Katie Hennessy

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, Nashat Gabrail et autres

PURPOSE: Tinengotinib, a multikinase inhibitor targeting Aurora kinases A/B, fibroblast growth factor receptors (FGFRs) 1-3, vascular endothelial growth factor receptor-2, and Janus kinases 1-2, was evaluated in this phase Ib/II study to assess safety, pharmacokinetics, efficacy, and genomic correlates of response and …

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Phase II study of tinengotinib in advanced cholangiocarcinoma: Analysis of molecular response and resistance mechanisms.

Angela Lamarca, Milind M. Javle, C. Fountzilas, Chih-Yi Liao et autres

566 Background: FGFR inhibitors (FGFRi) have an established role in treating FGFR2-altered (alt) cholangiocarcinoma (CCA). Tinengotinib, a novel FGFRi, has shown promising activity overcoming acquired resistance to prior FGFRi. We present biomarker analyses evaluating tinengotinib’s ability to overcome prior FGFRi resistance and …

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Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial

Milind Javle, Christos Fountzilas, Chih‐Yi Liao, Meredith S. Pelster et autres

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Use of an in-silico clinical trial intelligence solution to predict outcomes of tinengotinib, a potent multi-kinase small molecule FGFR inhibitor in patients with cholangiocarcinoma, based on the molecular matching score.

Ally Perlina, Milind Javle, Subha Krishnan, Katie Hennessy et autres

e15190 Background: Cancer genomic diversity, with a median of ~5 pathogenic molecular alterations per tumor, presents a challenge in predicting clinical outcomes of investigational therapies. Precision medicine implies the ability of a drug/drug combination to address the unique molecular profile of an …

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Abstract 4352: Safety and pharmacokinetics of tinengotinib monotherapy in different doses and dosing schedules in advanced solid tumors

Sarina A. Piha‐Paul, Sanjay Goel, Chih‐Yi Liao, Nashat Gabrail et autres

Abstract Background: Tinengotinib is a novel multi-kinase inhibitor that targets cell proliferation, angiogenesis, and immune-oncology pathways by inhibiting Aurora kinases A/B, Janus kinases (JAK) and receptor tyrosine kinases (FGFRs and VEGFRs). Here we present the safety and pharmacokinetics (PK) of tinengotinib monotherapy …

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Abstract 825: Correlation of clinical and biomarker data in FGFR inhibitor failed metastatic cholangiocarcinoma patients with tumor response to tinengotinib

Sarina A. Piha‐Paul, Sanjay Goel, Chih‐Yi Liao, Nashat Gabrail et autres

Abstract Background: Cholangiocarcinoma (CCA) patients (pts) harboring FGFR fusions treated with FGFR inhibitors (FGFRi) have shown clinical benefit, but often have progression in 5- 7 months. Secondary polyclonal mutations in the FGFR2 kinase domain (KD) may be a mechanism for acquired resistance …

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A phase 1b/2 study evaluating the activity of tinengotinib in combination with androgen receptor pathway inhibitors (ARPIs) in patients with metastatic castration resistant prostate cancer (mCRPC).

Wassim Abida, Yu Chen, Deaglan Joseph McHugh, Michael J. Morris et autres

TPS290 Background: Androgen receptor pathway inhibitors (ARPIs) are standard life-prolonging therapies for patients with metastatic castration-resistant prostate cancer (mCRPC), but patients ultimately progress on these agents. Resistance has been shown to occur in part via lineage plasticity mediated by increased activity of …

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Tinengotinib in patients with advanced, metastatic cholangiocarcinoma: Overall survival results and biomarker correlative analysis from a phase 2 clinical trial.

Christos Fountzilas, Chih‐Yi Liao, Meredith S. Pelster, Daneng Li et autres

608 Background: Tinengotinib, a spectrum-selective multi-kinase inhibitor with unique binding properties to FGFR , potently inhibited FGFR2 fusion/rearrangement and acquired resistant/gatekeeper mutations in pre-clinical models and exhibited antitumor activity in cholangiocarcinoma (CCA) patients (pts) in phase 1/2 trials. Here we present the …

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Tinengotinib for Adult Patients with Advanced or Metastatic Cholangiocarcinoma: A Multicenter, Open-Label Phase 2 Trial

Milind Javle, Christos Fountzilas, Chih‐Yi Liao, Meredith S. Pelster et autres

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Abstract RF01-07: The efficacy and safety of tinengotinib in patients with advanced or metastatic HR+/HER2- breast cancer or TNBC

Piha‐Paul Sarina, Binghe Xu, Ying Fan, Yuan Yuan et autres

Abstract Background: Tinengotinib is a novel multiple kinase inhibitor that strongly inhibits Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, and CSF1R. Here we present the preliminary safety, pharmacokinetic and efficacy data of tinengotinib in patients (pts) with hormone receptor positive (HR+)/human epidermal growth factor …

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The efficacy and safety of tinengotinib in patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC).

Guo Hongqian, Sumit K. Subudhi, Weiqing Han, Chih‐Yi Liao et autres

133 Background: Tinengotinib is a spectrum-selective multi-kinase inhibitor that targets cell proliferation, angiogenesis, and immune-oncology pathways by inhibiting Aurora kinases A/B, Janus kinases (JAK), and receptor tyrosine kinases (FGFRs, VEGFRs). It has been reported that the activation of JAK/STAT and fibroblast growth …

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First-308: Phase III study of tinengotinib versus physician's choice in patients with FGFR-altered, chemotherapy- and FGFR inhibitor–refractory/relapsed cholangiocarcinoma.

Milind Javle, Lorenza Rimassa, Lipika Goyal, Amit Mahipal et autres

TPS575 Background: Fibroblast growth factor (FGFR) alterations occur in 10-15% of adult patients with advanced intrahepatic cholangiocarcinoma (CCA) and 1-2% of adult patients with advanced extrahepatic cholangiocarcinoma. The first generation FGFR inhibitors (FGFRi) pemigatinib and futibatinib, have been approved for the treatment …

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