(Lung Cancer) Osimertinib Monotherapy: What the Study Reported
(Lung Cancer) Osimertinib Monotherapy: What the Study Reported
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
(Lung Cancer) Osimertinib Monotherapy: What the Study Reported
- October 2, 2020
- 2 min read
On August 27, 2020, V.A. Papadimitrakopoulou published the article "Final Analysis of Efficacy and Safety of EGFR-targeted drug Monotherapy in the AURA3 Phase 3 Clinical Trial for Patients with EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer Who Progressed Following EGFR Tyrosine Kinase Inhibitor Treatment" in the medical journal Annals of Oncology.
The AURA3 Phase 3 clinical trial enrolled patients with EGFR T790M mutation-positive non-small cell lung cancer who had experienced disease progression following EGFR tyrosine kinase inhibitor treatment (N=415). Patients were randomized 2:1 into the following two groups, with the primary endpoint of progression-free survival and secondary endpoints of overall survival and safety.
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EGFR-targeted drug group (80 mg daily, N=279)
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Pemetrexed combination therapy group (pemetrexed + carboplatin or cisplatin, N=136)
In the final analysis of this trial, the median overall survival for the secondary endpoint was 26.8 months in the EGFR-targeted drug group vs. 22.5 months in the pemetrexed combination therapy group, with no statistically significant difference in overall survival risk. The 24-month overall survival rates were 55% for the EGFR-targeted drug group vs. 43% for the pemetrexed combination therapy group, and the 36-month overall survival rates were 37% for the EGFR-targeted drug group vs. 30% for the pemetrexed combination therapy group. After crossover treatment, the EGFR-targeted drug group showed a notable improvement.
Regarding safety, the most frequently observed adverse events in the EGFR-targeted drug group were diarrhea (32%) and skin disorders (32%). In the pemetrexed combination therapy group, the most common adverse event was nausea (47%).
Based on the final analysis results of the AURA3 clinical trial, V.A. Papadimitrakopoulou concluded: In patients with EGFR T790M mutation-positive non-small cell lung cancer who progressed following EGFR tyrosine kinase inhibitor treatment, there was no significant difference between the EGFR-targeted drug group and the pemetrexed combination therapy group; however, the benefit of crossover from the pemetrexed combination therapy group to the EGFR-targeted drug group was likely more pronounced.
[Disclaimer] The clinical trial data and pharmaceutical information translated by Medical Supporter are not intended to promote participation in clinical trials or the use of new drugs. The translated materials are for reference purposes only and do not constitute prescribing guidelines. Please consult your healthcare provider, and refer to the original text at the bottom of the article for accurate information.
Source: Osimertinib versus platinum-pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis (Ann Oncol. 2020 Aug 27;S0923-7534(20)42155-6. doi: 10.1016/j.annonc.2020.08.2100.)
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