Icotinib matches gefitinib in NSCLC second or third line

Sep 26 2013

By Stephanie Leveene, medwireNews Reporter

Icotinib has been found to be noninferior to gefitinib in patients with non-small-cell lung cancer (NSCLC), according to reports from the phase III Chinese double-blind ICOGEN study.

“[I]cotinib is a valid therapeutic option for patients with non-small-cell lung cancer as a second-line or third-line treatment, although patients might find taking icotinib three times a day an inconvenience,” write Yan Sun (Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China) and colleagues.

Icotinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that has exhibited good antitumor activity in phase II studies. However, it has a shorter half-life than gefitinib, another TKI, which means that it needs to be taken more often.

For the study, 399 patients with metastatic or locally advanced NSCLC refractory to platinum-based chemotherapy were randomly assigned to receive either icotinib 125 mg three times daily or gefitinib 250 mg once daily.

As reported in TheLancet Oncology, treatment with icotinib was noninferior to gefitinib in terms of the primary endpoint of median progression-free survival (PFS; 4.6 vs 3.4 months). In general, patients with EGFR mutations had significantly longer median PFS than patients with wild-type EGFR (6.3 months vs 2.3 months). However, there was no significant difference when those with EGFR mutations and wild-type EGFR were considered separately.

There were also no significant differences between patients taking icotinib and those taking gefitinib in terms of time to progression or overall survival. The most common adverse events overall were rash, diarrhea, pain, and raised aminotransferase levels; the rates of each were about the same for the two treatment groups.

Sun and team note that ICOGEN was the first head-to-head, phase III trial of two molecularly targeted agents in pretreated patients with NSCLC, but the results “are consistent with those of other randomised studies in patients with non-small-cell lung cancer taking TKIs in a similar clinical setting.”

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