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Agios Pharma (AGIO) to complete Phase 1 Study of AG-881 in patients with Hematologic Malignancies With an IDH1 or IDH2 Mutation in Q1 2018

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Additional Information

Additional Relevant Details AG-881 is an orally available inhibitor of the mutated IDH1 and IDH2 proteins. In preclinical studies, it has shown to fully penetrate the blood-brain barrier, which has potential to support ongoing development efforts to provide treatment options to patients with glioma. It also represents a possible second-generation molecule for both AG-221 and AG-120 in IDH mutant tumors.
http://www.agios.com...
Clinical Data
  • Forty-eight percent of patients (n=25) had World Health Organization (WHO) classified Grade 2 tumors, 42% (n=22) had Grade 3 tumors, 8% (n=4) had Grade 4 tumors and 2% (n=1) was unknown.
  • Ninety-two percent of patients (n=48) had an IDH1 mutation and 6% (n=3) had an IDH2 mutation. One patient did not have a biopsy but was confirmed as IDH mutant positive due to 2-HG elevation by magnetic resonance spectroscopy (MRS).
  • The median age of these patients is 42.5 years (ranging from 16-73 years).
  • Patients received a median of two prior systemic therapies (ranging from one to six).
      -- Seventy-three percent of patients (n=38) had previously received temozolomide and 58% percent (n=30) had previously received radiotherapy.
  • Patients received daily doses of AG-881 ranging from 10 mg to 300 mg.
  • The median treatment duration was seven months (ranging from 0-27 months) for all glioma patients, 12 months (ranging from 1-27 months) for non-enhancing glioma and 3 months (ranging from 0- 27 months) for patients with enhancing disease.
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    Related Keywords Phase 1 Study, Ag-881, Hematologic Malignancies, Idh1 Mutation, Idh2 Mutation, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Open-label