Monday, the FDA approved AstraZeneca Plc’s (NASDAQ: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.
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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:Â AZN shares are up 2.77% at $66.05 during the premarket session on the last check Monday.
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