التفاصيل البيبلوغرافية
| العنوان: |
P1-156 Preliminary results from fight-102: a phase 1 study of pemigatinib in Japanese patients with advanced malignancies. |
| المؤلفون: |
Kuboki, Yasutoshi1 (AUTHOR), Furukawa, Masayuki2 (AUTHOR), Takahashi, Yasuo3 (AUTHOR), Mizuno, Nobumasa4 (AUTHOR), Hara, Hiroki5 (AUTHOR), Ueno, Makoto6 (AUTHOR), Ioka, Tatsuya7 (AUTHOR), Takahashi, Shunji8 (AUTHOR), Shimizu, Toshio9 (AUTHOR), Lihou, Christine F10 (AUTHOR), Tian, Chenwei10 (AUTHOR), Ji, Tao10 (AUTHOR), Fujiwara, Yutaka9 (AUTHOR) |
| المصدر: |
Annals of Oncology. 2019 Supplement, Vol. 30, pN.PAG-N.PAG. 1p. |
| مصطلحات موضوعية: |
*FIBROBLAST growth factors, *FIBROBLAST growth factor receptors, *CHOLANGITIS |
| مستخلص: |
Background Dysregulated fibroblast growth factor (FGF)/FGF receptor (FGFR) signaling resulting from oncogenic FGFR alterations is implicated in many cancers. Pemigatinib (INCB054828) is an oral, selective FGFR1, 2, and 3 inhibitor. This phase 1, multisite, open-label study evaluated pemigatinib in Japanese patients (pts) with advanced malignancies (NCT03235570). Methods Japanese pts (≥20 y) in part 1 (dose escalation) had advanced solid tumors and no standard therapies available. Pts in part 2 (dose expansion) had measurable disease with FGF/FGFR alterations. Part 1 pts were enrolled using a 3 + 3 design to receive pemigatinib starting at 9 mg QD and then at 13.5 mg QD, each on 21-d 2-wk on/1-wk off intermittent dosing cycles. Part 2 pts started at the recommended phase 2 dose (RP2D). Primary endpoint was safety. Results As of the data cutoff (January 18, 2019), 25 pts were enrolled (part 1, n = 9; part 2, n = 16). Median age was 63 (range, 32-79) y; 16 pts were men; 24 pts discontinued therapy, mainly due to disease progression (n = 21). Most common tumors were esophageal (n = 5) and cholangiocarcinoma (n = 3). No dose-limiting toxicities occurred; the RP2D was 13.5 mg QD (intermittent dosing). Most common adverse events (AEs) were hyperphosphatemia (n = 19), dysgeusia (n = 9), alopecia (n = 8), constipation, diarrhea, nausea, and decreased appetite (each, n = 7); most frequent grade ≥3 AEs were anemia, cholangitis, and decreased appetite (each, n = 2). One pt with metastatic adenocarcinoma and FGFR2 amplification had a partial response (ongoing at cutoff); 9 pts had stable disease. At 13.5 mg, steady-state geometric mean (%CV) maximum concentration was 159 nmol/L (88.5%), area under the curve was 2300 h·nmol/L (58.5%), and terminal half-life was 14.0 h (42.1%). Conclusions In these Japanese pts with advanced malignancies, the pemigatinib tolerability profile is consistent with previous reports; pharmacokinetics are similar to Western populations. Recruitment is ongoing. [ABSTRACT FROM AUTHOR] |
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