OncoMed Pharma Crashes 40% After Poor Trial Data

Shares of Oncomed Pharmaceuticals Inc OMED plunged 42 percent during Monday's pre-market session after the company provided an update on its Phase 2 ALPINE clinical trial following a pre-planned January 23 interim efficacy assessment of the clinical trial by an independent data safety monitoring board (DSMB).

According to Oncomed's press release, the DSMB concluded that the trial should proceed to completion without modification. However, the DSMB informed the company of several negative findings.

One of the findings included: "A statistically significant worsening of response rate and progression-free survival (PFS) in the treatment arm in the overall intent-to-treat population, as well as a negative trend in each Notch biomarker subgroup."

A second finding included: "A strong trend to lack of benefit in the treatment arm for overall survival (OS), regardless of Notch biomarker levels, suggesting a low probability of achieving a statistically significant OS benefit based on analyses reviewed by the DSMB."

"The findings communicated by the DSMB suggest a low likelihood of a statistically significant benefit in overall survival in the tarextumab ALPINE pancreatic cancer trial," said Paul J. Hastings, Chairman and CEO. "Our aim is to quickly unblind the trial and work with our clinical sites and investigators to verify, analyze, interpret, and fully understand the data, including Notch biomarker subgroup trends, and determine next steps."

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Posted In: NewsHealth CareMoversGeneralALPINECancer DrugsData Safety Monitoring BoardOncoMedPaul Hastingspharmaceuticals
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