Tagrisso – First Precision Medicine Approved for Treatment of Early Stage NSCLC

MedMaven

by Dr. C.H. Weaver M.D. 4/2020

Early assessment from an Independent Data Monitoring Committee has recommended a pivotal clinical trial evaluating Tagrisso in early stage non-small cell lung cancer (NSCLC) be halted based on its determination of the effectiveness of Tagrisso to delay cancer progression. Clinical trials have demonstrated that chemotherapy delays cancer recurrence and prolongs survival when used to treat early stage NSCLC. The development of precision cancer medicines has allowed for more precise targeting of certain cancers which can spare individuals that won’t benefit from treatment the side effects associated with therapy. Now there is evidence that certain patients with early stage NSCLC can avoid chemotherapy and be treated with a targeted precision cancer medicine. (1,2)

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have epidermal growth factor receptor - mutated (EGFRm) NSCLC. (3,4,5) These patients are particularly sensitive to treatment with precision cancer medicines known as EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signaling pathways that drive the growth of EGFR expressing lung cancer cells.

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso is the standard of care for the treatment of EGFRm advanced NSCLC because it delays cancer progression and prolongs survival. It’s logical that it should be evaluated and demonstrate benefit in earlier stage cancers.

In the Phase III ADAURA clinical trial Tagrisso treatment for up to three years was compared to placebo as adjuvant therapy of patients with Stage IB, II and IIIA EGFRm NSCLC following complete cancer resection. The trial enrolled patients from more than 200 treatment centers across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East.

The primary endpoint of the trial was to determine whether Tagrissio could delay cancer progression and the preliminary analyses confirmed that it does. Patients on the trial will continue to be followed to determine if treatment improves overall survival as well, and a full report of the trial results will be presented at an upcoming medical meeting.

References

  1. LUNGevity Foundation. Types of Lung Cancer. Available at https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer.
  2. The International Adjuvant Lung Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected Non-Small Cell Lung Cancer. New England Journal of Medicine. 2004;350:351-360.
  3. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12.
  4. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.
  5. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89.
  6. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.
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