On September 1, 2017 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that updated data from the ongoing Phase 1b trial of FP-1039/GSK3052230 (hereafter FP-1039) in mesothelioma patients were reported today in an abstract submitted to the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress to be held Sept. 8 – 12, 2017, in Madrid, Spain (Press release, Five Prime Therapeutics, SEP 1, 2017, View Source [SID1234520361]). The abstract titled "Multicenter, Nonrandomized, Open-Label Phase 1b Study of FP-1039/GSK3052230 with Chemotherapy: Results in Malignant Pleural Mesothelioma (MPM)" by Dr. Jose Trigo et al. is available at View Source

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The MPM arm of the study evaluated the safety and efficacy of FP-1039 (IV weekly) in combination with standard pemetrexed + cisplatin. The study design involved dose escalation until maximum tolerated dose (MTD) followed by a cohort expansion phase. Endpoints included safety, overall response rate by modified RECIST 1.1, disease control rate (DCR), progression free survival (PFS) and exploratory translational objectives.

As of the cutoff date of March 17, 2017, 36 patients were dosed at 10, 15 and 20 mg/kg doses of FP-1039. Three DLTs were observed at 20 mg/kg but none occurred at 15 mg/kg; therefore, MTD was declared at this dose.

Safety Data

The most common adverse events (AEs; all grades) observed were: nausea (56%) decreased appetite (36%), fatigue (33%) and infusion reaction (33%).
Efficacy Data

The confirmed objective response rate (ORR) of all evaluable patients at or below the MTD was 48%, with 13 partial responses in 27 patients.

The disease control rate (DCR) was 100%.

The median PFS was 7.4 months.
As of May 8, 2017, six patients stayed on the study for over 1 year, of which three were still ongoing.

About FP-1039

FP-1039 is a protein drug designed to intervene in FGF signaling. As a ligand trap, FP-1039 binds to FGF ligands circulating in the extracellular space (such as FGF2), preventing these signaling proteins from reaching FGFR1 on the surface of tumor cells. Treatment with FP-1039 has not been shown to cause hyperphosphatemia, a side effect seen with small molecule inhibitors of FGF receptors, which block the activity of both cancer-associated FGFs and FGF-23. GlaxoSmithKline (GSK) was the sponsor of the trial.