Final survival results for the LURET phase II study of vandetanib in previously treated patients with RET-rearranged advanced non-small cell lung cancer
Mené sur 19 patients atteints d'un cancer du poumon non à petites cellules de stade avancé et présentant des réarrangements du gène RET, cet essai de phase II évalue l'efficacité, du point de vue de la survie sans progression, et la toxicité du vandétanib après l'échec de plusieurs lignes thérapeutiques (nombre de traitements antérieurs : 3 ou plus)
Objectives : The LURET phase II study evaluated the efficacy and safety of the multikinase inhibitorvandetanib in patients with previously treated RET-rearranged advanced non-small cell lung cancer (NSCLC). Among the eligible patientsincluded in the primary analysis, the objective response rate met the primary endpoint(53%, 90% confidence interval [CI]: 31-74). Here, we report final survival outcomesof the LURET study. Materials and methods : Nineteen patients with previously treated RET-rearranged advanced NSCLC continuously received 300 mg of oral vandetanib daily.This final analysis provides updated data on progression-free survival (PFS), overallsurvival (OS) and safety. This study was registered with UMIN-CTR (number UMIN 000010095). Results : Among the 19 patients in the intention-to-treat population, 42% had been heavily treatedwith 3 or more prior chemotherapy regimens. The median PFS was 6.5 months (95% CI,3.9-9.3) as determined by an independent radiology review committee. The median OSwas 13.5 months (95% CI, 9.8-28.1) and the overall survival rate at 12 months was52.6% (95% CI 28.7-71.9). The most common adverse events were hypertension (84.2%),diarrhea (78.9%), and rash acneiform (63.2%). Overall, 11 patients (57.9%) had adverseevents leading to a dose reduction, although the safety profile was consistent withthat reported in previous studies. Conclusion : Our results indicated that vandetanib enabled a prolonged and clinically meaningfulPFS and OS in patients with previously treated RET-rearranged advanced NSCLC at the updated final analysis. The safety profile was consistentwith that reported in previous studies, although most of the patients experiencedoff-target adverse events besides RET.
Lung Cancer 2021