Efficacy
Efficacy Across Clinical Trials
Statistically significant improvement in PFS demonstrated across a range of patients with SSTR+ GEP-NETs1-4:
LUTATHERA in NETTER-1 and NETTER-2
Sandy Kotiah, MD, provides her insights into the efficacy and safety of LUTATHERA in the clinical trials.
![Grade 2/3 SSTR+ GEP-NETs 72% REDUCTION in the risk of disease progression or death with LUTATHERA + 30 mg octreotide LAR (median PFS, 22.8 months [95% CI,19.4-NE]) vs 60 mg octreotide LAR (median PFS, 8.5 months [95% CI, 7.7-13.8]) (HR, 0.28 [95% CI, 0.18-0.42]; P<.0001)](https://usim.beprod.lutathera-hcp.com/sites/lutathera_hcp_com/files/styles/webp/public/styles/common_width_472/public/2024-09/lutathera_hcp_website_callout_72_percent_mobile_0.png.webp?itok=iOY6po_k)
 | Newly diagnosed (within last 6 months), well-differentiated SSTR+ GEP-NET |
| Karnofsky PS: 90 to 100 |
| Ki-67 index: ≥10% to ≤55% (tumor grade 2/3) |
| Disease burden: moderate to extensive |
![Grade 1/2 SSTR+ GEP-NETs 79% REDUCTION in the risk of disease progression or death with LUTATHERA + 30 mg octreotide LAR (median PFS, not reached [95% CI,18.4-NE]) vs 60 mg octreotide LAR (median PFS, 8.5 months [95% CI, 6.0-9.1]) (HR, 0.21 [95% CI, 0.13-0.32]; P<.0001)](https://usim.beprod.lutathera-hcp.com/sites/lutathera_hcp_com/files/styles/webp/public/styles/common_width_472/public/2024-09/lutathera_hcp_website_callout_79_percent_mobile.png.webp?itok=K8npNYbe)
 | Well-differentiated SSTR+ GEP-NET and progression on SSA |
| Karnofsky PS: 75 to 95 |
| Ki-67 index: <10% (tumor grade 1/2) |
This is a representation of the typical patient in the NETTER-1 and NETTER-2 trials. This list is NOT intended to be exhaustive of all inclusion/exclusion criteria.
LUTATHERA (lutetium Lu 177 dotatate) has a well-established safety profile across NETTER-1 and NETTER-21-4
NETTER-2 is a phase 3, randomized, open-label, active comparator, multicenter study of the efficacy of LUTATHERA with 30 mg octreotide LAR (n=151) vs 60 mg octreotide LAR (n=75) in patients with newly diagnosed, well-differentiated, grade 2/3 advanced SSTR+ GEP-NETs. SSA-naive patients were eligible, as well as patients previously treated with SSAs in the absence of progression. The primary end point of the study was centrally assessed PFS. The median PFS in the LUTATHERA arm was 22.8 months (95% CI, 19.4-NE) vs 8.5 months (95% CI, 7.7-13.8) in the control arm.1,4,*
NETTER-1 was a pivotal, phase 3, randomized, multicenter, open-label study of LUTATHERA with 30 mg octreotide LAR (n=116) vs 60 mg octreotide LAR (n=113) in patients with locally advanced, inoperable, or metastatic grade 1/2 SSTR+ GEP-NETs after progression on an SSA. The primary end point of the study was centrally assessed PFS. The median PFS in the LUTATHERA arm was not reached at primary analysis (95% CI, 18.4-NE) vs 8.5 months (95% CI, 6.0-9.1) in the control arm.2,3,7,*
GEP-NETs, gastroenteropancreatic neuroendocrine tumors; HR, hazard ratio; LAR, long-acting release; NE, not evaluable; PFS, progression-free survival; PS, performance score; RECIST, Response Evaluation Criteria in Solid Tumors; SSA, somatostatin analogue; SSTR+, somatostatin receptor-positive.