Osimertinib confers lasting DFS benefit in resected EGFR-mutant non-small cell lung cancer
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Key takeaways:
- Patients who received osimertinib had a sustained clinically meaningful DFS benefit compared with those who received placebo.
- Osimertinib also reduced risk for local and distant recurrence.
Osimertinib extended DFS and reduced risk for recurrence among patients with resected EGFR-mutated non-small cell lung cancer, according to an updated analysis of data from the phase 3 ADAURA trial published in Journal of Clinical Oncology.
The findings also showed no new safety concerns with osimertinib (Tagrisso, AstraZeneca), researchers wrote.
Rationale and methodology
“It has always been our goal to move the most active targeted therapies up to treat the earliest stages of lung cancer,” Roy S. Herbst, MD, PhD, Ensign professor of medicine and pharmacology and deputy director at Yale Cancer Center, told Healio. “This trial added the third-generation EGFR-targeted agent osimertinib to the adjuvant treatment of [patients with EGFR-positive NSCLC],” Herbst said.
As Healio previously reported, the double-blind, randomized, placebo-controlled ADAURA trial aimed to assess the safety and efficacy of adjuvant osimertinib among 682 patients with EGFR-mutated NSCLC after complete tumor resection.
Researchers assigned patients to 80 mg once daily osimertinib or placebo for up to 3 years.
Investigator-assessed DFS among patients with stage II to stage IIIA disease served as the primary endpoint. Secondary endpoints included DFS among those with stage IB to stage IIIA disease, OS and safety. Researchers also examined patterns of recurrence and central nervous system DFS as prespecified exploratory endpoints.
Herbst and colleagues reported updated analyses of final DFS data, recurrence risk and long-term safety. Median follow-up was 44.2 months in the osimertinib group and 19.6 months in the placebo group.
Findings
Results showed a prolonged DFS benefit with adjuvant osimertinib (HR = 0.23; 95% CI, 0.18-0.3) and higher 4-year DFS rate vs. placebo (70% vs. 29%) among those with stage II to stage IIIA disease.
Among the overall study population, researchers observed a DFS HR of 0.27 (95% CI, 0.21-0.34) and 4-year DFS rates of 73% with osimertinib and 38% with placebo. The osimertinib group had lower rates of disease recurrence (27% vs. 60%), including local/regional (12% vs. 23%), distant (13% vs. 31%) and local/regional and distant (13% vs. 31%) recurrence.
Researchers additionally observed CNS DFS HR of 0.24 (95% CI, 0.14-0.42).
Long-term safety appeared consistent with previously published data, and researchers identified no new safety concerns.
Implications
“This confirms the use of osimertinib as an adjuvant therapy, which is already a standard of care in many countries,” Herbst told Healio. “We are now awaiting further maturity of the trial and survival results, which are expected within the next year.”
For more information:
Roy S. Herbst, MD, PhD, can be reached at roy.herbst@yale.edu.
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