Astrazeneca Plc - AZN STOCK NEWS

AstraZeneca and Daiichi Sankyo reported positive results from the DESTINY-Breast04 Phase III trial of ENHERTU (fam-trastuzumab deruxtecan-nxki) for HER2-low metastatic breast cancer. The trial showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. Approximately 55% of breast cancer patients have HER2-low tumors, previously ineligible for targeted therapy. ENHERTU's safety profile was consistent with prior studies, with no new safety concerns identified. This data could redefine treatment strategies for breast cancer.

The pivotal DESTINY-Breast04 phase 3 trial demonstrated that ENHERTU® (trastuzumab deruxtecan) significantly improves progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer, compared to standard chemotherapy. This trial is historic as it marks the first HER2 directed therapy to show benefits in this patient group, potentially redefining breast cancer treatment classifications. Both Daiichi Sankyo and AstraZeneca are planning global regulatory submissions based on these promising results.

AstraZeneca and Merck announced positive results from the PROpel Phase III trial, demonstrating that LYNPARZA (olaparib) combined with abiraterone significantly improves radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC). The combination therapy reduced the risk of disease progression or death by 34% compared to abiraterone alone. Median rPFS was 24.8 months for the combination versus 16.6 months for abiraterone alone. These findings may position the combination as a new standard of care for mCRPC if approved.

Eplontersen has received Orphan Drug Designation from the FDA for treating transthyretin-mediated amyloidosis, a serious progressive condition. Also known as IONIS-TTR-LRx, Eplontersen is undergoing Phase III trials for ATTR-CM and ATTR-PN. The FDA grants this status to drugs for rare diseases affecting less than 200,000 people in the U.S. AstraZeneca and Ionis Pharmaceuticals will jointly develop Eplontersen, with regulatory approval expected for hereditary ATTR-PN by late 2022, signaling promising advancements in treatment options for patients.

AstraZeneca announced positive results from the HIMALAYA Phase III trial, demonstrating that a single dose of tremelimumab combined with IMFINZI reduced the risk of death by 22% in patients with unresectable liver cancer compared to sorafenib. The median overall survival (OS) was 16.4 months for the STRIDE regimen versus 13.8 months for sorafenib. The trial showed improved safety profiles, with fewer severe liver toxicities and treatment discontinuations. Findings will be presented at the ASCO Gastrointestinal Cancers Symposium on January 21, 2022.

AstraZeneca announced positive results from the TOPAZ-1 Phase III trial, revealing that IMFINZI® (durvalumab) combined with chemotherapy significantly improves overall survival and progression-free survival for patients with advanced biliary tract cancer compared to chemotherapy alone. The trial showed a 20% reduction in the risk of death and a median overall survival of 12.8 months versus 11.5 months for chemotherapy. The combination also resulted in a 25% reduction in disease progression risk. This promising data will be presented at the ASCO Gastrointestinal Cancers Symposium on January 21, 2022.

AstraZeneca and Daiichi Sankyo's Enhertu has received acceptance for a supplemental Biologics License Application in the US for treating advanced HER2-positive breast cancer after previous anti-HER2 regimens. The FDA has granted it Priority Review under its Real-Time Oncology Review and Project Orbis initiatives, aimed at expediting effective cancer treatments. Enhertu demonstrated a 72% reduction in disease progression risk versus T-DM1 in trials, further emphasizing the need for more treatment options in this area.

Daiichi Sankyo and AstraZeneca announced the FDA's acceptance of the supplemental Biologics License Application (sBLA) for ENHERTU, designed for adult patients with unresectable or metastatic HER2 positive breast cancer. The application has received Priority Review and is part of the FDA's Real-Time Oncology Review and Project Orbis initiatives. ENHERTU showed a 72% reduction in disease progression or death versus T-DM1 in the DESTINY-Breast03 trial, with notable improvements in overall survival and objective response rates. The FDA action date is in Q2 2022.