

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

Key AstraZeneca presentations during the 2021 ASCO Annual Meeting1

Lead author

Abstract title

Presentation details2

Immuno-Oncology

 

Spigel, D

Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial.

Abstract #8511

Poster Discussion Session

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

4 June 2021

 

Janjigian, Y

MATTERHORN: Efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy in resectable gastric and gastroesophageal junction cancer—A randomized, double-blind, placebo-controlled, phase 3 study.

Abstract #TPS4151

Poster Session

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2021

 

McCoon, P

T-cell receptor pharmacodynamics associated with survival and response to tremelimumab (T) in combination with durvalumab (D) in patients (pts) with unresectable hepatocellular carcinoma (uHCC).

Abstract #4087

Poster Session

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2021

 

Schmid, P

BEGONIA: Phase 1b/2 study of durvalumab (D) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC)—Initial results from arm 1, d+paclitaxel (P), and arm 6, d+trastuzumab deruxtecan (T-DXd).

 

Abstract #1023

Poster Discussion Session

Breast Cancer—Metastatic

4 June 2021

 

Schmid, P

BEGONIA: Phase 1b/2, open-label, platform study of the safety and efficacy of durvalumab (D) ± paclitaxel (P) with novel oncology therapies for first line metastatic triple-negative breast cancer (mTNBC): Addition of Arm 7, D + datopotamab deruxtecan (Dato-DXd; DS-1062).

 

Abstract #TPS1105

Poster Session

Breast Cancer—Metastatic

4 June 2021

 

Kwon, M

Phase II study of ceralasertib (AZD6738), in combination with durvalumab in patients with metastatic melanoma who have failed prior anti-PD-1 therapy.

 

Abstract #9514

Poster Discussion Session

Melanoma/Skin Cancers

4 June 2021

 

Suárez, C

Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer.

Abstract #4511

Poster Discussion Session

Genitourinary Cancer—Kidney and Bladder

4 June 2021

 

Tumour drivers and resistance

 

Janzic, U

Real-world outcomes and clinical characteristics of patients with brain metastases from EGFR mutated non-small cell lung cancer: Data from a large retrospective study (REFLECT).

Abstract #9086

Poster Session

Lung Cancer—Non-Small Cell Metastatic

4 June 2021

 

Im, S-A

SERENA-4: A phase 3 comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease.

 

Abstract #TPS1101

Poster Session

Breast Cancer—Metastatic

4 June 2021

 

Tada, H

Adjuvant gefitinib versus cisplatin/vinorelbine in Japanese patients with completely resected, EGFR-mutated, stage II-III non-small cell lung cancer (IMPACT, WJOG6410L): A randomized phase 3 trial.

Abstract #8501

Oral Abstract Session

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

6 June 2021

 

Antibody drug conjugates

 

Yoh, K

A randomized, phase 3 study of datopotamab deruxtecan (Dato-DXd; DS-1062) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (TROPION-Lung01).

 

Abstract #TPS9127

Poster Session

Lung Cancer – Non-small Cell Metastatic

4 June 2021

 

Andre, F

Trastuzumab deruxtecan (T-DXd) combinations in patients with HER2-positive advanced or metastatic breast cancer: A phase 1b/2, open-label, multicenter, dose-finding and dose-expansion study (DESTINY-Breast07).

 

Abstract #TPS1096

Poster Session

Breast Cancer—Metastatic

4 June 2021

 

Li, BT

A phase 2, multicenter, open-label study evaluating trastuzumab deruxtecan (T-DXd) for the treatment of solid tumors harboring specific HER2-activating mutations (DESTINY-PanTumor01).

Abstract #TPS3162

Poster Session

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

4 June 2021

 

Yoshino, T

Trastuzumab deruxtecan (T-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).

 

Abstract #3505

Oral Abstract Session

Gastrointestinal Cancer—Colorectal and Anal

7 June 2021

 

Raghav, K

Trastuzumab deruxtecan in patients with HER2-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC): A randomized, multicenter, phase 2 study (DESTINY-CRC02).

Abstract #TPS3620

Poster Session

Gastrointestinal Cancer—Colorectal and Anal

4 June 2021

 

Jerusalem, G

Trastuzumab deruxtecan (T-DXd) in patients with HER2+ metastatic breast cancer with brain metastases: a subgroup analysis of the DESTINY-Breast01 trial.

Abstract #526

Poster Session

Breast Cancer— Local/Regional/Adjuvant

4 June 2021

 

Yamaguchi, K

Trastuzumab deruxtecan (T-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).

 

Abstract #4048

Poster Session

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2021

 

DNA damage response

 

Tutt, A

OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high risk HER2-negative early breast cancer.

 

Abstract #LBA1

Plenary Session

6 June 2021, 1:00pm EDT

 

Liu, JF

ADAGIO: A phase IIb, open-label, single-arm, multicenter study assessing the efficacy and safety of adavosertib (AZD1775) as treatment for recurrent or persistent uterine serous carcinoma.

Abstract #TPS5612

Poster Session

Gynecologic Cancer

4 June 2021

Poveda, A

Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase IIIb OPINION primary analysis.

 

Abstract #5545

Poster Session

Gynecologic Cancer

4 June 2021

 

Matthews, CA

Olaparib treatment (Tx) in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) by BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: Overall survival (OS) results from the phase II LIGHT study.

 

Abstract #5515

Poster Discussion Session

Gynecologic Cancer

4 June 2021

 

Pautier, P

Progression-free survival (PFS) and second PFS (PFS2) by disease stage in patients (pts) with homologous recombination deficiency (HRD)-positive newly diagnosed advanced ovarian cancer receiving bevacizumab (bev) with olaparib/placebo maintenance in the phase III PAOLA-1/ENGOT-ov25 trial.

 

Abstract #5514

Poster Discussion Session

Gynecologic Cancer

4 June 2021

 

Haematology

 

Byrd, J

First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia.

Abstract #7500

Oral Abstract Session

Hematologic Malignancies

7 June 2021

 

Sharman, JP

Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Elevate-TN four-year follow up.

Abstract #7509

Poster Discussion Session

Hematologic Malignancies

4 June 2021

 

Sehn, L

ESCALADE: A phase 3 study of acalabrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for patients ≤65y with untreated non-germinal center B-cell–like (non-GCB) diffuse large B-cell lymphoma (DLBCL).

 

Abstract #TPS7572

Poster Session

Hematologic Malignancies

4 June 2021

 

174 company-sponsored or supported abstracts will be presented at ASCO 2021.

2Beginning Friday 4 June 2021 09:00 EDT oral presentations, poster discussions and poster sessions will be available on demand for 180 days including video and slide presentations and discussant commentary.

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 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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  • Cancer