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Area of Science:

  • Hematology
  • Oncology
  • Molecular Biology

Background:

  • Myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangements (MLN-FGFR1) are aggressive hematologic malignancies.
  • These neoplasms are driven by constitutive FGFR1 activation due to chromosome 8p11 rearrangements.
  • Current treatment options for MLN-FGFR1 are limited, highlighting the need for novel therapeutic strategies.

Purpose of the Study:

  • To evaluate the efficacy and safety of pemigatinib, an FGFR1-3 inhibitor, in patients with MLN-FGFR1.
  • To assess pemigatinib's response rates, including complete response and complete cytogenetic response.
  • To analyze treatment outcomes based on disease phase (chronic vs. blast phase).

Main Methods:

  • A phase 2, single-arm study (FIGHT-203) enrolled patients with confirmed MLN-FGFR1.
  • Patients received oral pemigatinib 13.5 mg once daily in a 2-weeks-on/1-week-off or continuous schedule.
  • Primary endpoint was complete response rate; secondary endpoints included complete cytogenetic response rate and safety.

Main Results:

  • The overall complete response rate was 74% (31/42), with 96% in chronic-phase and 44% in blast-phase patients.
  • A complete cytogenetic response was achieved in 73% (33/45) of patients.
  • Hyperphosphatemia (76%) was the most common adverse event; stomatitis (19%) was the most common grade 3+ event.

Conclusions:

  • Pemigatinib demonstrated significant efficacy in chronic-phase MLN-FGFR1, achieving near-complete responses.
  • The drug showed a notable response rate in blast-phase patients, suggesting therapeutic potential.
  • Pemigatinib was generally manageable with dose modifications, indicating a favorable safety profile.