In an oral presentation at ESMO (European Society for Medical Oncology), Five Prime Therapeutics (FPRX) recently provided updated data from the ongoing Phase 1B trial of FP-1039, a drug in development for use in mesothelioma patients (MPM), notes biotech expert John McCamant, editor of The Medical Technology Stock Letter.
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The mesothelioma arm of the open-mark Phase 1B trial evaluated weekly infusions of FP-1039, an FGF ligand trap, in combination with first-line pemetrexed and cisplatin chemotherapy in patients with untreated, unresectable MPM.
The primary study endpoints are safety and overall response rate (ORR), disease control rate (DCR) at 6 months, progression free survival (PFS) and exploratory translational objectives. The poster includes data from MPM patients who had received FP-1039 as of the 17-Mar-17 cut-off.
In the 27 patients evaluable as of March 17, 2017, who had received FP-1039 at or below the 15 mg/kg MTD dose level: Preliminary ORR was 48%, with six-month DCR of 81%.
Safety was also excellent with the most common adverse events across all dose levels (AEs; all grades) observed were: nausea (56%), decreased appetite (36%), fatigue (33%) and infusion reaction (36%). The vast majority of events were Grades 1-2.
Toxicities associated with small-molecule FGFR inhibitors, such as hyperphosphatemia, retinal detachment and nail bed changes, have not been observed.
FPRX also presented an oral poster discussion featuring preclinical data for FPA150, a novel B7-H4 antibody.
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