Why AstraZeneca Stock Is Trading Higher Tuesday

Monday, the FDA approved AstraZeneca Plc's AZN Tagrisso (osimertinib) plus chemotherapy for locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

• The approval following an FDA Priority Review was based on the results from the FLAURA2 Phase 3 trial published in The New England Journal of Medicine. 
•  Tagrisso, with the addition of chemotherapy, reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, which is the 1st-line global standard of care.
•  Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).
•  PFS results from blinded independent central review were consistent with the results by investigator assessment, showing 29.4 months median PFS with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy (19.9 months).
•  While the overall survival (OS) results remained immature at the second interim analysis (41% maturity), no trend towards a detriment was observed. The trial continues to assess OS as a key secondary endpoint.

Also Read: This Analyst Slightly Lowers AstraZeneca Forecast Amid Earnings Concerns, Although Still Bullish on Future Growth Potential

Concurrently, AstraZeneca released topline data from the LAURA Phase 3 trial of Tagrisso in Stage III EGFRm NSCLC after chemoradiotherapy (CRT) compared to placebo after CRT.

• The data showed that Tagrisso demonstrated a statistically significant and clinically meaningful improvement in PFS.
•  The OS data showed a favorable trend for Tagrisso, although data were not mature at the time of this analysis. The trial will continue to assess OS as a secondary endpoint.

The FDA also accepted AstraZeneca and Daiichi Sankyo's marketing application for datopotamab deruxtecan (Dato-DXd) for adult patients with locally advanced or metastatic nonsquamous NSCLC who have received prior systemic therapy. 

• The Prescription Drug User Fee Act date is during the fourth quarter of 2024.
•  The application is based on results from the pivotal TROPION-Lung01 Phase 3 trial in which datopotamab deruxtecan demonstrated a statistically significant improvement for the dual primary endpoint of PFS compared to docetaxel, the current standard of care. 
•  For the dual primary endpoint of OS, interim results numerically favored datopotamab deruxtecan over docetaxel in the overall population; however, results did not reach statistical significance at the time of data cut-off. 
•  In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favorable OS trend. The trial is ongoing, and OS will be assessed at the final analysis.

Price Action: AZN shares are up 2.77% at $66.05 during the premarket session on the last check Monday.

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