Pfizer’s leukaemia drug beats chemotherapy in Phase III trials

pharmafile | June 13, 2016 | News story | Research and Development, Sales and Marketing Inotuzumab ozogamicin, Pfizer, acute lymphoblastic leukaemia 

Pfizer (NYSE: PFE) has announced data from a pivotal Phase III trial for acute lymphoblastic leukaemia (ALL) drug, inotuzumab ozogamicin, which showed improvement over chemotherapy in areas such as haematologic remission and progression-free survival.

The INO-VATE late-stage trial achieved both of its primary endpoints with complete response – or the disappearance of all signs of cancer in response to treatment – in 80.7% of patients treated with inotuzumab ozogamicin compared to 29.4% of patients on chemotherapy. The drug also showed significant improvements in progression free survival with a rate of five months versus 1.8 months.

Hagop M. Kantarhian, lead study investigator, comments: “These results suggest inotuzumab ozogamicin, if approved, could be a valuable new addition to currently available treatment options for ALL patients, including as a bridge to stem cell transplantation, which is the best chance for a cure at this stage of the disease.”

The drug was granted breakthrough therapy status by the US Food and Drug Administration (FDA) last October. With these latest results, Pfizer hopes to win over the FDA and other regulatory authorities to approve the drug in this indication.

Mace Rothenberg, chief development officer in oncology at Pfizer, says: “To see remission rates and two-year survival rates that are more than doubled compared to standard of care chemotherapy is very gratifying. We believe these data add to the growing body of evidence that supports inotuzumab ozogamicin as an important potential treatment option in adults with relapsed or refractory ALL.”

The results of this pivotal late-stage trial were presented at the 21st congress of the European Haematological Association (EHA) annual meeting in Copenhagen, Denmark.

Inotuzumab ozogamicin previously met with disappointment in 2013 when a Phase III trial investigating its use in non-Hodgkin lymphoma (NHL) was abandoned early.

Sean Murray

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