No benefit of adding axitinib to ocreotide acetate in non-pancreatic neuroendocrine tumours

Adding axitinib to ocreotide acetate long-acting release to treat non-pancreatic neuroendocrine tumours (NETs) resulted in demonstrated activity with numerical clinical benefit, but did not reach significance, according to the results of a phase 2/3 study. Axitinib in this setting had a tolerable safety profile.

Dr Rocio Garcia-Carbonero (Hospital Universitario 12 de Octubre, Spain) presented the results of the randomised, double-blind phase 2 (n=106) and phase 3 (n=150) AXINET trial-GETNE-1107 (NCT01744249), which aimed to assess the efficacy of angiogenesis inhibitor axitinib in patients with advanced extra-pancreatic G1-G2 NETs.

Eligible patients (n=256; median age 61 years) were randomised to receive octreotide acetate long-acting release (30 mg every 4 weeks) with either axitinib (5 mg, twice daily; n=126) or placebo twice daily (n=130) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), time to progression, overall response rate (ORR), duration of response, biochemical response, and safety.

The primary endpoint was not met at this analysis; although median PFS favoured the axitinib arms, the difference did not reach statistical significance (17.2 vs 12.3 months; HR 0.816; P=0.169). However, ORR was significantly improved in axitinib- as opposed to placebo-treated patients (17.5% vs 3.8%; P=0.0004).

Adverse events occurred more frequently in the subjects receiving axitinib compared with placebo; grade 3-4 events occurred in 52% versus 13.8%, respectively. There were 3 treatment-related deaths, 1 in the axitinib arm (cardiac failure) and 2 in the placebo arm (myocardial infarction and hepatorenal syndrome).

1. Garcia-Carbonero R, et al. A phase II/III randomized double-blind study of octreotide acetate LAR with axitinib versus octreotide acetate LAR with placebo in patients with advanced G1-G2 NETs of non-pancreatic origin (AXINET trial-GETNE-1107). ASCO Gastrointestinal Cancers Symposium 2021, 15-17 January. Abstract 360.

 

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Posted on 12 March, 20214 April, 2024