Agios AG-120 efficacy data in low-grade gliomas has experts cautiously optimistic but extensive follow-up needed to convince

21 Nov 2016

Agios’ (NASDAQ:AGIO) AG-120 has generated cautious expert optimism following minor responses (MR) and stable disease (SD) responses in recent Phase I data for low-grade gliomas.

It is too early to say definitively whether the drug is benefiting patients, but responses thus far are considered to be of benefit due to the indolent nature of the diseases, experts said, speaking on the sidelines of the data presentation at the Society for NeuroOncology (SNO) annual meeting, on 17 November.

Analysts note the data is difficult to interpret and the drug’s potential in solid tumors remains unclear, based on the limited amount of efficacy data in gliomas and the lack of objective responses in chondrosarcoma.

The study (NCT02073994) – which initiated in March 2014 -- has a target enrollment of 145 patients and is recruiting those with gliomas, chondrosarcoma, cholangiocarcinoma and other advanced solid tumors carrying IDH1 mutations and due to complete in August 2017. The drug is an IDH1 inhibitor for gliomas that harbor the mutations, which are present in 68-74% of low-grade glioma and secondary glioblastoma, according to Agios’ website.

A couple more years of follow-up should make it clearer whether the benefit is real, and if patients continue to show MR and SD after nine or 10 years, it will be considered a success, they said. However, some also said stronger responses would have been more desirable, and disease stabilization in particular does not indicate potent drug activity.

Analysts predict global sales of the drug to reach USD 408m by YE25, according to BioPharm Insight data.

Agios did not respond to a request for comment.

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