Onconova Therapeutics, Inc.
) recently provided results on its most advanced candidate,
rigosertib, from the phase III study, ONTIME.
Rigosertib failed to meet its primary endpoint of significant
improvement in median overall survival compared to best
supportive care (BSC) in the ONTIME study. The multi-center,
randomized, controlled ONTIME study evaluated patients with
higher risk myelodysplastic syndromes (MDS) who had progressed
on, failed or relapsed after prior therapy with hypomethylating
The median overall survival of 8.2 months for IV rigosertib
plus BSC arm was not statistically significant when compared to
5.8 months for placebo.
However, the effects of the treatment were seen in certain
subgroups. In a subgroup of patients who had progressed on or
failed previous treatment with HMAs, the median overall survival
was 8.5 months for IV rigosertib plus BSC arm compared with 4.7
months for placebo.
Further analysis is underway to identify potential survival
benefit in other subsets of patients.
Additional details from the ONTIME study will be presented at
the annual meeting of the American Society of Clinical Oncology
Onconova is developing rigosertib in partnership with
Baxter International Inc.
) (commercialization rights in Europe) and SymBio Pharmaceuticals
(Japan and Korea). Onconova will commercialize in all other
Rigosertib is also being evaluated in a phase III study
for metastatic pancreatic cancer, phase II study for
transfusion-dependent lower risk MDS, and a phase II study
for head and neck cancers.
Onconova carries a Zacks Rank #3 (Hold). We expect investors
to react negatively to this news. The stock is down in pre-market
Investors looking for better-ranked stocks in the biopharma
sector may consider companies like
Biogen Idec Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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