The LURET phase II trial evaluated the efficacy and safety of vandetanib in patients with advanced RET-rearranged non-small cell lung cancer (NSCLC). Among eligible patients included in primary analysis, objective response rate (ORR) met the primary endpoint (53% [90% CI 31-74]). Here, we report a final analysis of survival outcomes in LURET.
In all, 19 patients with advanced RET-rearranged NSCLC continuously received 300 mg of oral vandetanib daily. The variant types of RET fusion included 10 KIF5B-RET, 6 CCDC6-RET, and 3 unknown. The data cutoff date was Aug 31, 2017, for a final analysis. In this final analysis, the data on progression-free survival (PFS), overall survival (OS) and safety were updated.
At the final data cutoff, 1 patient was still receiving vandetanib without disease progression. Among all 19 patients in the intention-to-treat population, median PFS was 6.5 months (95% CI, 2.8-8.5) as determined by the independent radiology review committee. Median OS was 13.5 months (95% CI, 9.8-28.1) and the overall survival rate at 12 months was 52.6% (95% CI 28.7-71.9). In the subgroup analysis according to the type of RET fusion, median PFS and OS were 2.9 months (95% CI 1.1-15.7) and 10.5 months (95% CI 3.0-18.1) in patients with KIF5B-RET whereas 8.4 (95% CI 4.7-not reached [NR]) and NR (95% CI 9.9-NR) in those with CCDC6-RET. No new adverse events were observed compared with previous studies in unselected NSCLC.
Our results found that vandetanib to be effective in patients with advanced RET-rearranged NSCLC, and that RET rearrangement may be a favorable molecular subgroup of NSCLC suitable for targeted therapy.
Clinical trial identification
This study is registered with UMIN-CTR, number UMIN000010095.
Legal entity responsible for the study
National Cancer Center Hospital East.
Sanofi, AstraZeneca, the Ministry of Health, Labour, and Welfare of Japan and the Practical Research for Innovation Cancer Control from the Japan Agency for Medical Research and Development, AMED.
K. Yoh, T. Seto, M. Satouchi: Research funding and honoraria: AstraZeneca. M. Nishio, H. Murakami: Speakers’ bureau, Research funding and honoraria: AstraZeneca. N. Nogami: Research honoraria: AstraZeneca. A. Sato: Speakers’ bureau: AstraZeneca. K. Goto: Research funding: AstraZeneca. All other authors have declared no conflicts of interest.