A pooled analysis of surufatinib safety from phase 3 trials in advanced NETs.

• DOI: 10.1200/jco.2022.40.16_suppl.4126
• Publication Date: 2022-06-06T16:17:45Z
• Authors: Jie Li; Jianming Xu; Lin Shen; Chunmei Bai; Zhiwei Zhou; Zhiping Li; Yihebali Chi; Xianjun Yu; Enxiao LI; Nong Xu; Tianshu Liu; Wenhui Lou; Yuxian Bai; Xianglin Yuan; Xiuwen Wang; Ying Yuan; Jia Chen; Tao Zhang; Dianrong Xiu; Weiguo Su
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

4126 Background: Surufatinib is a small-molecule inhibitor of VEGFR1, 2, & 3, FGFR1, and CSF-1R. demonstrated prolonged PFS tolerable safety in two phase 3 studies advanced neuroendocrine tumors (NETs) pancreatic (SANET-p; NCT02589821) extrapancreatic (SANET-ep; NCT02588170) origin (Xu, 2020 Lancet Oncology). Detailed outcomes on from these 2 are reported here as pooled analysis. Methods: Data SANET-p SANET-ep which have similar designs including 2:1 randomization surufatinib to placebo patients ≥18 years with advanced, well differentiated NETs, progressing or after ≤2 prior therapies. 300 mg placebo, was administered once daily until disease progression unacceptable toxicity. Safety for each treatment group treatment-emergent adverse events (TEAE) assessed by NCI-CTC 4.03. Patients were included if they had received study during the double-blinded studies. Results: As 30 th June 2020, 396 assigned (n = 263) 133) groups. Median duration longer 7.4 months (range 0.1–41.4) compared 4.6 0.1–39.9). 29% reached more than 12 11% placebo. The mean relative dose intensity 87.56% 97.01% group. Most common TEAEs (surufatinib vs placebo) proteinuria 68.8% 54.9%, hypertension 68.4% 27.1%, diarrhea 49% 22.6%. grade ≥3 TEAE 38.8% 13.5%, 14.8% 0.8% hypertriglyceridaemia 5.3% 0%. Deaths due comparable between groups 2.7% 2.3%. led reductions 43.0% 6.8% interruptions 47.1% 29.3% patients. majority (83.3% 93.2%) managed without discontinuation because TEAE. onset < 1 month both (range) 0.95 (0.16–30.36) (0.23–16.95) 0.49 (0.03–31.18) 0.89 (0.03–14.75) hypertension. Among hypertension, 59% 111) 28% 11) antihypertensive medication. Conclusions: generally tolerated this analysis profile consistent its previously data. monitoring management important receiving surufatinib. Clinical trial information: NCT02589821; NCT02588170. [Table: see text]