Five Prime Therapeutics announces abstract with updated data in mesothelioma patients from ongoing phase 1b trial of FP-1039 at ESMO 2017 Congress (34.34 +0.42)
- 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.
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