. 2024 Jul 22;31(9):e230337. doi: 10.1530/ERC-23-0337
This work is licensed under a Table 2.
Secondary efficacy endpoints: objective response ratea and clinical benefit rateb (centrally assessed; ITT population).
| Double-blind phase | |||||||
|---|---|---|---|---|---|---|---|
| n (%) (95% CI) | LAN vs PBO treatment difference (95% CI) | ||||||
| LAN (n = 51) | PBO (n= 26) | ||||||
| ORRa | 7/50 (14.0) (5.82; 26.74) | 0/25 (0) (0.00; 13.72) | 14.0 (−10.97; 37.86) | ||||
| CBRb | 45/50 (90.0) (78.19; 96.67) | 23/25 (92.0) (73.97; 99.02) | −2.00 (−26.53; 22.69) | ||||
| Open-label treatment phase | |||||||
| n (%) (95% CI) | Treatment difference (95% CI) | ||||||
| LAN (NPD)–LAN (n = 21) | PBO (NPD)–LAN (n = 9) | PBO (PD)–LAN (n= 10) | All patients (n = 40) | LAN (NPD)–LAN vs PBO (NPD)–LAN | LAN (NPD)–LAN vs PBO (PD)–LAN | ||
| CBRb | 21/21 (100) (83.89; 100) | 8/8 (100) (63.06; 100) | 7/9 (77.8) (39.99; 97.19) | 36/38 (94.7) (82.25; 99.36) | 0 (NC; NC) | 22.2 (−17.64; 60.01) | |
Note that ORR during the open-label treatment phase is not provided because it was not a pre-specified endpoint. Tumors were assessed according to RECIST v1.1 criteria.
aComplete responses plus partial responses; bComplete responses plus partial responses plus stable disease.
CBR, clinical benefit rate; ITT, intention-to-treat; LAN, lanreotide autogel/depot; NC, not calculable; NPD, no progressive disease; ORR, objective response rate; PBO, placebo; PD, progressive disease; RECIST, Response Evaluation Criteria in Solid Tumors.