Pfizer abandons cancer trial
pharmafile | May 22, 2013 | News story | Research and Development, Sales and Marketing | Cancer, Inotuzumab ozogamicin, Pfizer, oncology
Pfizer’s oncology pipeline has suffered a blow with the company abandoning a Phase III study of one of its investigational compounds in non-Hodgkin lymphoma (NHL).
Inotuzumab ozogamicin was being looked at in patients with relapsed or refractory aggressive NHL who could not receive intensive high-dose chemotherapy.
Pfizer has insisted it will continue to test the drug in other blood cancers but an independent data monitoring committee in effect called time on the trial, when its interim analysis said the primary endpoint of improving overall survival (OS) would not be reached.
Patients were given the drug once a month in combination with rituximab and the results were compared with an active comparator arm, in which patients either had bendamustine plus rituximab or gemcitabine plus rituximab.
“We are working to better understand the findings from this review to determine if there are any patterns of outcome that may help us gain greater understanding of the potential effect of inotuzumab ozogamicin in specific patient subsets within the heterogeneous patient population enrolled in this trial,” said Dr Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s oncology business unit.
NHL is contracted by around 350,000 people worldwide each year, and there were more than 190,000 deaths related to the disease in 2008.
In aggressive cases, standard of care achieves long-term remission in less than half of patients, which means that there is an unmet need for both those who are newly diagnosed and relapsed, Pfizer suggests.
Inotuzumab ozogamicin comprises a monoclonal antibody targeting CD22, a cell surface antigen expressed on 90% of B-cell malignancies, linked to the cytotoxic agent calicheamicin. When it binds to CD22 it releases calicheamicin to destroy the cell.
The company has told study investigators and regulators of its decision to stop the trial and says it will work with the patients involved to decide what they should do next.
“Haematologic cancers are a complex group of diseases, with more than 70 different types of lymphomas, leukemias or myelomas that require unique treatment options,” said Rothenberg.
“We remain committed to evaluating inotuzumab ozogamicin in patients with hematologic malignancies,” he added.
Adam Hill
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