Expert Interview
Discussing Incyte’s Pemazyre (Pemigatinib) for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement, following FDA Approval
Ticker(s): INCYInstitution: Hummingbird Biotherapeutics
- Chief Medical Officer (part-time) of Hummingbird Biotherapeutics (formerly CMO at ImClone and Stemline Therapeutics).
- Focused on the comprehensive development and registration strategies of cancer therapeutics of all types; integrally involved with the development and registration of more than 12 cancer therapeutics.
- While at Johns Hopkins University School of Medicine, he performed seminal clinical development and pharmacologic studies on paclitaxel, docetaxel, irinotecan, topotecan, among other agents; has published approximately 315 manuscripts in both the nonclinical and clinical research fields.
Please describe your clinical trial practice, in particular about neoplasm patients, how many present with refractory myeloid/lymphoid/ Fibroblast Growth Factor Receptor1 rearrangement?
Could you please give us an introduction into selective fibroblast growth factor receptor inhibitors, and your hands-on impressions, and the role of FGFR in cancer ?
Could you talk with us about the competitive space in this area, for example Pyrimidinyl Ureas as FGFR Inhibitors, dovitinib, Imidazopyridine-Based Inhibitors, Quinoxaline- and Naphthyridine-Based Inhibitors, etc. Which have the most promising prospects and why?
Added By: catalin_adminCan you please discuss the data that supported FDA approval of Pemazyre, f.ex. The CR rate of 78 and 104 days median time to response, how does it compare to standard of care?
Please discuss the AEs, of hyperphosphatemia (74%), nail toxicity (62%), alopecia (59%), stomatitis (53%), diarrhea (50%), dry eye (50%), fatigue (44%), rash (35%), abdominal pain (35%), anemia (35%), constipation (32%), dry mouth (32%), epistaxis (29%), retinal pigment epithelial detachment (26%), extremity pain (26%), decreased appetite (24%), dry skin (24%), dyspepsia (24%), back pain (24%), nausea (21%), blurred vision (21%), peripheral edema (21%) and dizziness (21%). Are any of these results concerning?
Common (≥10%) Grade 3 or 4 laboratory abnormalities were decreased phosphate, decreased lymphocytes, decreased leukocytes, decreased platelets, increased alanine aminotransferase, and decreased neutrophils. How likely is this to impact the use of Pemigatinib?
How convincing is Pemazyre’s cytogenetic response in patients with chronic phase disease and in patients with blast phase disease, to you?
How likely are you to use Pemazyre for your patients starting from now?
Added By: catalin_adminAre You Interested In These Questions?
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