AstraZeneca today 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.
Phase III FLAURA trial efficacy results according to investigator assessment
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Tagrisso (N=279) |
EGFR TKI (gefitinib or erlotinib) (N=277) |
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Progression-free survival |
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Median PFS (95% confidence interval [CI]) |
18.9 months (15.2, 21.4) |
10.2 months (9.6, 11.1) |
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Hazard ratio (95% CI) |
0.46 (0.37-0.57) |
|
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P-value |
P<0.0001 |
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Response rate* |
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Overall response rate* (95% CI) |
77% (71, 82) |
69% (63, 74) |
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Complete response |
2% |
1% |
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Partial response |
75% |
68% |
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Duration of response (DoR)* |
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Median DoR (95% CI) |
17.6 months (13.8, 22.0) |
9.6 months (8.3, 11.1) |
*Confirmed responses.
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.