(Lung Cancer) Tagrisso as Post-Surgical Adjuvant Therapy?

• June 12, 2020
• Read time: 2 minutes

From May 29–31, 2020, Roy S. Herbst presented at the ASCO 2020 Virtual Meeting "Efficacy and safety results of EGFR inhibitor Tagrisso (osimertinib) as post-surgical adjuvant therapy in EGFR-mutant non-small cell lung cancer patients in the ADAURA Phase 3 clinical trial."

The ADAURA clinical trial was conducted across multiple international centers, randomizing EGFR-mutant non-small cell lung cancer patients (Stage IB/II/IIIA, N=682) in a 1:1 ratio into the following two groups. The primary endpoint was disease-free survival, and secondary endpoints were overall survival and safety:

1. Tagrisso group (once-daily Tagrisso 80 mg, N=339).
2. Placebo group (N=343).

Approximately 30% of non-small cell lung cancer patients are Stage I–IIIA, with surgery as the current standard treatment. Stage IB–III patients undergo post-surgical chemotherapy; however, the current standard post-surgical treatment has a relatively high recurrence rate, creating a need for new treatment approaches. The ADAURA clinical trial was initiated to investigate the efficacy of Tagrisso as post-surgical adjuvant therapy for EGFR-mutant non-small cell lung cancer patients.

Trial results were as follows. The primary endpoint disease-free survival showed that 2-year disease-free survival for Stage II–IIIA patients was: Tagrisso group 90% / placebo group 44% — significant improvement. Additionally, including Stage IB, 2-year disease-free survival was: Tagrisso group 89% / placebo group 53% — significant improvement.

Secondary endpoint overall survival: neither group had reached it (29 total deaths: Tagrisso group 9 / placebo group 20). Regarding safety, the adverse events that occurred with Tagrisso in this trial were consistent with those confirmed in other known clinical trials; no new adverse events were identified.

Based on the ADAURA trial results, Roy S. Herbst concluded: In EGFR-mutant non-small cell lung cancer patients, EGFR inhibitor Tagrisso used as post-surgical adjuvant therapy demonstrated improvement in disease-free survival compared to placebo, and is expected to become a new treatment option for such patients.

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Source: Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA. (2020 ASCO Virtual Scientific Program, Abstract No: LBA5)

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