Study: Post-Surgery Osimertinib Delays Disease Recurrence in Patients with Localized Non-Small Cell Lung Cancer

June 3, 2020
Jill Murphy, Assistant Editor

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor and is approved in the United States for first-line treatment of patients with metastatic NSCLC with tumors that have EGFR mutations (exon 19 deletions or exon 21 L858R mutations).

A recent phase 3 study presented during the virtual science program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting found that treatment with targeted therapy osimertinib (Tagrisso, AstraZeneca) following surgery for localized non-small lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation significantly improved disease-free survival.

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor and is approved in the United States for first-line treatment of patients with metastatic NSCLC with tumors that have EGFR mutations (exon 19 deletions or exon 21 L858R mutations). Results from this trial show efficacy in the adjuvant setting for patients with earlier stage disease and the same EGFR mutations.

Of patients with stage 2-3A NSCLC who received osimertinib, 90% were alive at 2 years without the cancer recurring, compared with 44% who received a placebo. In stage 2-3A patients, the risk of disease recurrence or death was reduced by 83% for patients treated with adjuvant osimertinib after surgery compared to placebo.

The trial included 682 patients with primary non-squamous stage 1B-3A NSCLC and confirmed EGFR mutation who were randomized to receive adjuvant osimertinib (339 patients) or placebo (343 patients).

Participants were included if they had complete resection of primary NSCLC with full recovery from surgery. The patients who received osimertinib took 80 mg tablets once daily for up to 3 years, and with postoperative chemotherapy allowed.

Baseline patient characteristics were balanced across arms. Thirty-one percent of patients in both groups had stage 1B disease, and 69% had stage 2/3A disease. More patients in both groups were female, with 68% and 72% in the osimertinib and placebo groups, respectively.

“This trial is a home run. It exceeded our expectations,” said lead author Roy S. Herbst, MD, PhD, in a press release. “It’s an important advance to see a targeted therapy significantly delay disease recurrence following surgery in patients with non-small cell lung cancer. We can now treat patients earlier.”

REFERENCE

Post-surgery osimertinib delays disease recurrence in patients with localized non-small cell lung cancer [news release]. Alexandria, VA; ASCO: May 28, 2020. https://www.asco.org/about-asco/press-center/news-releases/post-surgery-osimertinib-delays-disease-recurrence-patients. Accessed June 2, 2020.