AstraZeneca’s Tagrisso Hits The OS Mark In Phase III Lung Cancer Trial

Shares of AstraZeneca are climbing this morning after the company announced its Phase III lung cancer trial showed a statistically-significant benefit in overall survival in previously untreated patients whose tumors have epidermal growth factor receptor (EGFR) mutations.

U.K.-based AstraZeneca said Tagrisso (osimertinib) hit the mark when compared to first-line treatments gefitinib (Iressa) and erlotinib (Tarceva), both EGFR tyrosine kinase inhibitors. Tagrisso, a third-generation inhibitor of both EGFR and tyrosine kinase, showed both statistically-significant and clinically-meaningful benefit in overall survival, which was a secondary endpoint in the Phase III trial.

Two years ago, in 2017, Tagrisso, a third-generation inhibitor of both EGFR and tyrosine kinase, showed both statistically-significant and clinically-meaningful benefit in progression-free survival in patients who were diagnosed with non-small cell lung cancer (NSCLC) who were locally-advanced or metastatic epidermal growth factor receptor mutation-positive. The safety and tolerability of Tagrisso were consistent with its established profile.

José Baselga, AstraZeneca’s head of oncology research and development said the overall survival results show that Tagrisso “provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors.” Baselga said the results of the trial reaffirmed Tagrisso as the “first-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer.”

AstraZeneca plans to present the overall survival results from the FLAURA trial at a forthcoming medical meeting.

The FLAURA trial assessed the efficacy and safety of Tagrisso in previously untreated patients with locally advanced or metastatic EGFR mutation-positive NSCLC. Tagrisso is currently approved in more than 74 countries, including the U.S., Japan and the European Union, as a first-line treatment for EGFR-mutated metastatic NSCLC.

Lung cancer is the leading cause of cancer-related deaths across the globe. Approximately 10-15% of patients in the U.S. and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. AstraZeneca noted that these patients are “particularly sensitive to treatment with currently-available EGFR-TKIs.” The company said tumors “almost always” develop a resistance to EGFR-TKI- specific treatment leading to disease progression. While approximately half of these patients develop EGFR T790M, a resistance mutation, Tagrisso targets this mutation that leads to disease progression, AstraZeneca noted. Tagrisso has been approved for patients with EGFR T790M mutation-positive advanced NSCLC. It is also under investigation investigated in the adjuvant and metastatic first-line settings. – Bio Space

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