AstraZeneca ASCO 2021 Data Support Ambition to Revolutionize Cancer Outcomes by Treating Earlier...

ORIGINAL SOURCE: Businesswire
– 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 leukemia 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 –

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca will present new data underscoring its ambition to redefine cancer care at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 4 to 8, 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 revolutionize cancer care and strengthen our leading portfolio in lung and breast cancers as well as hematology. New results for LYNPARZA® (olaparib) and IMFINZI® (durvalumab) 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 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 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® (acalabrutinib) monotherapy or CALQUENCE in combination with obinutuzumab, providing flexibility to tailor treatment for adults with treatment-naïve chronic lymphocytic leukemia (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 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 (TKIs) in CLL, confirming the favorable 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 (fam-trastuzumab deruxtecan-nxki) 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-tumor 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 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 program

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 IMFINZIin 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 estrogen receptor degrader (SERD), plus palbociclib, versus anastrozole plus palbociclib, in patients with estrogen receptor-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease
• Adavosertib - the ADAGIO Phase II multicenter 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 commercialized in collaboration with Merck & Co., Inc. AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialize ENHERTU and datopotamab deruxtecan globally.

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 catalyze 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.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow the Company on Twitter @AstraZenecaUS.