Table 3.
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Patients with SD for ≥ 24 weeks or PR by RECIST v1.1.

Patient characteristicsTinengotinibBest response by RECIST version 1.1
Cancer typeFGFR alterationsaPrior systemic therapies, nPrevious targeted therapiesDose, mg/dayDuration of treatment, weeks
1001-25CholangiocarcinomaFGFR2 N549K, FGFR2-KCNH7 fusion3Derazantinib838.3PR
1001-37CholangiocarcinomaFGFR2 C382R3Derazantinib1032.8PR
1001-41bHR+/HER2− breast cancerFGFR2 rearrangement13Palbociclib; SYK/FLT3 inhibitord; PIM kinase inhibitord1212.1PR
2001-50HR+/HER2− breast cancerNone6None1025PR
1001-74bTNBCNone8None1216.1PR
1001-64bProstate adenocarcinomaFGFR2 amplification13SUMO-activating enzyme inhibitord1221.9PR
1001-79bCholangiocarcinomaFGFR2-CCDC6.F17C2c4Pemigatinib1228PR
1001-34CholangiocarcinomaFGFR2-AHCYL1.F17A24Infigratinib1033.9SD
1001-15HR+/HER2− breast cancerNone7NO synthase inhibitord826.1SD
2001-24TNBCNone3None524.6SD
1001-66bRectum adenocarcinomaFGFR1 amplification5Pemigatinib1226SD
1001-67bEpithelioid mesotheliomaNone3Bevacizumab1250.4SD
1001-05Salivary gland adenocarcinomaNone3Ceritinib; abemaciclib536.4SD
Patient characteristicsTinengotinibBest response by RECIST version 1.1
Cancer typeFGFR alterationsaPrior systemic therapies, nPrevious targeted therapiesDose, mg/dayDuration of treatment, weeks
1001-25CholangiocarcinomaFGFR2 N549K, FGFR2-KCNH7 fusion3Derazantinib838.3PR
1001-37CholangiocarcinomaFGFR2 C382R3Derazantinib1032.8PR
1001-41bHR+/HER2− breast cancerFGFR2 rearrangement13Palbociclib; SYK/FLT3 inhibitord; PIM kinase inhibitord1212.1PR
2001-50HR+/HER2− breast cancerNone6None1025PR
1001-74bTNBCNone8None1216.1PR
1001-64bProstate adenocarcinomaFGFR2 amplification13SUMO-activating enzyme inhibitord1221.9PR
1001-79bCholangiocarcinomaFGFR2-CCDC6.F17C2c4Pemigatinib1228PR
1001-34CholangiocarcinomaFGFR2-AHCYL1.F17A24Infigratinib1033.9SD
1001-15HR+/HER2− breast cancerNone7NO synthase inhibitord826.1SD
2001-24TNBCNone3None524.6SD
1001-66bRectum adenocarcinomaFGFR1 amplification5Pemigatinib1226SD
1001-67bEpithelioid mesotheliomaNone3Bevacizumab1250.4SD
1001-05Salivary gland adenocarcinomaNone3Ceritinib; abemaciclib536.4SD

Abbreviations: DRDE, dose recommended for dose expansion; FGFR, fibroblast growth factor receptor; FLT3, FMS-like tyrosine kinase 3; HER2−, human epidermal growth factor 2-negative; HR+, hormone receptor-positive; NO, nitric oxide; PIM, proviral integration site of Moloney murine leukemia virus; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SUMO, small ubiquitin-like modifier; SYK, spleen tyrosine kinase; TNBC, triple-negative breast cancer.

aIndicates historical FGFR mutational status obtained from medical records review.

bIndicates patient treated at DRDE.

cIndicates FGFR mutational status obtained from next-generation sequencing performed during study screening and prior to study entry.

dInvestigational agent under study.

Table 3.
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Patients with SD for ≥ 24 weeks or PR by RECIST v1.1.

Patient characteristicsTinengotinibBest response by RECIST version 1.1
Cancer typeFGFR alterationsaPrior systemic therapies, nPrevious targeted therapiesDose, mg/dayDuration of treatment, weeks
1001-25CholangiocarcinomaFGFR2 N549K, FGFR2-KCNH7 fusion3Derazantinib838.3PR
1001-37CholangiocarcinomaFGFR2 C382R3Derazantinib1032.8PR
1001-41bHR+/HER2− breast cancerFGFR2 rearrangement13Palbociclib; SYK/FLT3 inhibitord; PIM kinase inhibitord1212.1PR
2001-50HR+/HER2− breast cancerNone6None1025PR
1001-74bTNBCNone8None1216.1PR
1001-64bProstate adenocarcinomaFGFR2 amplification13SUMO-activating enzyme inhibitord1221.9PR
1001-79bCholangiocarcinomaFGFR2-CCDC6.F17C2c4Pemigatinib1228PR
1001-34CholangiocarcinomaFGFR2-AHCYL1.F17A24Infigratinib1033.9SD
1001-15HR+/HER2− breast cancerNone7NO synthase inhibitord826.1SD
2001-24TNBCNone3None524.6SD
1001-66bRectum adenocarcinomaFGFR1 amplification5Pemigatinib1226SD
1001-67bEpithelioid mesotheliomaNone3Bevacizumab1250.4SD
1001-05Salivary gland adenocarcinomaNone3Ceritinib; abemaciclib536.4SD
Patient characteristicsTinengotinibBest response by RECIST version 1.1
Cancer typeFGFR alterationsaPrior systemic therapies, nPrevious targeted therapiesDose, mg/dayDuration of treatment, weeks
1001-25CholangiocarcinomaFGFR2 N549K, FGFR2-KCNH7 fusion3Derazantinib838.3PR
1001-37CholangiocarcinomaFGFR2 C382R3Derazantinib1032.8PR
1001-41bHR+/HER2− breast cancerFGFR2 rearrangement13Palbociclib; SYK/FLT3 inhibitord; PIM kinase inhibitord1212.1PR
2001-50HR+/HER2− breast cancerNone6None1025PR
1001-74bTNBCNone8None1216.1PR
1001-64bProstate adenocarcinomaFGFR2 amplification13SUMO-activating enzyme inhibitord1221.9PR
1001-79bCholangiocarcinomaFGFR2-CCDC6.F17C2c4Pemigatinib1228PR
1001-34CholangiocarcinomaFGFR2-AHCYL1.F17A24Infigratinib1033.9SD
1001-15HR+/HER2− breast cancerNone7NO synthase inhibitord826.1SD
2001-24TNBCNone3None524.6SD
1001-66bRectum adenocarcinomaFGFR1 amplification5Pemigatinib1226SD
1001-67bEpithelioid mesotheliomaNone3Bevacizumab1250.4SD
1001-05Salivary gland adenocarcinomaNone3Ceritinib; abemaciclib536.4SD

Abbreviations: DRDE, dose recommended for dose expansion; FGFR, fibroblast growth factor receptor; FLT3, FMS-like tyrosine kinase 3; HER2−, human epidermal growth factor 2-negative; HR+, hormone receptor-positive; NO, nitric oxide; PIM, proviral integration site of Moloney murine leukemia virus; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SUMO, small ubiquitin-like modifier; SYK, spleen tyrosine kinase; TNBC, triple-negative breast cancer.

aIndicates historical FGFR mutational status obtained from medical records review.

bIndicates patient treated at DRDE.

cIndicates FGFR mutational status obtained from next-generation sequencing performed during study screening and prior to study entry.

dInvestigational agent under study.

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