Suresh Ramalingam, MD, principal investigator of the phase 3 LAURA trial, explains the study's evaluation of osimertinib in EGFR-mutated non-small cell lung cancer.
The phase 3 LAURA study (NCT03521154) investigated the effectiveness of osimertinib (Tagrisso) in patients with EGFR-mutated non-small cell lung cancer (NSCLC) after they received chemoradiotherapy (CRT) but the cancer hadn't progressed.
The LAURA trial randomly assigned patients to receive osimertinib or a placebo pill in a 2:1 ratio.
Osimertinib significantly improved progression-free survival compared to placebo. Patients taking osimertinib lived a median of 39.1 months without their cancer progressing compared to only 5.6 months for those on placebo. Osimertinib was well-tolerated with adverse effects mostly manageable.
These results suggest osimertinib should be considered the new standard treatment for this specific type of lung cancer after chemoradiotherapy.
Here, Suresh Ramalingam, MD, principal investigator of the phase 3 LAURA trial, and executive director of the Winship Cancer Institute of Emory University, explains the study's evaluation of osimertinib in EGFR-mutated NSCLC.
Transcription:
0:05 | We enrolled patients who had stage III disease with either EGFR exon 19 or 21 mutations, which are the 2 most common types of EGFR mutations, and these patients had completed chemotherapy and radiation. And as long as their cancer had not progressed, they were randomized to osimertinib or placebo. The primary endpoint was progression-free survival. And we're delighted to report that the median progression-free survival was substantially better for patients treated with osimertinib. It was 39.1 months compared to 5.6 months for patients in the placebo group. And the hazard ratio was 0.16, and it was statistically significant.
0:44 | We also found that the benefit was seen across all key subgroups of patients enrolled to the study. So it's widely applicable to this patient population, regardless of age, gender, specific type of mutation, where they come from, and so forth. We saw that the safety profile was consistent with what we would expect with either osimertinib alone and for patients who had recently completed chemoradiation therapy. So there were no undue safety signals. The survival results at this point are not mature; the data are awaited for full maturity, but we see a promising trend benefiting osimertinib. So overall, this trial, we believe will change the standard of care for this subset of patients.
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