) recently faced a pipeline setback with the company
discontinuing a late-stage study being conducted with its
oncology candidate, inotuzumab ozogamicin.
The randomized, open-label, two-arm phase III study was being
conducted in patients suffering from relapsed or refractory CD22+
aggressive non-Hodgkin lymphoma (NHL) who are not eligible for
intensive high-dose chemotherapy. A once-monthly dose of
inotuzumab plus Rituxan (rituximab) was evaluated for safety and
efficacy versus an active comparator arm (Treanda + Rituxan or
Gemzar + Rituxan).
Based on a scheduled interim analysis, an independent Data
Monitoring Committee (DMC) said that the inotuzumab arm was not
likely to achieve the primary endpoint of overall survival.
Pfizer said that no new safety issues were observed.
Pfizer said that it has informed the study investigators as
well regulatory authorities about the discontinuation of the
study. The company, however, intends to continue studying
inotuzumab for hematologic cancers.
Inotuzumab is currently in an open-label, randomized phase III
study (INO-VATE ALL) that is being conducted in adult patients
with acute lymphoblastic leukemia.
The discontinuation of the phase III study is disappointing as
inotuzumab is a key pipeline candidate at Pfizer.
Pfizer currently carries a Zacks Rank #3 (Hold). The company's
pipeline needs to deliver given the Lipitor loss of exclusivity
and the upcoming loss of exclusivity on additional products in
the next few years. In addition to genericization, revenues will
be hit by the expiration of a few co-promotion agreements as
Companies that currently look well-positioned include
Salix Pharmaceuticals, Ltd.
). All three are Zacks Rank #1 (Strong Buy) stocks.
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