Tinengotinib exhibits activity in pretreated breast cancer
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SAN ANTONIO — Tinengotinib exhibited activity among heavily pretreated patients with hormone receptor-positive, HER2-negative breast cancer or those with triple-negative disease, according to study results.
Adverse effects among patients who received the agent — either alone or in combination with nab-paclitaxel (Abraxane, Bristol Myers Squibb) — appeared manageable, researchers reported at San Antonio Breast Cancer Symposium.
Background and methods
Tinengotinib (TransThera Bio) is a multikinase inhibitor designed to inhibit Aurora A/Aurora B, FGFR1/FGFR2/FGFR3, VEGF receptors, JAK1/JAK2 and CSF1R.
An SABCS presentation included data from two trials that evaluated tinengotinib for patients with hormone receptor-positive, HER2-ngative breast cancer or triple-negative breast cancer who had no available standard treatment.
Thirty-six patients (median age, 51 years; range, 24-75) with metastatic breast cancer received treatment as of data cutoff in June. The majority (83.3%) had ECOG performance status of 1. Study participants had received a median five prior lines of therapy, and three-quarters (77.8%) received prior taxanes.
Thirty study participants received tinengotinib monotherapy dosed at 5 mg daily (n = 1), 8 mg daily (n = 4), 10 mg daily (n = 5), 12 mg daily (n = 18) or 6 mg every other day (n = 2).
The other six received tinengotinib 8 mg daily in combination with nab-paclitaxel 100 mg/m2.
Safety results
Twenty-six (86.7%) patients who received tinengotinib monotherapy experienced treatment related adverse events (43.4% grade 1/grade 2, 43.3% grade 3, no grade 4/grade 5).
The most common treatment-related adverse events associated with tinengotinib monotherapy included hypertension (60%), stomatitis (50%), palmar-plantar erythrodysesthesia syndrome (46.7%) and diarrhea (20%).
All six patients who received tinengotinib with nab-paclitaxel experienced treatment-related adverse events (16.7% grade 1, 66.7% grade 3, no grade 4, one grade 5 pulmonary hemorrhage).
The most common treatment-related adverse events among patients treated with the combination included neutropenia (50%), stomatitis (50%), hypertension (33.3%), hyponatremia (33.3%), hypokalemia (33.3%) and nausea (33.3%).
Efficacy results
The efficacy analysis included 28 patients who received tinengotinib monotherapy.
Eleven (45.5%) with hormone receptor-positive, HER2-negative disease achieved objective response. Researchers reported a 54.5% clinical benefit rate in this group, with median PFS of 5.5 months (95% CI, 1.97-6.18).
Three of five patients with HER2-zero breast cancer, as well as two of six patients with HER2-low disease, achieved partial responses.
Seventeen patients (23.5%) with triple-negative breast cancer achieved objective response, with researchers reporting a 29.4% clinical benefit rate and median PFS of 2.73 months (95% CI, 1.68-6.41) in this group.
Among six patients who received tinengotinib with nab-paclitaxel, one of two with hormone receptor-positive, HER2-negative disease achieved partial response (duration, 13 weeks as of data cutoff), and two of four patients with triple-negative breast cancer exhibited stable disease.
Researchers observed no significant difference in tinengotinib exposure between the monotherapy and combination groups.
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Piha-Paul SA, et al. Abstract RF01-07. Presented at: San Antonio Breast Cancer Symposium; Dec. 5-9, 2023; San Antonio.
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