United Therapeutics (NASDAQ:UTHR) announces that Unituxin (dinutuximab) failed to achieve the primary endpoint in a Phase 2/3 clinical trial, DISTINCT,
evaluating the GD-2 targeting monoclonal antibody, combined with chemo
agent irinotecan, in patients with relapsed/refractory small cell lung
cancer (SCLC).
The combination failed to extend overall survival (OS) compared to irinotecan or topotecan alone.
No new safety signals were observed.
Complete data will be submitted for presentation at future medical conferences and publication.
The FDA OK’d Unituxin in March 2015 for pediatric
high-risk neuroblastoma. It is also pursuing a label expansion to use
Unituxin, combined with irinotecan and temozolomide, for pediatric
patients with relapsed/refractory neuroblastoma. It expects to meet with
the FDA in H1 and file a supplemental marketing application shortly
thereafter.
https://seekingalpha.com/news/3537157-united-therapeutics-dinutuximab-flunks-cancer-study
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