Astrazeneca Plc Stock Price, News & Analysis

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.

Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan has gained a positive recommendation from the European Medicines Agency for treating HER2 positive metastatic breast cancer. This recommendation is based on the DESTINY-Breast03 trial, which demonstrated a 72% reduction in disease progression risk compared to T-DM1. The therapy's safety profile aligns with previous studies, and the European Commission will now evaluate this recommendation. With over 530,000 breast cancer diagnoses in Europe annually, there is a critical need for effective treatment options.

ALXN1840, an investigational treatment for Wilson disease, demonstrated significant efficacy in a Phase III trial. The study showed a three-times increase in copper mobilization from tissues compared to standard care (p<0.0001). Patients experienced rapid responses by four weeks, sustained for 48 weeks. Notably, initial improvements in neurological scores were observed in symptomatic patients. The treatment was well tolerated, with most adverse events being non-serious. This pioneering approach could redefine management strategies for Wilson disease, which has seen limited innovation for decades.

Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan has received validation from the European Medicines Agency (EMA) for a Type II Variation application. This approval is for treating adult patients with unresectable or metastatic HER2 low breast cancer who have undergone prior systemic therapy. Results from the DESTINY-Breast04 trial indicated significant improvements in progression-free and overall survival compared to standard chemotherapy. The application marks a potential shift in treatment options for patients with low HER2 expression, expanding the reach of targeted therapy.

Results from the PROpel Phase III trial reveal that LYNPARZA (olaparib), in combination with abiraterone, significantly enhances radiographic progression-free survival (rPFS) by 34% for metastatic castration-resistant prostate cancer (mCRPC) patients, regardless of HRR gene mutations. The combination showed a median rPFS of 24.8 months, compared to 16.6 months for abiraterone alone. The data published in NEJM Evidence highlights the need for new first-line treatment options and suggests potential approval for broader patient groups. Safety profiles align with prior trials, indicating no detrimental health effects.

AstraZeneca and Ionis Pharmaceuticals announced positive interim results from the NEURO-TTRansform Phase III trial for eplontersen, a treatment for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). After 35 weeks, the drug met co-primary endpoints, showing significant reductions in serum transthyretin levels and improvements in neuropathy impairment scores. Eplontersen also demonstrated a favorable safety profile and improved quality of life metrics. Following these results, the companies plan to file a New Drug Application with the FDA in 2022.