Researchers involved in a multicenter trial have reported that Axitinib (AG-01376) has significant single agent activity in patients with advanced non-small cell lung cancer(NSCLC). The details of this Phase II trial were presented at the 2007 meeting of the American Society of Clinical Oncology.

Axitinib is an oral and selective inhibitor of VEGFR 1, 2, 3 that has shown activity in breast, thyroid and possibly pancreatic cancer. An open-label, multi-center Phase II study evaluated the efficacy and safety of axitinib in 32 patients with advanced NSCLC, 72 % of whom had received prior chemotherapy and half had received prior radiotherapy, 56% of patients were male. The majority of patients (75%) had adenocarcinoma. An objective response was observed in 3 patients (9%) and the median duration of survival was 12.8 months. Median progression-free survival was 5.8 months. eighty one percent of patients had treatment discontinued due to lack of effectiveness. These researchers concluded that axitinib demonstrated activity as a single agent.  Axitinib appeared to be well-tolerated in this population. The most common adverse events were fatigue, anorexia, diarrhea and hypertension.

Comments: Axitinib is an additional anti-angiogenesis agent which may have activity for the treatment of NSCLC.

Reference: Schiller JH, Larson T, OU SI, et al. Efficacy and safety of Axitinib (AG-013736;AG) in patients (pts) with advanced non-small cell lung cancer (NSCLC): A Phase II trial. Proceedings from the American Society of Clinical Oncology Conference. Chicago/IL. 2007. Abstract # 7507.

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