– Oral presentation to highlight clinical data for olutasidenib, an investigational agent, in IDH1 mutant gliomas, including confirmation of blood-brain barrier penetration and preliminary disease control for patients with recurrent, predominantly enhanced glioma –
WATERTOWN, Mass. – May 28, 2020 – Forma Therapeutics, Inc. (“Forma”), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that two abstracts for the company’s investigational IDH1m inhibitor, olutasidenib, have been accepted as part of the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program taking place May 29-31, 2020.
The abstracts, currently available on the ASCO website, are:
Abstract Number 2505
Oral Presentation: A phase 1b/2 study of olutasidenib in patients with relapsed/refractory IDH1 mutant gliomas: Safety and efficacy as a single agent and in combination with azacitidine.
Date and Time: Available on ASCO’s website beginning May 29, 2020, at 8:00 a.m.
Oral Abstract Session: Central Nervous System Tumors
Presenter: Macarena de la Fuente, M.D., Sylvester Cancer Center, University of Miami
Abstract Number e16643
Online Publication: A phase 1b/2 study of olutasidenib in patients with relapsed/refractory IDH1 mutant solid tumors: Safety and efficacy as a single agent.
Dr. de la Fuente will present findings regarding olutasidenib monotherapy in 26 patients (23 enhancing, three non-enhancing) with confirmed IDH1 gene-mutated advanced glioma, including data that indicate:
- Olutasidenib, dosed twice daily at 150 mg, was well-tolerated in patients with mIDH1 glioma and no dose-limiting toxicities were observed with monotherapy;
- As dosed, olutasidenib demonstrated clinically relevant concentrations in the cerebrospinal fluid, confirming the blood-brain barrier penetration observed in preclinical models;
- Olutasidenib demonstrated a preliminary disease control rate of 50% in heavily pre-treated patients with predominantly enhancing, recurrent mIDH1 glioma, specifically:
- One patient achieved a partial response, per investigator assessment by response assessment in neuro-oncology (RANO)
- Four patients achieved tumor reduction greater than 50%, per a blinded independent central volumetric assessment (BICR)
- Nine patients exhibited stable disease for more than four months
“These data indicate that olutasidenib is well-tolerated and may provide clinical benefit in patients with recurrent glioma, a patient population with very limited treatment options,” said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics.
Copies of the abstracts and the oral presentation will be available on Forma’s website here upon presentation at the meeting.
About Olutasidenib, or FT-2102
Olutasidenib is an oral, potent and small molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. Forma is currently evaluating olutasidenib in a registrational Phase II trial for relapsed/refractory AML and in an exploratory Phase I trial for glioma.
IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.
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