Home / FDA News / Pfizer’s Antibody-Drug Conjugate Succeeds in Phase 3 Study and its Xalkori Receives Breakthrough Therapy Designation

Pfizer’s Antibody-Drug Conjugate Succeeds in Phase 3 Study and its Xalkori Receives Breakthrough Therapy Designation

Pfizer Inc. announced positive news for two of its cancer drugs today. The company said that US health regulators granted its Xalkori (crizotinib) Breakthrough Therapy designation, and, separately, Pfizer announced that its investigational antibody-drug conjugate (ADC) met one of its main goals in a late-stage leukemia trial.

The US Food and Drug Administration (FDA) granted Pfizer’s Xalkori Breakthrough Therapy status for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). ROS1-positive NSCLC occurs in approximately one percent of NSCLC cases. It represents a particular molecular subgroup of NSCLC. Breakthrough status will expedite the drug’s development and review.

Xalkori is already approved in the US for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

“We are excited that the FDA has granted Breakthrough Therapy designation for Xalkori as a potential treatment for patients with ROS1-positive NSCLC,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “Xalkori pioneered precision medicine for ALK-positive metastatic NSCLC, and ROS1 represents a second molecular subgroup of NSCLC in which Xalkori has demonstrated a level of anti-tumor activity that can potentially make a real difference for patients.”

Separately, the company announced that its inotuzumab ozogamicin met its first primary endpoint of demonstrating a higher complete hematologic remission rate in patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) compared to that achieved with standard of care chemotherapy in a Phase III study, called INO-VATE. The study’s other primary endpoint is overall survival (OS). According to Pfizer, data on OS is not available yet, and therefore the company is continuing the study to allow the data to mature.

Inotzumab ozogamicin is an investigational ADC comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it’s internalized into the cell where the cytotoxic agent is released to destroy the cell. The drug was originally developed by Celltech, now UCB after a $2.25 billion acquisition.

In May of 2013, Pfizer discontinued its Phase III study evaluating the investigational ADC in patients with relapsed or refractory aggressive Non-Hodgkin Lymphoma (NHL) after an independent committee concluded that the drug would not meet the primary objective of improving OS. Now, the company hopes to present positive safety and efficacy data from its ALL study at an upcoming medical meeting.

“We are excited about the results of the INO-VATE ALL study especially since relapsed and refractory acute lymphoblastic leukemia is a particularly difficult disease to treat in adults. The top-line results show that inotuzumab ozogamicin has the potential to be an important new treatment option for patients with relapsed refractory disease,” said Dr. Rothenberg. “We look forward to discussing these data with the FDA and other regulatory authorities.”

Source: Pfizer Inc.

Last updated: 4/21/15; 11:05am EST

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