Sunitinib in Patients With Various Solid Tumors With FGFR1 / 2 Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.
Gordan Srkalovic, Michael Rothe, Elizabeth Garrett-Mayer et al.
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In 30 seconds
This phase II basket trial evaluated sunitinib in patients with advanced solid tumours and FGFR1 or FGFR2 alterations who had no remaining standard treatment options. Histology-specific cohorts were pooled by alteration. Disease control—objective response or stable disease lasting at least 16 weeks—was 21% in the FGFR1 cohort and 39% in the FGFR2 cohort. The prespecified activity threshold was met for FGFR2 but not FGFR1, indicating a signal of activity for sunitinib in the FGFR2-altered cohort, but not establishing benefit across tumour types.
Key findings
- Disease control was 21% in the FGFR1 cohort; the prespecified null hypothesis was not rejected (P = .24).
- Disease control was 39% in the FGFR2 cohort, meeting the prespecified activity criterion (P = .0015).
- Twenty patients experienced at least one treatment-related grade 3-5 adverse event or serious adverse event.
Why it matters
The findings suggest that FGFR alteration subtype may be relevant when assessing sunitinib activity across diverse solid tumours. The FGFR2 result provides a clinical signal in a population with limited standard options, while the lack of a signal for FGFR1 cautions against treating these alterations as interchangeable. The study does not establish efficacy for individual tumour types.
What to keep in mind
The analysis pooled histology-specific cohorts across 20 cancer types, limiting conclusions for any individual tumour type. Eight patients in the FGFR1 cohort were not evaluable for efficacy.