Benzinga | Jan 13, 2022 11:43AM EST

AstraZeneca Announced it Aims to Redefine Liver, Biliary Tract and Prostate Cancer Treatment with Imfinzi and Lynparza Data to be Presented at ASCO Genitourinary Cancers Symposium

mfinzi combinations show meaningful overall survival in liver and biliary tract cancers

Lynparza combined with abiraterone will demonstrate clinical benefit regardless of biomarker status in metastatic castration-resistant prostate cancerAstraZeneca 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 GIA 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 GUA 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 cancersAt 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,andwith Daiichi Sankyo Company Limited to develop and commercialise Enhertu.