European Drug Regulator Approves AstraZeneca's Two Flagship Cancer Drugs For Breast And Lung Cancer Settings

The European Commission on Friday approved AstraZeneca Plc AZN and Daiichi Sankyo's DSKNY Enhertu (trastuzumab deruxtecan) as a monotherapy for a type of breast cancer.

The approval covers adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.

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The approval is based on results from the DESTINY-Breast06 Phase 3 trial.

In the trial, Enhertu showed a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with chemotherapy-naïve HR-positive, HER2-low metastatic breast cancer with a median progression-free survival (PFS) of 13.2 months versus 8.1 months.

In the overall trial population, the median PFS was 13.2 months in patients randomized to Enhertu compared to 8.1 months in those randomized to chemotherapy.

In an exploratory analysis, results were consistent between patients with HER2-low expression and HER2-ultralow expression.

Following this approval for Enhertu in the EU, AstraZeneca is due to Daiichi Sankyo $125 million as a milestone payment.

The European Commission also approved AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy for adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.

Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death versus neoadjuvant chemotherapy alone in patients treated with the Imfinzi-based perioperative regimen.

In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone.

Additionally, interim overall survival (OS) results showed a favorable trend with the Imfinzi-based perioperative regimen. The OS data were not tested for statistical significance in this interim analysis and will continue to be assessed as a key secondary endpoint in the final analysis.

Price Action: AZN stock is down 6.37% at $69.21 at the last check on Friday.

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