AstraZeneca PLC - AZN STOCK NEWS

DATROWAY® (datopotamab deruxtecan-dlnk) has received FDA approval for treating adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy. The approval was based on the TROPION-Breast01 Phase III trial results, which showed a 37% reduction in the risk of disease progression or death compared to chemotherapy.

The trial demonstrated a median progression-free survival of 6.9 months for DATROWAY versus 4.9 months with chemotherapy. The safety profile was consistent with known data, with an interstitial lung disease rate of 4.2%, mostly low grade. This marks AstraZeneca's eighth new medicine of their targeted 20 medicines by 2030.

AstraZeneca's CALQUENCE (acalabrutinib) in combination with bendamustine and rituximab has received FDA approval for treating previously untreated mantle cell lymphoma (MCL) in adult patients ineligible for autologous stem cell transplantation. The approval was based on the ECHO Phase III trial results, which demonstrated a 27% reduction in disease progression or death risk compared to standard chemoimmunotherapy.

The trial showed median progression-free survival of 66.4 months for the CALQUENCE combination versus 49.6 months with chemoimmunotherapy alone. After censoring COVID-19 deaths, the risk reduction improved to 36%. This makes CALQUENCE the first and only BTK inhibitor approved for first-line MCL treatment in the US.

MCL is a rare and aggressive form of non-Hodgkin lymphoma, with over 21,000 patients diagnosed across major markets. The safety profile was consistent with known data, and no new safety signals were identified.

AstraZeneca and Daiichi Sankyo have received Priority Review from the FDA for datopotamab deruxtecan (Dato-DXd) in treating adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior therapies. The FDA decision is expected in Q3 2025.

The application is supported by data from multiple trials, including TROPION-Lung05, which showed a 42.7% objective response rate and a median duration of response of 7.0 months in previously treated patients. The drug previously received Breakthrough Therapy Designation for this indication.

If approved, datopotamab deruxtecan would become the first TROP2-directed antibody drug conjugate for lung cancer. The companies are currently conducting seven Phase III trials evaluating the drug alone and in combinations for NSCLC treatment.

AstraZeneca (AZN) and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) has received Priority Review status from the FDA for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior therapies. The FDA's decision date is set for July 12, 2025.

The application is supported by data from multiple clinical trials, including TROPION-Lung05 phase 2, TROPION-Lung01 phase 3, and TROPION-PanTumor01 phase 1. A pooled analysis presented at ESMO Asia 2024 showed clinically meaningful tumor response, with a safety profile consistent with previous reports.

Dato-DXd, a TROP2 directed antibody drug conjugate, could become the first of its kind approved for lung cancer. The drug is currently being evaluated in seven phase 3 trials, including combinations with osimertinib for EGFR-mutated nonsquamous NSCLC.

Asher Biotherapeutics has entered into a clinical supply agreement with AstraZeneca (AZN) for a global Phase 1b/2 study. The study will evaluate the combination of Asher Bio's etakafusp alfa (AB248) with AstraZeneca's rilvegostomig as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC).

Under the agreement, AstraZeneca will sponsor and conduct the global study, while Asher Bio will retain full ownership of etakafusp alfa and provide it at no cost. Initial Phase 1 data for etakafusp alfa has shown promising results, demonstrating selective CD8+ T cell activation and early evidence of anti-tumor effects, including confirmed objective responses.

AstraZeneca (AZN) and Daiichi Sankyo have voluntarily withdrawn their marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for treating advanced nonsquamous non-small cell lung cancer (NSCLC). The withdrawal follows feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use.

The companies remain committed to developing the drug for lung cancer patients through seven pivotal trials. Their separate application for datopotamab deruxtecan in hormone receptor positive, HER2 negative metastatic breast cancer remains under EU review.

Tracer Biotechnologies has announced a multi-year agreement with AstraZeneca (AZN) to implement its circulating tumor DNA (ctDNA) monitoring technology in clinical trials. The company's proprietary platform, based on digital PCR technology, offers a cost-effective and precise alternative to traditional radiographic imaging for cancer monitoring. The platform specializes in tumor-informed ctDNA detection, enabling more frequent and accurate assessment of treatment response and disease progression in cancer patients.

LYNPARZA (olaparib) demonstrated significant survival benefits in early breast cancer patients according to updated results from the OlympiA Phase III trial. At 6.1 years median follow-up, the drug reduced death risk by 28% versus placebo, with 87.5% of treated patients surviving compared to 83.2% in the placebo group.

The treatment showed sustained improvements in key endpoints: 35% reduction in invasive breast cancer recurrence, second cancers or death, and 35% reduction in distant disease recurrence or death. The benefits were consistent across all subgroups, including high-risk, hormone-receptor-positive disease patients.

LYNPARZA is the first and only PARP inhibitor approved for treating germline BRCA-mutated, HER2-negative high-risk early breast cancer. The safety profile remained consistent with previous trials, with no new safety signals identified.

Datopotamab deruxtecan (Dato-DXd) has received Breakthrough Therapy Designation (BTD) from the FDA for treating adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have experienced disease progression after EGFR-TKI and platinum-based chemotherapy treatments.

The designation is based on data from the TROPION-Lung05 Phase II trial and supported by the TROPION-Lung01 Phase III trial. This marks the first BTD for datopotamab deruxtecan, a TROP2-directed DXd antibody drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo. The companies have already submitted a Biologics License Application for accelerated approval in the US.