NANETS2025 18th Annual Multidisciplinary NET Medical Symposium NANETS 2025 Clinical – Nuclear Medicine/Interventional Radiology/Imaging (22 abstracts)
Efficacy of 177Lu-edotreotide vs everolimus in patients with grade 1 or grade 2 GEP-NETs: Phase 3 COMPETE trial (post hoc subgroup analyses)
Jaume Capdevila 1 , Henning Jann 2 , Catherine Ansquer 3 , Emmanuel Deshayes 4 , Rocio Garcia-Carbonero 5 , Alexandre Teulé Vega 6 , Richard Paul Baum 7 , Hein Jan Verberne 8 , Cwikla Jaroslaw Bogdan 9 , Rajaventhan Srirajaskanthan 10 , Louis De Mestier 11 , Chiara Maria Grana 12 , Andreas Buck 13 , Dieter Hörsch 14 , Marianne Pavel 15 , Dierickx Lawrence Oliver 16 , Michael Michael 17 , Jonathan Strosberg 18 , Attila Kollàr 19 , Paula Jimenez-Fonseca 20 , Andreas Kluge 21 , Veronika Smutna 22 , Richardus Vonk 22 , Konstantin Zhernosekov 23 & Thomas Walter 24
1Vall d’Hebron Hospital Universitari and Neuroendocrine and Endocrine Tumor Translational Research Program (NET-VHIO), Vall d’Hebron Institute of Oncology (VHIO); 2Charité – Universitätsmedizin Berlin; 3Centre Hospitalier Universitaire de Nantes; 4Institut du Cancer de Montpellier Val d’Aurelle and Montpellier University; 5Hospital Universitario 12 de Octubre, Imas12, UCM; 6Institut Català d’Oncologia; 7Curanosticum Wiesbaden-Frankfurt; 8Amsterdam UMC; 9Diagnostic and Therapeutic Center – Gammed and School of Medicine University of Warmia and Mazury Olsztyn; 10King’s College Hospital; 11Beaujon Hospital; 12IRCCS European Institute of Oncology; 13Universitätsklinikum Würzburg; 14Zentralklinik Bad Berka GmbH; 15Universitätsklinikum Erlangen; 16Institut Universitaire du Cancer Toulouse Oncopole; 17Peter MacCallum Cancer Centre and University of Melbourne; 18Moffitt Cancer Center; 19Bern University Hospital; 20Universitario Central de Asturias; 21ABX-CRO advanced pharmaceutical services Forschungsgesellschaft mbH; 22ITM Oncologics GmbH; 23ITM Medical Isotopes GmbH; 24Edouard Herriot Hospital
Background: 177Lu-edotreotide is an innovative radiopharmaceutical therapy agent, assessed in COMPETE, a Phase III, multicenter, randomized, controlled and open-label trial comparing 177Lu-edotreotide with a targeted molecular therapy (everolimus) in patients with WHO grade 1 or grade 2 gastroenteropancreatic-neuroendocrine tumors (GEP-NETs). Here, we focus on post hoc efficacy analyses of 177Lu-edotreotide in clinically important subgroups.
Methods: Eligible patients (aged ≥18 years) with inoperable, progressive, somatostatin receptor positive GEP-NETs (Ki-67 ≤20%) were randomized (2:1) to receive 177Lu-edotreotide (4 cycles of 7.5 GBq/cycle every 12 weeks, or until disease progression) or everolimus (10 mg daily up to 30 months, or until disease progression). The primary endpoint was progression free survival (PFS) per RECIST v1.1 assessed by Blinded Independent Central Review (BICR). Key secondary endpoints were objective response rate (ORR) and overall survival (OS).
Results: 309 patients were randomized to 177Lu-edotreotide (n = 207) or everolimus (n = 102). Median PFS was significantly prolonged by 177Lu-edotreotide vs. everolimus (23.9 months vs. 14.1 months; P = 0.0223; HR=0.673, 95% CI [0.477, 0.948]). Centrally assessed ORR was significantly higher with 177Lu-edotreotide vs. everolimus (21.9% vs. 4.2%; P < 0.0001). Preliminary median OS was numerically prolonged for 177Lu-edotreotide vs. everolimus (63.4 months vs. 58.7 months; P = 0.3230; HR=0.826, 95% CI [0.565, 1.208]). The subgroup analyses showed consistent improvements in PFS, ORR, and OS across subgroups, except for OS (immature data) reported in the treatment-naïve subgroup (Table).
| Subgroups | Median PFS177Lu-edotreotide vs. everolimus (months) | ORR177Lu-edotreotide vs. everolimus (%) | Median OS177Lu-edotreotide vs. everolimus (months) |
| Grade 1 | 24.5 (n = 104) vs. 17.4 (n = 63) | 15.8 (n = 101) vs. 3.3 (n = 61) | NR (n = 104) vs. NR (n = 63) |
| Grade 2 | 21.6 (n = 102) vs. 10.6 (n = 37) | 28.3 (n = 99) vs. 3.1 (n = 32) | 56.7 (n = 102) vs. 41.4 (n = 37) |
| GE-NET | 23.9 (n = 88) vs. 12.0 (n = 43) | 6.0 (n = 84) vs. 5.0 (n = 40) | 63.4 (n = 88) vs. 58.7 (n = 43) |
| P-NET | 24.5 (n = 119) vs. 14.7 (n = 59) | 33.3 (n = 117) vs. 3.6 (n = 55) | 65.7 (n = 119) vs. 49.3 (n = 59) |
| Treatment-naïve (1st line) | NR (n = 30) vs. 18.1 (n = 17) | 17.9 (n = 28) vs. 5.9 (n = 17) | 57.4 (n = 30) vs. NR (n = 17) |
| Prior therapy (2nd line) | 23.9 (n = 177) vs. 14.1 (n = 85) | 22.5 (n = 173) vs. 3.8 (n = 78) | 63.4 (n = 177) vs. 43.3 (n = 85) |
| n=total number of patients; NR=not reached | |||
Conclusions: 177Lu-edotreotide demonstrated statistically significant improvements in PFS and ORR vs. everolimus. Despite the immature data, potential OS benefit was observed with 177Lu-edotreotide vs. everolimus. The efficacy of 177Lu-edotreotide was largely maintained across the subgroups (origin, grade, and prior treatment). These findings confirm the meaningful clinical benefit of 177Lu-edotreotide vs. everolimus in GEP-NETs patients with high unmet needs.
Abstract ID #33388
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Endocrine Abstracts
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