Astrazeneca Plc - AZN STOCK NEWS

Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for ENHERTU® (trastuzumab deruxtecan) as a monotherapy for treating adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting. The application is based on data from the DESTINY-Breast06 phase 3 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to standard chemotherapy. ENHERTU is a HER2 directed DXd antibody drug conjugate jointly developed by Daiichi Sankyo and AstraZeneca. This submission aims to expand ENHERTU's existing indication in HER2 low metastatic breast cancer to include earlier disease stages and a broader patient population.

AstraZeneca’s IMFINZI® (durvalumab) has been approved by the FDA for treating resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) in adults without EGFR mutations or ALK rearrangements. This approval is based on the AEGEAN Phase III trial, which showed a 32% reduction in the risk of recurrence, progression, or death compared to neoadjuvant chemotherapy alone.

The trial results indicated an EFS hazard ratio of 0.68 (95% CI 0.53-0.88, P=0.003902) and a pCR rate of 17.2% for the IMFINZI regimen versus 4.3% for chemotherapy alone. The regimen includes IMFINZI with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy post-surgery.

IMFINZI is also approved in the UK, Switzerland, and Taiwan based on AEGEAN results, with reviews ongoing in other regions. Notably, the regimen did not compromise surgical outcomes and was well tolerated with no new safety signals.

AstraZeneca's IMFINZI® (durvalumab) has been granted Priority Review and Breakthrough Therapy Designation by the FDA for patients with -stage small cell lung cancer (LS-SCLC). This is based on the positive results from the ADRIATIC Phase III trial, which showed significant improvements in overall survival and progression-free survival.

Key points:

• IMFINZI reduced the risk of death by 27% vs placebo
• Estimated median overall survival was 55.9 months for IMFINZI vs 33.4 months for placebo
• 57% of IMFINZI-treated patients were alive at 3 years vs 48% on placebo
• IMFINZI reduced the risk of disease progression or death by 24%
• The safety profile was consistent with known data

This Priority Review highlights IMFINZI's potential to transform outcomes for LS-SCLC patients, an area with no new treatments in 40 years.

AstraZeneca's CALQUENCE® (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has shown significant improvement in progression-free survival compared to standard chemoimmunotherapy in previously untreated chronic lymphocytic leukemia (CLL) patients. The AMPLIFY Phase III trial also demonstrated a favorable trend in overall survival. CLL, the most common adult leukemia, affects approximately 40,000 first-line patients annually. The trial results suggest CALQUENCE's potential as both a treat-to-progression and fixed-duration treatment, offering more options for patients and healthcare providers. The safety profile was consistent with known data, showing low rates of cardiac toxicity. These findings reinforce AstraZeneca's leadership in CLL treatment advancements.

AstraZeneca (AZN) has reported strong financial results for H1 and Q2 2024, leading to an upgrade in FY 2024 guidance. Total Revenue increased by 18% to $25,617m, driven by an 18% rise in Product Sales and growth in Alliance Revenue. Key highlights include:

- Oncology, CVRM, R&I, and Rare Disease segments all saw 22% growth or higher
- Core EPS increased by 5% to $4.03
- Interim dividend increased by 7c to $1.00
- FY 2024 guidance upgraded: Total Revenue and Core EPS now expected to grow by a mid teens percentage

The company also reported positive Phase III study results and regulatory approvals for several key drugs, including Imfinzi, Calquence, Enhertu, Truqap, and Tagrisso.

Pinetree Therapeutics has entered into an exclusive option and global license agreement with AstraZeneca for a preclinical EGFR degrader candidate. The deal includes:

• Up to $45 million in upfront and near-term payments
• Total deal value of over $500 million, including potential milestone payments
• Tiered royalties on net sales worldwide

Pinetree's pan-EGFR degrader, developed from their proprietary AbReptor™ multispecific antibody platform, has shown promising preclinical anti-tumor activity in drug- and TKI-resistant tumors. The agreement allows AstraZeneca to exclusively license the candidate for global development and commercialization.

AstraZeneca's IMFINZI® (durvalumab) combined with chemotherapy shows significant improvement in event-free survival and overall survival for muscle-invasive bladder cancer (MIBC) in the NIAGARA Phase III trial. This trial demonstrated a notable reduction in disease recurrence and progression. Patients were treated with IMFINZI pre- and post-surgery, achieving better outcomes compared to chemotherapy alone. Approximately 117,000 MIBC patients are treated annually with standard care, which often leads to high recurrence rates. The IMFINZI regimen, well-tolerated with no new safety concerns, potentially transforms the standard of care for MIBC. Data will be presented at an upcoming medical meeting.

AstraZeneca’s IMFINZI® (durvalumab), in combination with chemotherapy, has received FDA approval for treating mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. This approval is based on the DUO-E Phase III trial, showing a 58% reduction in disease progression or death compared to chemotherapy alone. The trial results were published in the Journal of Clinical Oncology. Endometrial cancer is notably prevalent, with over 66,000 diagnoses and nearly 12,000 deaths in the US in 2022. Early-stage diagnosis boasts an 80-90% five-year survival rate, but advanced stages drop below 20%. The combination treatment is seen as a significant advancement in a field that has seen progress. The safety profile of IMFINZI combined with chemotherapy is considered manageable and consistent with previous trials. Further regulatory reviews are ongoing in the EU, Japan, and other countries.

AstraZeneca's ECHO Phase III trial revealed that CALQUENCE® (acalabrutinib) combined with bendamustine and rituximab significantly reduced the risk of disease progression or death by 27% in untreated mantle cell lymphoma (MCL) patients compared to standard chemoimmunotherapy. Median progression-free survival (PFS) was 66.4 months with CALQUENCE vs. 49.6 months with the standard treatment. The study demonstrated a favorable trend in overall survival (OS) but the data remains immature. Safety profiles were consistent with previous findings, and no new safety signals were identified. These results were presented at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid.