Icotinib Tops Chemo as Adjuvant Therapy for EGFR-Mutant NSCLC

By Reuters Staff

August 13, 2021

NEW YORK (Reuters Health) — Following complete resection of EGFR-mutant stage-II to -IIIA non-small-cell lung cancer (NSCLC), icotinib significantly improves disease-free survival and has fewer side effects than chemotherapy, according to interim results of a phase-3 trial underway in China.

Icotinib (Betta Pharmaceuticals) is a highly selective, first-generation EGFR tyrosine kinase inhibitor (TKI) approved in China as first-line monotherapy in patients with NSCLC with somatic EGFR mutations.

With the EVIDENCE trial, Dr. Jianxing He with The First Affiliated Hospital of Guangzhou Medical University and colleagues are testing icotinib versus chemotherapy as adjuvant treatment in 322 patients with completely resected stage-II to -IIIA EGFR-mutant NSCLC.

Half were randomly allocated to oral icotinib 125 mg thrice daily for two years and half to four 21-day cycles of intravenous chemotherapy (vinorelbine plus cisplatin for adenocarcinoma or squamous carcinoma; or pemetrexed plus cisplatin for non-squamous carcinoma).

In their Lancet Respiratory Medicine paper, the researchers report results for 151 patients in the icotinib group and 132 in the chemotherapy group, followed for a median of 24.9 months. During this time, 40 (26%) patients in the icotinib group and 58 (44%) in the chemotherapy group died or had disease relapse.

Median disease-free survival (primary endpoint) was significantly longer with adjuvant icotinib than standard chemotherapy (47.0 months vs. 22.1 months; stratified hazard ratio, 0.36; P < .0001).

Three-year disease-free survival was 63.9% in the icotinib group versus 32.5% in the chemotherapy group. Overall survival data are immature, the researchers note, but with "longer follow-up, we will be able to determine if adjuvant use of icotinib can also improve overall survival in the patient population."

Treatment-related serious adverse events were less common with icotinib than chemotherapy. No patient in either group developed interstitial pneumonia or died from a treatment-related side effect.

These interim results suggest "clinical potential for adjuvant icotinib in stage II-IIIA NSCLC with a better tolerance profile than chemotherapy."

"Our study also suggests that EGFR-TKI therapy could be an appropriate adjuvant therapy in patients with resected EGFR-mutant NSCLC. However, our trial requires further follow-up to observe whether the prolonged disease-free survival translates into a significant overall survival benefit," they caution.

Betta Pharmaceuticals funded the study. Two authors are employees of the company.

SOURCE: https://bit.ly/3rJwDUZ The Lancet Respiratory Medicine, online July 16, 2021.

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