Benzinga - by Vandana Singh, Benzinga Editor.
On Wednesday, China approved AstraZeneca plc's (NYSE:AZN) Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy for the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer whose tumors have exon 19 deletions or exon 21 mutations.
On Tuesday, the Tagrisso with pemetrexed and platinum-based chemotherapy regime received approval in Japan for the same indication.
China's National Medical Products Administration approved the drug based on the results of the FLAURA2 Phase 3 trial, which were published in the New England Journal of Medicine.
In the overall trial population, Tagrisso, with the addition of chemotherapy, reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the 1st-line global standard of care.
Median progression-free survival (PFS) was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).
PFS results by blinded independent central review (BICR) in the overall trial population were consistent with results by investigator assessment, showing a median PFS of 29.4 months with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy (19.9 months).
While the overall survival (OS) remained immature at the second interim analysis (41% maturity), an encouraging trend towards an OS benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone. The trial continues to assess OS as a key secondary endpoint.
Efficacy results from the China cohort of FLAURA2 were broadly consistent with the overall trial.
By investigator assessment, Tagrisso, with the addition of chemotherapy reduced the risk of disease progression or death by 44% compared to Tagrisso monotherapy. Median PFS was 27.4 months for patients treated with Tagrisso plus chemotherapy, a 5.1-month improvement versus Tagrisso monotherapy (22.3 months).
PFS results in the China cohort by BICR were consistent with the results by investigator assessment, showing 33.2 months median PFS with Tagrisso plus chemotherapy, an 11.2-month improvement over Tagrisso monotherapy (22.0 months).
A trend towards an OS benefit was also observed in the China cohort for Tagrisso plus chemotherapy versus Tagrisso alone.
Price Action: AZN shares were trading lower by 0.92% to $79.02 at the last check on Wednesday.
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