Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca will showcase new cancer treatment data at ESMO Congress 2022, demonstrating efficacy and safety with 15 medicines across various cancers. Key highlights include long-term survival benefits for LYNPARZA in ovarian cancer and promising results from IMFINZI in liver and lung cancers. New findings on ENHERTU reinforce its potential in HER2-targetable cancers, while data from MEDI5752 will advance next-gen immunotherapy. The company aims to redefine cancer care by improving patient survival in areas of high unmet medical need.

AstraZeneca announced that the FDA has granted Priority Review for its supplemental New Drug Application (sNDA) for LYNPARZA (olaparib) in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). This is significant as it could be the first combination therapy of a PARP inhibitor with a new hormonal agent, addressing a critical unmet need. The FDA's action date is expected in Q4 2022. The PROpel Phase III trial showed that the combination reduced disease progression risk by 34% compared to standard care.

Daiichi Sankyo and AstraZeneca announced positive topline results from the DESTINY-Breast02 phase 3 trial of ENHERTU, demonstrating significant improvement in progression-free survival in patients with HER2 positive metastatic breast cancer previously treated with T-DM1. The trial met both primary and key secondary endpoints, showing improved overall survival. Safety profiles remained consistent with earlier trials, with no new safety concerns. The trial results contribute to regulatory discussions for ENHERTU's current breast cancer indication.

AstraZeneca and Daiichi Sankyo's ENHERTU® has received FDA approval for treating unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations in adults previously treated with systemic therapy. The accelerated approval is based on the DESTINY-Lung02 trial, which reported a confirmed objective response rate of 57.7% (n=52) and a median duration of response of 8.7 months. A milestone payment of $125 million is due from AstraZeneca to Daiichi Sankyo following this approval. ENHERTU is also approved for other HER2-positive cancers, reflecting its broad application potential.

Daiichi Sankyo and AstraZeneca’s ENHERTU has gained U.S. FDA approval for treating unresectable or metastatic non-small cell lung cancer (NSCLC) in patients with HER2 mutations after prior therapy. The decision is based on the DESTINY-Lung02 trial, showing a confirmed objective response rate of 57.7%. This approval marks the third tumor type for ENHERTU, emphasizing its significance. The FDA also approved diagnostic tests for HER2 mutations, enhancing treatment access. AstraZeneca will pay Daiichi Sankyo $125 million as a milestone payment related to this approval.

AstraZeneca has reported preliminary results from the SAVANNAH Phase II trial, showing that the combination of TAGRISSO (osimertinib) and savolitinib has a 49% objective response rate (ORR) in EGFR-mutated non-small cell lung cancer (NSCLC) patients with high MET levels who previously progressed on TAGRISSO. The ORR is significantly higher (52%) in patients not treated with prior chemotherapy. The global SAFFRON Phase III trial is set to evaluate this combination against standard chemotherapy, highlighting the potential for a less toxic, more effective treatment option.

AstraZeneca and Daiichi Sankyo's ENHERTU has gained FDA approval for treating adult patients with unresectable or metastatic HER2-low breast cancer, marking a significant advancement in the oncology field. Based on the DESTINY-Breast04 trial, ENHERTU demonstrated a 50% reduction in disease progression risk and extended overall survival by over six months compared to traditional chemotherapy. This breakthrough is critical as half of breast cancer patients are HER2-low, and previously lacked effective targeted therapies. AstraZeneca will pay Daiichi Sankyo $200 million as a milestone following FDA approval.

Daiichi Sankyo and AstraZeneca announced that the FDA has approved ENHERTU for adult patients with unresectable or metastatic HER2 low breast cancer. This decision follows the successful DESTINY-Breast04 trial, which showed ENHERTU reduced disease progression or death by 50% and offered a median overall survival of 23.9 months compared to 17.5 months with chemotherapy. AstraZeneca will pay Daiichi Sankyo $200 million as a milestone payment following this approval. ENHERTU's safety includes warnings for interstitial lung disease and embryo-fetal toxicity.