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. 2024 Jan 31;29(4):e514–e525. doi: 10.1093/oncolo/oyad338

Table 3.

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

Patient characteristics Tinengotinib Best response by RECIST version 1.1
Cancer type FGFR alterationsa Prior systemic therapies, n Previous targeted therapies Dose, mg/day Duration of treatment, weeks
1001-25 Cholangiocarcinoma FGFR2 N549K, FGFR2-KCNH7 fusion 3 Derazantinib 8 38.3 PR
1001-37 Cholangiocarcinoma FGFR2 C382R 3 Derazantinib 10 32.8 PR
1001-41b HR+/HER2− breast cancer FGFR2 rearrangement 13 Palbociclib; SYK/FLT3 inhibitord; PIM kinase inhibitord 12 12.1 PR
2001-50 HR+/HER2− breast cancer None 6 None 10 25 PR
1001-74b TNBC None 8 None 12 16.1 PR
1001-64b Prostate adenocarcinoma FGFR2 amplification 13 SUMO-activating enzyme inhibitord 12 21.9 PR
1001-79b Cholangiocarcinoma FGFR2-CCDC6.F17C2c 4 Pemigatinib 12 28 PR
1001-34 Cholangiocarcinoma FGFR2-AHCYL1.F17A2 4 Infigratinib 10 33.9 SD
1001-15 HR+/HER2− breast cancer None 7 NO synthase inhibitord 8 26.1 SD
2001-24 TNBC None 3 None 5 24.6 SD
1001-66b Rectum adenocarcinoma FGFR1 amplification 5 Pemigatinib 12 26 SD
1001-67b Epithelioid mesothelioma None 3 Bevacizumab 12 50.4 SD
1001-05 Salivary gland adenocarcinoma None 3 Ceritinib; abemaciclib 5 36.4 SD

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.