AstraZeneca announced that it has received marketing authorisation from China's National Medical Products Administration (NMPA) for Tagrisso (osimertinib) as a 1st-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions.
The approval followed the Priority Review Pathway and is based on results from the Phase III FLAURA trial, which were published in The New England Journal of Medicine.
Dave Fredrickson, Executive Vice President, Oncology, said: "The FLAURA trial has demonstrated the potential of Tagrisso as a new standard of care and as an important new 1st-line treatment option for non-small cell lung cancer patients in China, where approximately 30-40% are diagnosed with an EGFR mutation – more than any other country in the world."
In the FLAURA trial, 1st-line use of Tagrisso provided a statistically-significant and clinically- meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death by a median of 18.9 months versus 10.2 months for those taking standard EGFR tyrosine kinase inhibitor (TKI) medicines (HR 0.46 [95% CI, 0.37-0.57], p<0.0001). This benefit was consistent across all patient subgroups including those with central nervous system (CNS) metastases.
AstraZeneca recently announced that Tagrisso additionally showed a statistically-significant and clinically-meaningful improvement in overall survival in this patient population.
Safety data for Tagrisso in the FLAURA trial were in line with those observed in prior clinical trials. Tagrisso was generally well tolerated, with Grade 3 or higher adverse events (AEs) occurring in 34% of patients taking Tagrisso versus 45% in the comparator arm. The most common AEs in patients treated with Tagrisso were diarrhoea (58%), rash (58%), dry skin (36%), nail toxicity (35%), stomatitis (29%), fatigue (21%) and decreased appetite (20%).
Tagrisso was approved in China in March 2017 and added to the National Reimbursement Drug List (NRDL) effective from January 2019 for the 2nd-line treatment of adult patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed on or after EGFR-TKI therapy.
About lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined.(1) Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% classified as NSCLC.(2) Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated (EGFRm) NSCLC.(3-5) These patients are particularly sensitive to treatment with EGFR-TKIs which block the cell-signalling pathways that drive the growth of tumour cells. Approximately 25% of patients with EGFRm NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.(6) The presence of brain metastases often reduces median survival to less than eight months in patients not treated with Tagrisso.(7)
About Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.
Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in 75 countries, including the US, Japan, China and the EU, for 1st-line EGFRm advanced NSCLC, and in 84 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the adjuvant setting (ADAURA trial), in the locally-advanced unresectable setting (LAURA), in combination with chemotherapy in the advanced setting (FLAURA2), and with potential new medicines, including savolitinib in the Phase II trials SAVANNAH and ORCHARD.
About FLAURA
The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg orally once daily vs. comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patien...
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