Trial hitch for Pfizer’s leukaemia drug submission plans
pharmafile | December 7, 2010 | News story | Research and Development, Sales and Marketing | CML, Gleevec, Glivec, Pfizer, bosutinib, chronic myeloid leukaemia
Pfizer is pressing ahead with plans to submit bosutinib for European approval despite the chronic myeloid leukaemia drug missing its primary endpoint in a late-stage head-to-head trial.
Just days after announcing it would seek a European marketing licence for bosutinib next year based on findings from the BELA trial, it reported the drug had only met a secondary endpoint in that study.
Bosutinib failed to meet its primary endpoint, which was to reach superior complete cytogenetic response (CCyR) rate at one year versus Novartis’ Glivec (imatinib).
Commenting on the study results Dr Mace Rothenberg, senior VP of clinical development and medical affairs for Pfizer’s oncology business unit, said: “Based on the totality of evidence from the bosutinib clinical development programme, we are actively engaged in discussions with regulatory authorities which we hope will enable Pfizer to offer a new treatment option for patients with chronic myeloid leukaemia.”
Bosutinib is being trialed as a second line treatment for chronic myeloid leukaemia (CML), which is one of the four main types of leukaemia and accounts for around 15% of all blood cancers worldwide.
The BELA trial is an ongoing, phase III, randomised, open-label study of bosutinib versus Glivec in 500 newly diagnosed patients with Ph+ CML.
Despite failing to reach its primary endpoint, bosutinib did reach its secondary endpoint in the trial.
This saw a significantly higher proportion of patients with newly diagnosed CML who were treated with bosutinib (39%) experiencing a major molecular response (MMR), compared with patients treated with Glivec (26%) in the intent-to-treat population.
Dr Carlo Gambacorti-Passerini, professor of internal medicine and director of the clinical research unit at the University of Milano Bicocca in Italy, and a lead investigator of the BELA study, said: “We are encouraged by these data, as they demonstrate early and meaningful response to bosutinib in patients with newly diagnosed CML.
“Given the length of time these patients are treated for CML, we need more therapeutic options to choose from since each patient is different and has different needs.”
Bosutinib is an investigational oral dual Src and Abl kinase inhibitor. It is believed that by dual inhibition of the Src and Abl proteins, bosutinib may inhibit signaling in CML cells that allows the cells to grow, survive and reproduce.
US regulatory submission plans for bosutinib
Pfizer says it has also had discussions with the FDA regarding a possible regulatory submission in the US for bosutinib for use in previously treated chronic phase Philadelphia chromosone positive (Ph+ CML) patients.
This submission would be based on the pending two-year efficacy and safety data in the primary cohort of Study 200, which consists of more than 200 previously treated CML patients.
Study 200 is a single arm study of bosutinib in over 500 patients with previously treated Ph+ CML, including patients resistant or intolerant to Novartis’ Glivec as well as patients who have become refractory to Bristol-Myers Squibb’s CML drug Sprycel (dasatinib) or Novartis’ primary leukaemia drug Tasigna (nilotinib).
Currently, there are no approved second-line therapies available for CML patients who fail on Sprycel or Tasigna.
Ben Adams
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