NETTER-1 data shows improved PFS with Lutathera in neuroendocrine tumours.- Novartis.

Novartis announced presentation of a new analysis of Lutathera (lutetium Lu 177 dotatate) NETTER-1 data examining the impact of Lutathera treatment on patients with low, medium or high liver tumor burden. The data show that Lutathera treatment results in significant improvement in progression free survival (PFS) regardless of the extent of baseline liver tumor burden (LTB), elevated alkaline phosphatase (ALP) liver enzyme or presence of large (larger than 30mm diameter) lesion in patients with progressive midgut neuroendocrine tumors (NETs) compared to octreotide LAR alone. Liver tumor burden (LTB) was defined as tumor volume/total liver volume by CT or MRI, and categorized as low (below 25%), moderate (25-50%), and high (more than 50%). Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone was 28.35 vs 11.04 in low; Not Reached (NR) vs 8.67 in moderate; 19.38 vs 5.52 in high LTB respectively. Because the numbers of patients and events of deteriorations are small for the moderate and high liver burden groups for quality of life assessments, moderate/high liver burden groups were pooled into one group. Median TTD (months) for global health status (self-assessment of overall health and quality of life) in Lutathera arm vs 60 mg octreotide LAR alone was 28.81 vs 6.11 in low; and NR vs 5.98 in moderate/high LTB. Median TTD (months) for physical functioning was 25.20 vs 11.47 in low; and NR vs 11.56 in moderate/high LTB.

Additional sub-analysis evaluated median PFS in patient subgroups with normal or elevated baseline levels of liver enzyme alkaline phosphatase (ALP), and in subgroups with presence or absence of a large (more than 30 mm diameter) lesion at baseline. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with normal ALP was 28.35 vs 8.74. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with elevated ALP was NR vs 5.78. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with a large tumor lesion was 28.35 vs 8.44. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group without a large tumor lesion was NR vs 8.74. Data were presented at the 2018 European Society for Medical Oncology (ESMO) congress.