Abstract 1039P
Background
Surufatinib is a novel small-molecule kinase inhibitor targeting VEGFRs, FGFR and CSF-1R. In two phase 3 randomized trials (NCT02588170 & NCT02589821) surufatinib demonstrated a manageable safety profile and statistically significant efficacy and was recently approved for the treatment of patients (pts) with epNET and pNET in China. Here, we performed this trial to investigate the efficacy and safety of surufatinib in patients with advanced NSCLC progressing after second-line or further treatment.
Methods
This single center, single-arm, two-cohorts, open-label, phase Ⅱ study (NCT04922658) has two parallel cohorts, cohort 1 received surufatinib (250 mg QD on day 1-21, Q3W) plus vinorelbine (60 mg / m2 BSA, on d1, d8, d15，Q3W); cohort 2 received surufatinib (300mg QD on day 1-21, Q3W). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Here we report the primary results of cohort 2.
Results
From July 2021 to April 2022, 14 pts were enrolled in cohort 2 (Table), and 10 had received at least one tumor assessment. All 10 pts achieved SD, and DCR was 100%. Median PFS was not reached yet. By April 22, 2022 data cutoff, the longest PFS was 8.3 months, and 8 pts are still receiving treatment. The most common treatment-emergent adverse events (TEAEs) (Total; Grade ≥3) were hypoalbuminaemia (50%; 21.4%), proteinuria (50.0%; 28.6%), blood thyroid-stimulating hormone increased (42.9%; 0%), hypertension (35.7%; 21.4%). No pts had serious adverse events. Table: 1039P
| Surufatinib (n=14) | |
| Age (years old), n(%) | |
| ＞65 | 11 (79%) |
| ≤65 | 3 (21%) |
| Sex, n (%) | |
| Male | 8 (57%) |
| Female | 6 (43%) |
| ECOG PS, n (%) | |
| 0 | 0 |
| 1 | 14 (100%) |
| 2 | 0 |
| No. of therapy lines | |
| 3 lines | 7 (50%) |
| ＞3 lines | 7 (50%) |
| Histology | |
| Adenocarcinoma | 8 (57%) |
| Squamous | 4 (43%) |
| Clinical stage | |
| Ⅲ | 2 (14%) |
| Ⅳ | 12 (86%) |
Conclusions
This finding showed promising efficacy for surufatinib in pts with advanced NSCLC as third-line or further treatment, with a manageable safety profile. The PFS and OS outcomes need further evaluation. These findings support surufatinib as a potential new third-line or further treatment option for advanced NSCLC.
Clinical trial identification
NCT04922658; June 10, 2021.
Editorial acknowledgement
Legal entity responsible for the study
Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.