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Pfizer Halts Inotuzumab Study

Zacks Equity Research

Pfizer Inc. (PFE) 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 well.

Companies that currently look well-positioned include Salix Pharmaceuticals, Ltd. (SLXP), Jazz Pharmaceuticals (JAZZ) and Santarus, Inc. (SNTS). All three are Zacks Rank #1 (Strong Buy) stocks.

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