- Agios Pharmaceuticals (NASDAQ:AGIO) is up 3% premarket, albeit on only 283 shares, on the heels of its announcement of updated results from the dose expansion cohort of a Phase 1 study assessing single-agent ivosidenib in patients with progressive low-grade isocitrate dehydrogenase-1-mutant (IDH1m) glioma, a tumor that originates in the brain or spinal cord. The data were presented at the Society for Neuro-Oncology Annual Meeting in San Francisco.
- 35 patients have been treated with ivosidenib. 51% (n=18/35) remain on treatment.
- 6% (n=2/35) experienced a minor response and 83% (n=29/35) had stable disease. Median progression-free survival (PFS) for all non-enhancing (less aggressive cancer) patients was 13 months. Median PFS for Grade 2 (slowest growing type of glioma) patients (n=24) has not been reached.
- No dose-limiting toxicities were observed. Most adverse events were mild or moderate. The most common were headache, nausea, diarrhea and vomiting. There were five serious adverse events reported, non related to treatment.
- The company plans to launch a perioperative "window" study of ivosidenib and AG-881, a brain-penetrant pan-IDH inhibitor, in H1 2018.
- Orphan Drug- and Fast Track-tagged ivosidenib is an orally available inhibitor of mutated IDH1 protein, a metabolic enzyme that is overexpressed in a range of cancers.
- Now read: Conatus Pharmaceuticals (CNAT) Presents At Stifel 2017 Healthcare Conference - Slideshow
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