Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca and Merck announced that LYNPARZA (olaparib) is now approved in the US for adjuvant treatment of germline BRCA-mutated, HER2-negative high-risk early breast cancer patients. This decision follows results from the OlympiA Phase III trial, where LYNPARZA showed a 42% reduction in invasive disease recurrence and a 32% decrease in the risk of death versus placebo. AstraZeneca expects a $175 million milestone payment from Merck as a result of this approval.

Honeywell and AstraZeneca announced a partnership to develop next-generation respiratory inhalers utilizing near-zero global warming potential (GWP) propellants. This collaboration addresses the needs of 384 million COPD and 339 million asthma sufferers, aiming to reduce greenhouse gas emissions by up to 99.9% compared to traditional inhalers. Honeywell's Solstice Air, a non-flammable propellant, has shown promising results in clinical trials. AstraZeneca plans to transition its Breztri Aerosphere medicine to this innovative platform pending regulatory approval. Both companies aim for sustainable healthcare solutions.

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.