Multikinase Inhibition with Tinengotinib in Advanced Solid Tumors: Results from a Multicenter Phase Ib/II Trial.
Sarina A Piha-Paul, Chih-Yi Liao, Farshid Dayyani et al.
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In 30 seconds
This multicenter phase Ib/II trial evaluated tinengotinib’s safety, pharmacokinetics, antitumor activity, and genomic correlates in patients with advanced or metastatic solid tumors lacking standard treatment options. Among 197 treated patients, treatment-related treatment-emergent adverse events occurred in 160 (81.2%), most commonly hypertension. Of 159 evaluable patients, 43 (27.0%) achieved clinical benefit, defined as complete or partial response or stable disease lasting at least 6 months. Activity was most pronounced at 10-mg and 12-mg dose levels; pharmacokinetic analyses supported 10 mg once daily.
Key findings
- Clinical benefit occurred in 43 of 159 (27.0%) evaluable patients: 1 complete response, 20 partial responses, and 22 stable diseases ≥6 months.
- Objective response rates were 33.3% in prostate cancer (n = 15), 30% in breast cancer (n = 20), and 13% in cholangiocarcinoma (n = 23).
- Treatment-related treatment-emergent adverse events occurred in 160 of 197 patients (81.2%); hypertension was most common, while hyperphosphatemia and ocular toxicities were uncommon.
- Pharmacokinetic analyses supported the 10-mg once-daily regimen; exploratory analyses identified FGFR2 fusions in cholangiocarcinoma responders.
Why it matters
The findings provide early clinical evidence that tinengotinib has antitumor activity across several advanced solid-tumor types, alongside a safety profile the investigators characterized as manageable. The response differences across tumor types and exploratory genomic associations may help guide further study, but they do not establish which patients will benefit or confirm biomarker-based treatment selection.
What to keep in mind
This was an early-phase study in a heterogeneous population, with multiple dose levels and schedules. Genomic correlations were exploratory, and the abstract does not report comparative efficacy against another treatment.