13 Jun ASCO20: TAGRISSO® (osimertinib) as Adjuvant Therapy for EGFRm Non-Small Cell Lung Cancer

MedicalResearch.com Interview with:

Dr. Herbst

Roy S. Herbst, MD, PhD
Ensign Professor of Medicine (Medical Oncology)
Professor of Pharmacology
Chief of Medical Oncology, Yale Cancer Center and
Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research
Yale Cancer Center

MedicalResearch.com: What is the background for this study? What are the main findings?

• ADAURA is the first global trial for an EGFR tyrosine kinase inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of Stage IB, II, and IIIA EGFRm NSCLC.
  The results demonstrated unprecedented disease free survival (DFS) in the adjuvant treatment of these patients after complete tumor resection with curative intent. Osimertinib was assessed against placebo for a treatment duration of up to three years and then unblinded two years earlier than expected at the recommendation of the Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy during a planned safety analysis.
• In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant (after surgery) treatment with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).
• DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).

MedicalResearch.com: What should readers take away from your report?

Response: Osimertinib is the only EGFR tyrosine kinase inhibitor in a global randomized, controlled trial to show a statistically significant and clinically meaningful benefit in this adjuvant setting, where rates of recurrence are high even after successful surgery and subsequent treatment with adjuvant chemotherapy. These results demonstrate for the first time in a global randomized, controlled trial that an EGFR-TKI may change the course of early-stage EGFR-mutated NSCLC and provide hope for a cure. 

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: The Phase III ADAURA trial will continue to assess overall survival, which is event driven, as a secondary endpoint. Data are expected in early 2023.

MedicalResearch.com: Is there anything else you would like to add? 

Response: These data are transformative for patients with early-stage EGFRm NSCLC who face high rates of recurrence even after successful surgery and subsequent treatment with adjuvant chemotherapy. Osimertinib may provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting.

• • Dr. Herbst’s disclosure is his consultant role for AstraZeneca. 

Citation:

Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA.

Roy S. Herbst, Masahiro Tsuboi, Thomas John, Christian Grohé, Margarita Majem, Jonathan Wade Goldman, Sang-We Kim, Dominika Marmol, Yuri Rukazenkov, and Yi-Long Wu

Journal of Clinical Oncology 2020 38:18_suppl, LBA5-LBA5

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Last Updated on June 13, 2020 by Marie Benz MD FAAD