Celgene Corp has been boosted by late-stage data which shows that Abraxane, currently approved for breast and lung cancer, extends survival in patients with advanced pancreatic cancer.
A Phase III study of Abraxane (nanoparticle albumin-bound -'nab' - paclitaxel) in combination with gemcitabine in treatment-naive patients with advanced pancreatic cancer met its primary endpoint of overall survival, compared to patients receiving gemcitabine alone. Full results from the trial, which included 861 patients, will be presented at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium in January.
Celgene said that based on the results, it plans to submit dossiers for registration in the USA, Europe and other markets. The positive data comes a month after Abraxane was approved by the US Food and Drug Administration for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in combination with carboplatin; the drug was approved for breast cancer in 2005.
Analysts are impressed with the pancreatic cancer data. Geoffrey Porges at Sanford Bernstein issued a research note, noting that the data has come out earlier than expected "and will come as a surprise to many investors and analysts". He added that "it has become almost axiomatic in the oncology world that 'nothing works in pancreatic cancer' and this trial has certainly proven an exception to that rule".
The data also went down well with the Pancreatic Cancer Action Network in the USA. Chief executive Julie Fleshman noted that "historically, few effective treatment options for pancreatic cancer have existed. We are thrilled to have a new treatment option [and] look forward to learning more about the increase in survival when the full results from the study are released".