Astrazeneca Plc - AZN STOCK NEWS

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.

AstraZeneca has received FDA approval for a new tablet formulation of CALQUENCE (acalabrutinib) to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and relapsed or refractory mantle cell lymphoma (MCL). The tablet is bioequivalent to the existing capsule formulation, offering the same efficacy and safety profile with the added benefit of co-administration with gastric acid-reducing agents. The approval follows positive results from the ELEVATE-PLUS trials, emphasizing the need for tailored treatment options for patients, particularly those with multiple conditions.

Innate Pharma announced that the INTERLINK-1 Phase 3 study, sponsored by AstraZeneca, did not meet the efficacy threshold during an interim analysis and will be discontinued. The trial evaluated monalizumab with cetuximab against cetuximab alone for patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Despite this setback, Innate remains optimistic about monalizumab's potential in lung cancer and continues to focus on ongoing studies like PACIFIC-9 and NeoCOAST-2. AstraZeneca will share data from the trial in the future.

AstraZeneca and Daiichi Sankyo's ENHERTU has received FDA acceptance for a supplemental Biologics License Application (sBLA) to treat HER2-low metastatic breast cancer. This represents a significant milestone as ENHERTU is the first HER2-targeted therapy showing a survival benefit in this patient group. The application is under Priority Review, with a decision expected in Q4 2022. The FDA's Real-Time Oncology Review and Project Orbis initiatives aim to expedite access to this new therapy, which may redefine treatment for patients previously excluded from HER2-targeted options.