The NETTER-2 trial demonstrated that lutetium-177 (¹⁷⁷Lu)-dotatate is highly effective as a first-line treatment for patients with newly diagnosed, advanced, well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) of grades 2 and 3. The study found a significant improvement in progression-free survival (PFS) and objective response rates (ORR) compared to the standard treatment of high-dose octreotide LAR.
Key Findings of the NETTER-2 Trial
- Progression-Free Survival (PFS): Patients treated with ¹⁷⁷Lu-dotatate had a median PFS of 22.8 months, which was a substantial increase compared to 8.5 months in the group treated with high-dose octreotide LAR alone.
- Objective Response Rate (ORR): The ORR was significantly higher in the ¹⁷⁷Lu-dotatate group (43.0%) versus the control group (9.3%). This means that a much larger percentage of patients on ¹⁷⁷Lu-dotatate experienced a measurable tumor shrinkage.
- Safety and Tolerability: The safety profile of ¹⁷⁷Lu-dotatate in this trial was consistent with its known profile from previous studies, with manageable and transient hematologic adverse events being the most common. There were no new safety concerns identified.
- Subgroup Analysis: The efficacy of ¹⁷⁷Lu-dotatate was consistent across different subgroups, including those with Grade 2 and Grade 3 tumors and those with tumors originating in the pancreas versus other locations.
Based on these results, the NETTER-2 trial suggests that ¹⁷⁷Lu-dotatate should be considered a new standard of care as a first-line treatment for this specific patient population