Results from CLARINET study presented at ESMO (IPSEN, 28 September 2013)

The final analysis of data from the phase III trial has demonstrated lanreotide significantly prolonged progression-free survival in patients with gastroenteropancreatic (GEP) neuroendocrine tumours (NETs) compared to treatment with placebo.

The patients were randomised to receive either 120 mg lanreotide Autogel (n=101) or placebo (n=103) every 4 weeks for 96 weeks or until progressive disease (PD) or death. The trial’s primary endpoint was progression-free survival (PFS) by RECIST criteria. Secondary endpoints were the percentage of patients who died or showed PD and safety. At enrolment, primary tumour locations were pancreas (44%), midgut (36%), hindgut (7%) and unknown (13%). Most patients had stable tumours (96%) and were treatment-naïve (84%). 30% of patients had Ki67 3%–10% (WHO grade 2), 33% had hepatic tumour load >25%.

The trial met both primary and secondary endpoints. At a time-point of two years following initiation of treatment, median PFS was not reached with lanreotide compared to 18 months with placebo, hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.30, 0.73 (p = 0.0002). Neither disease progression nor death occurred in 62% of lanreotide patients compared to 22% of placebo patients.

The safety results showed lanreotide had favourable safety and tolerability that was consistent with its known safety profile. Treatment-related adverse events (AEs) occurred in 50% of patients receiving lanreotide and 28% of placebo patients, with diarrhea being the most frequently reported AE in 26% versus 9% of patients receiving lanreotide and placebo, respectively. Serious AEs were reported in 3% patients receiving lanreotide and in 1% of placebo patients.

Source: IPSEN (press release)