Discussion
tumor, PK/PD
TUMOR, SOLID TUMORS
The safety and efficacy with pemigatinib has been previously reported in Chinese patients with CCA [The PK data indicated rapid absorption of pemigatinib in Chinese patients and consistent PK parameters between single and multiple dosing. Pemigatinib exposures at steady state in this study were generally consistent with previous data in Western population (INCB 54828–101) [Preliminary anti-tumor activity was observed with pemigatinib in this previously treated patient population: 3 out of 12 patients achieved SD and 2 of 12 patients achieved PR. The overall efficacy of pemigatinib in the Chinese patients was similar to Western patients as reported in the phase I/II Fight-101 study (Supplement Table Accumulating data suggest that FGF/FGFR alterations are associated with tumor sensitivity to FGFR inhibitors although their underlying role has not been fully elucidated [The safety results showed that the investigated pemigatinib regimen was generally well tolerated in Chinese patients with FGF/FGFR-altered solid tumors. Most TEAEs were grade 1–2 in severity and were manageable with supportive care; only 1 out of 12 patient needed dose reduction. The safety profile was generally consistent with previous data from Western patients and Japanese patients treated with pemigatinib [Limitations exist in this study. Firstly, as the study was designed as an open-label phase I study, the data had inherent limitations. In addition, the sample size was small with only 12 patients enrolled into the study. Speaking of different tumor types, the number of patients enrolled is even more limited.In conclusion, in this phase I study, pemigatinib had similar PK/PD characteristics to western population and an acceptable safety profile in Chinese patients, with no new safety signals identified. Preliminary promising antitumor activity was observed in Chinese patients with FGF/FGFR1-3 altered, advanced, solid tumors.