AstraZeneca PLC - AZN STOCK NEWS

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.

Daiichi Sankyo and AstraZeneca announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for ENHERTU, a HER2-directed therapy for metastatic breast cancer. This application received Priority Review status due to its potential to significantly improve treatment outcomes. ENHERTU demonstrated survival benefits in the DESTINY-Breast04 trial, marking a breakthrough for patients with HER2 low breast cancer. The FDA's decision is expected in Q4 2022 under the Real-Time Oncology Review and Project Orbis initiatives.

Daiichi Sankyo and AstraZeneca's ENHERTU has received EU approval as a monotherapy for adults with unresectable or metastatic HER2 positive breast cancer, marking an earlier treatment option based on the DESTINY-Breast03 trial. This pivotal phase 3 trial showed a remarkable 72% reduction in disease progression or death risk compared to trastuzumab emtansine. The approval extends market protection for ENHERTU by one year, affirming its significant clinical benefits. AstraZeneca is due to pay Daiichi Sankyo $75 million as a milestone for this approval.

AstraZeneca unveiled findings from the HIMALAYA and TOPAZ-1 Phase III trials, indicating that IMFINZI combined with tremelimumab significantly enhances overall survival in patients with unresectable liver cancer and advanced biliary tract cancer when compared to standard treatments. The results, presented at major oncology conferences in 2022, demonstrate that treatment benefits persisted across various liver function levels and tumor locations. Health-related quality-of-life metrics also favored IMFINZI. These data strengthen the case for IMFINZI's use in challenging cancer types with high unmet needs.

AstraZeneca announced positive interim results from the AEGEAN Phase III trial, showing that IMFINZI (durvalumab) combined with neoadjuvant chemotherapy significantly improves pathologic complete response (pCR) rates in resectable non-small cell lung cancer (NSCLC). The safety profile was consistent with previous findings, and no reduction in surgery success rates was noted. The trial will continue to explore event-free survival as a primary endpoint. IMFINZI is already approved for use in unresectable Stage III NSCLC and is being evaluated in multiple ongoing trials across various cancer types.