Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca (AZN) and Daiichi Sankyo have voluntarily withdrawn their marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for treating advanced nonsquamous non-small cell lung cancer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.

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 tyrosine kinase inhibitor and platinum-based chemotherapy treatments.

The BTD, which aims to accelerate development and regulatory review of promising medicines, was granted based on data from the TROPION-Lung05 phase 2 trial and supporting data from the TROPION-Lung01 phase 3 trial. This marks the first BTD for datopotamab deruxtecan and the twelfth BTD across Daiichi Sankyo's oncology pipeline.

Daiichi Sankyo and AstraZeneca have submitted a new Biologics License Application for accelerated approval in the U.S. for this treatment.

AstraZeneca's CALQUENCE demonstrated significant results in the AMPLIFY Phase III trial for previously untreated chronic lymphocytic leukemia (CLL). When combined with venetoclax, it reduced disease progression or death risk by 35% compared to standard chemoimmunotherapy. Adding obinutuzumab further improved results, showing a 58% risk reduction.

At 36 months, progression-free survival rates were 76.5% for CALQUENCE plus venetoclax and 83.1% with obinutuzumab addition, versus 66.5% for standard care. Overall response rates exceeded 92% in both CALQUENCE arms compared to 75.2% for standard treatment. The safety profile was consistent with known data, with no new safety signals identified.

AstraZeneca's IMFINZI® (durvalumab) has received Priority Review from the FDA for treating muscle-invasive bladder cancer (MIBC). The decision is based on the NIAGARA Phase III trial results, which showed significant improvements in event-free and overall survival. The trial demonstrated a 32% reduction in disease progression risk and a 25% reduction in death risk with IMFINZI compared to standard treatment.

The treatment involves IMFINZI combined with neoadjuvant chemotherapy before radical cystectomy, followed by IMFINZI monotherapy. At two years, 67.8% of IMFINZI-treated patients were event-free compared to 59.8% in the control group, and 82.2% were alive versus 75.2% in the control group. If approved, this would be the first perioperative immunotherapy regimen in this setting.

Datopotamab deruxtecan demonstrated significant clinical activity in a pooled analysis of TROPION-Lung05 and TROPION-Lung01 trials for previously treated EGFR-mutated non-small cell lung cancer (NSCLC) patients. The analysis showed a 42.7% objective response rate in 117 patients, with a median duration of response of 7.0 months and disease control rate of 86.3%.

The drug showed similar efficacy in patients previously treated with osimertinib, achieving a 44.8% objective response rate in 96 patients. The safety profile remained consistent with previous reports, with stomatitis, alopecia, and nausea being the most common treatment-related adverse events.

AstraZeneca's IMFINZI has received FDA approval as the first and only immunotherapy for -stage small cell lung cancer (LS-SCLC) patients whose disease hasn't progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval is based on the ADRIATIC Phase III trial results, which demonstrated:

- 27% reduction in death risk versus placebo
- Median overall survival of 55.9 months vs 33.4 months for placebo
- 57% of IMFINZI-treated patients survived at three years vs 48% for placebo
- 24% reduction in disease progression or death risk
- Median progression-free survival of 16.6 months vs 9.2 months for placebo

The safety profile was manageable and consistent with known effects, with no new safety signals observed.