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Updated analysis from the phase 3 ADAURA trial: no significant changes in Osimertinib’s safety profile in non–small cell lung cancer since the primary analysis


An updated analysis of the phase 3 ADAURA trial did not find any new safety signals and no deterioration in health-related quality of life ( HRQOL ) following treatment with Osimertinib ( Tagrisso ) among patients with resected, stage IB to IIIA, EGFR-mutant non-small cell lung cancer ( NSCLC ).

Adverse events leading to dose reductions were reported in 12% of patients receiving Osimertinib in this updated analysis, which was consistent with the rate of 9% that read out in the primary analysis.
Adverse effects leading to dose interruption occurred in 27% of patients in the updated analysis and 24% in the primary analysis, and adverse reactions leading to discontinuation occurred in 13% and 11%, respectively.

In this updated analysis, the most common adverse effects leading to dose reductions were: stomatitis ( 3% ), diarrhea ( 2% ), and paronychia ( 2% ).
Dose interruptions were most commonly attributed to diarrhea ( 4% ) and stomatitis ( 2% ), and discontinuation was most commonly due to interstitial lung disease ( 2% ).

Investigators assessed health-related quality of life ( HRQOL ) using Short Form-36 surveys. Physical component summary mean absolute T-scores ranged from 47 to 50 points with Osimertinib versus 46 to 50 with placebo, and mental component summary mean absolute T-scores ranged from 43 to 50 points with Osimertinib versus 44 to 51 with placebo.
The differences in these mean HRQOL scores between the Osimertinib and placebo groups never exceeded 1.5 points, including at treatment discontinuation visits.

The updated analysis assessed toxicities and quality of life across all 682 patients enrolled in ADAURA, who were randomly assigned 1:1 in the period 2015-2019 to receive either 80 mg of Osimertinib ( n = 339 ) or placebo ( n = 343 ) once daily.
As of data cutoff ( april 2022 ), all patients in the placebo group had received at least 1 dose of treatment, and the same was true of 337 patients in the Osimertinib group.

Overall, 66% of those in the Osimertinib group completed the planned 3 years of treatment compared with 41% in the placebo group. The median total duration of treatment exposure was 35.8 months with Osimertinib ( range, 0-38 ) versus 25.1 months with placebo ( range, 0-39 ), and the median actual durations of exposure were 35.4 ( range 0-38 ) and 25.1 ( 0-39 ) months, respectively.

The primary end point was disease-free survival ( DFS ) as assessed by investigators, and key secondary end points included safety and HRQOL.

The most common adverse events related to Osimertinib were diarrhea ( 40% ), paronychia ( 25% ), and dry skin ( 22% ).

There was a single death caused by adverse effects in the Osimertinib group resulting from respiratory failure, and 2 such deaths in the placebo group resulting from an instance of pulmonary embolism and another of an unknown fatal event.
Researchers found none of these adverse reaction to be related to the study regimens. ( Xagena )

John T et al, J Thorac Oncol 2023;18(9):1209-1221

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