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Pfizer next-gen lung cancer med called breakthrough by FDA

May 1, 2017

The U.S. Food and Drug Administration (FDA) granted Pfizer (PFE)’s lorlatinib Breakthrough Therapy designation to treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK inhibitors.

Lorlatinib is a next-generation ALK/ROS1 tyrosine kinase inhibitor. In preclinical studies, it was shown to be highly active in lung cancer models represented by chromosome rearrangements of both ALK and ROS1. The compound was engineered to inhibit tumor mutations that drive resistance to other ALK inhibitors. It was also designed to penetrate the blood brain barrier.

ALK gene rearrangements drive lung cancer in some patients. Because more mutations may occur during treatment, patients with ALK-positive metastatic NSCLC face a challenging treatment environment.

“This regulatory designation recognizes the potential for lorlatinib to provide an important treatment option for patients with ALK-positive NSCLC whose cancers have progressed despite treatment,” said Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development, in a statement. “Pfizer’s rapid development of lorlatinib reflects a commitment to developing biomarker-driven therapies to meet the evolving needs of patients. We look forward to working with the FDA to accelerate the development of this therapy.”

Breakthrough Therapy designation is designed to expedite the development and review of certain therapeutics for serious or life-threatening diseases when preliminary data shows it be a big improvement over existing treatments.

In addition, Pfizer announced that its Phase III CROWN clinical trial comparing lorlatinib to crizotinib in the first-line treatment of patients with metastatic ALK-positive NSCLC has begun to enroll patients.

In other news, Pfizer entered into a deal with Schlieren, Switzerland-based InSphero AG to develop a novel predictive toxicology assay using InSphero 3D InSight Human Liver Microtissues. The in vitro assay will leverage the enhanced sensitivity and longevity of InSphero 3D liver models in hopes of multiplexing several endpoints to detect and predict mechanisms of drug toxicity.

“Our 3D liver models enable researchers to better predict potential toxicity and side-effects using more biologically relevant cell based assays,” said Jan Lictenberg, InSphero’s co-founder and chief executive officer, in a statement. “These models may also help reduce dependency on animal models, which add significant cost, delay time to market, and often fail to accurately reflect how humans will respond to a drug. We already have a long-standing relationship with Pfizer and this new agreement will enable the development of assays with potentially even greater utility and predictive power for Pfizer’s early drug development.”

The project will be conducted by InSphero scientists in Brunswick, Maine and Schlieren, Switzerland, with input from Pfizer researchers.

Otherwise, investors are eager for Pfizer’s first-quarter 2017 earnings report on May 2. In the last quarter of 2016, the company reported earnings of 6 percent. New products such as Xalkori for lung cancer, Xeljanz for rheumatoid arthritis and Ibrance for breast cancer, should contribute to top-line results, along with old standbys like Lyrica for neuropathic pain. And there are expectations about the sales of Xtandi, the prostate cancer drug the company picked up when it acquired Medivation (MDVN) in September 2016.

However, the open question is how those pluses will work against patent losses on Zyvox and Celebrex, as well as the expiration of a couple co-promotion deals. And Enbrel is being battered by competition from biosimilars.

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