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  • For patients with advanced non-small cell lung cancer and a mutation in the epidermal

  • growth factor receptor (or EGFR), first line treatment is with an EGFR tyrosine kinase

  • inhibitor (an EGFR-TKI).

  • Some patients initially have a good response to this treatment but over time the cancer

  • progresses in most.

  • In up to 60% of patients who have a recurrence of lung cancer, a point mutation in the gene

  • coding region T790M has been identified.

  • The presence of this mutation is associated with reduced binding of the EGFR TKI therapy

  • to the receptor, leading to less inhibition and to cancer progression.

  • Osimertinib is an oral, irreversible EGFR-TKI that is selective for both EGFR and T790M

  • resistance variants with activity against metastases to the central nervous system.

  • The international, open-label, AURA3 trial included 419 patients with T790M-positive

  • advanced non-small cell lung cancer, who had progression of cancer after prior treatment

  • with EGFR-TKI therapy.

  • 144 of the patients (34%) had asymptomatic brain metastases.

  • Patients were randomized to receive a daily dose of osimertinib or intravenous platinum-pemetrexed

  • chemotherapy every three weeks for 6 cycles, followed by maintenance pemetrexed.

  • The primary endpoint was investigator-assessed median progression-free survival, which was

  • 10.1 months in the osimertinib group, as compared with 4.4 months among those treated with IV

  • chemotherapy.

  • The hazard ratio, 0.30 was statistically significant.

  • A subgroup analysis of the patients with CNS metastases showed a median progression-free

  • survival of 8.5 months in the osimertinib group, as compared with 4.2 months in the

  • IV chemotherapy group.

  • Patients in the osimertinib group had diarrhea, rash and dry skin.

  • Cases of severe myelotoxicity were less common with osimertinib than with IV chemotherapy.

  • The authors conclude that in patients with T790M-positive advanced non-small cell lung

  • cancer and prior EGFR-TKI therapy, treatment with osimertinib resulted in significantly

  • longer progression-free survival than did IV platinum-pemetrexed chemotherapy.

  • Full trial results are available at NEJM.org.

For patients with advanced non-small cell lung cancer and a mutation in the epidermal

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