Astrazeneca Plc Stock Price, News & Analysis

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.

AstraZeneca's FARXIGA® (dapagliflozin) has received FDA approval for glycemic control in pediatric patients aged 10 years and older with type-2 diabetes (T2D). This approval is based on positive results from the T2NOW Phase III trial, which showed significant A1C reductions compared to placebo (-0.62% for FARXIGA vs. +0.41% for placebo). The approval extends the previously approved use of FARXIGA in adults as an adjunct to diet and exercise.

FARXIGA demonstrated a well-characterized safety profile consistent with adult studies and is now approved in 126 countries, including the EU. AstraZeneca emphasizes this approval as a milestone for pediatric T2D patients, addressing the rising incidence of T2D in children and adolescents, who often face earlier and faster disease progression compared to adults.

AstraZeneca's supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has received Priority Review from the FDA for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) post-chemoradiotherapy. The decision is based on the LAURA Phase III trial, which indicated a significant extension in median progression-free survival (PFS) of more than three years. TAGRISSO was also granted Breakthrough Therapy Designation for this setting. The FDA action date is anticipated in Q4 2024. TAGRISSO showed an 84% reduction in the risk of disease progression or death compared to placebo, with a PFS of 39.1 months versus 5.6 months with placebo. Safety profiles were consistent with no new concerns identified. Additionally, TAGRISSO is approved in over 100 countries for various indications in treating EGFR-mutated NSCLC.