Market Overview

Agios Pharma Reports Initiation of Phase 1/2 Clinical Trial of AG-221 in Patients with Advanced Solid Tumors with IDH2 Mutation


Agios Pharmaceuticals,
Inc. (Nasdaq: AGIO), a leader in the fields of cancer metabolism and rare
genetic disorders of metabolism, today announced the initiation of a Phase 1/2
multicenter study of AG-221 in patients with advanced solid tumors, including
gliomas, as well as angioimmunoblastic T-cell lymphoma (AITL) that carry an
isocitrate dehydrogenase-2 (IDH2) mutation. The study will enroll patients who
have recurred or progressed following standard therapy or have not responded
to prior standard therapy. This is the second trial to be initiated in
patients with cancer as part of AG-221's clinical development program, which
includes the ongoing Phase 1 trial with four expansion cohorts in patients
with hematologic malignancies.

Preclinical evidence shows that mutant IDH2 enzyme, the target of AG-221,
produces 2-hydroxyglutarate (2HG), which blocks the normal maturation of
progenitor cells. In solid tumor cells expressing the IDH2 mutation, AG-221
inhibited the production of 2HG, which has the potential to affect
differentiation and cell proliferation in patients with solid tumors. In
addition, AG-221 has demonstrated an acceptable safety profile and evidence of
antitumor activity in the ongoing Phase I trial of AG-221 in patients with
advanced hematologic malignancies that carry an IDH2 mutation.

"Evaluating AG-221 in patients with advanced solid tumors is an important next
step in our efforts to understand the potential of this investigational
medicine to treat a broad range of cancers with the IDH2 mutation," said Chris
Bowden M.D., chief medical officer at Agios. "The safety, pharmacokinetics,
clinical activity, and effect on the biomarker 2HG we have observed from the
different dose levels studied in the Phase 1 trial for advanced hematologic
malignancies give us insights into the potential to fight cancer in patients
with advanced solid tumors. AG-221 will only be evaluated in prospectively
defined patients whose cancers carry an IDH2 mutation, and who we believe have
the greatest potential to benefit from treatment."

Posted-In: News FDA Press Releases


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