Pfizer's Cancer Drug Meets First Primary Endpoint in Phase III - Analyst Blog

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Pfizer Inc. PFE announced that an open-label, randomized, phase III study (INO-VATE ALL or Study 1022) on pipeline candidate inotuzumab ozogamicin met the first primary endpoint by demonstrating a higher complete hematologic remission rate in patients suffering from relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) compared to standard-of-care chemotherapy.

The study is evaluating the safety and efficacy of inotuzumab ozogamicin versus a defined set of chemotherapy options (including the combination of Fludara, Cytosar and G-CSF (FLAG); high dose Cytosar (HIDAC); or a Cytosar/Novantrone combination) in adult patients suffering from relapsed or refractory CD22-positive ALL.

The study has two primary endpoints – complete hematologic remission rate and overall survival. The company is pursuing the study in order to obtain mature data on overall survival. The study is now completely enrolled.

Based on top-line results, Pfizer stated that inotuzumab ozogamicin has the potential to become a new treatment option for patients suffering from relapsed or refractory ALL. Positive top-line result from the INO-VATE ALL study is encouraging. Given that the five-year overall survival rate in relapsed or refractory ALL patients is as low as less than 10%, we believe there is a need for new therapies in this market.

Meanwhile, Pfizer, which has a strong presence in the field of oncology, is currently working towards the label expansion of Xalkori for ROS1-positive non small cell lung cancer (NSCLC). The drug is already approved for the treatment of metastatic NSCLC in patients whose tumors are anaplastic lymphoma kinase positive.

Earlier this week, the FDA granted Breakthrough Therapy status to Xalkori for potential treatment of patients suffering from ROS1-positive NSCLC. With this designation, the development of Xalkori and its review process in the new indication will be accelerated.

Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Biogen Inc. BIIB, Horizon Pharma plc HZNP and Amgen Inc. AMGN. All these stocks carry a Zacks Rank #1 (Strong Buy).


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