Agios Pharmaceuticals, Inc. (AGIO - Free Report) announced new data from the dose expansion part of a phase I study, evaluating its IDH1 mutant inhibitor, ivosidenib (AG-120), as a single agent for treating low grade isocitrate dehydrogenase-1 mutant (IDH1m) glioma. Data was presented at the annual meeting of the Society for Neuro-Oncology (“SNO”) in San Francisco.
Agios’ shares have significantly outperformed the industry so far this year. The stock has surged 42.9% compared with the industry’s rally of 22.5%.
The new data from the dose expansion part demonstrated durable stable disease and reduction of tumor growth rates for patients with low grade glioma. The median progression free survival was 13 months. The median treatment duration was 16 months on treatment with ivosidenib, comparing favorably to the pre-treatment interval of 9.6 months.
Notably, the phase I study is assessing the safety and tolerability of ivosidenib in advanced solid tumors, including glioma, intrahepatic cholangiocarcinoma and chondrosarcomas that harbor an IDH1 mutation.
Per the press release, the company also presented preclinical data, evaluating ivosidenib and its pan-IDH mutant inhibitor, AG-881, in an orthotopic mouse xenograft model of human mIDH1-R132H glioma as posters. Data from the study demonstrated that ivosidenib and AG-881 resulted in suppression of 2-hydroxyglutarate (2-HG) levels in brain tumor mouse models.
Notably, earlier the company had announced that it plans to initiate a perioperative window study to evaluate ivosidenib and AG-881 in low grade glioma for investigating their effects on brain tumor tissue in the first half of 2018.
We remind investors that Agios is conducting a phase I/II study in combination with Celgene's (CELG - Free Report) Vidaza for treatment of newly diagnosed AML patients, not eligible for intensive chemotherapy. The FDA granted an orphan drug designation to ivosidenib for treatment of AML patients. The company said that it is on track to submit a new drug application (NDA) to the FDA for ivosidenib by this year-end.
Ivosidenib is also being evaluated in a phase III study to evaluate ivosidenib in front-line AML patients with an IDH1 mutant-positive advanced cholangiocarcinoma.
Zacks Rank & Key Picks
Agios carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector include Ligand Pharmaceuticals Inc. (LGND - Free Report) and Achillion Pharmaceuticals, Inc. (ACHN - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Ligand’s earnings per share estimates have moved up from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 8.22%. Share price of the company has surged 30.7% year to date.
Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.
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