8/26/2014 6:42:25 AM
Drug Giants Merck & Co., Inc. And Pfizer Inc. Forge Cancer Pact
August 26, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Pfizer Inc. (PFE), the New York, New York-based pharmaceutical corporation, and Merck & Co., Inc. (MRK) [known as MSD outside the United States and Canada], the White House Station, NJ-based pharmaceutical corporation, today announced a clinical trial collaboration to test Merck’s Investigational Anti-PD-1 Antibody Pembrolizumab and Pfizer’s Crizotinib (XALKORI®) in combination for patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC). Neither company released the financial terms of the agreement, however, Pfizer will run the study, which will be a multi-center, open label clinical study scheduled to begin in early 2015.
“Understanding the effects of combining one drug, XALKORI®, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body’s immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology.
The Phase Ib trial will be initiated because, according to Dr. Eric Rubin, vice president, Oncology, Merck Research Laboratories, “Evidence from early studies of pembrolizumab monotherapy together with XALKORI®’s proven targeted therapeutic approach provides the scientific rationale for evaluating this combination for the treatment of lung cancer.”
Pfizer’s XALKORI® is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Merck describes Pembrolizumab (MK-3475) as “an investigational, humanized, monoclonal antibody against PD-1 designed to reactivate anti-tumor immunity.” The company estimates that by the end of 2014, the pembrolizumab development program will include more than 24 clinical trials involving an estimated 6,000 patients in nearly 300 locations worldwide.
Just yesterday, Merck and Advaxis (ADXS), the Princeton, NJ-based clinical-stage biotechnology company, announced a collaboration for a Phase I/II clinical trial to evaluate the safety and efficacy of Advaxis’ ADXS-PSA as a standalone treatment and also in combination with Merck’s pembrolizumab in patients with previously treated metastatic prostate cancer.
In an article published yesterday, Reuters claims that three sources have indicated that the FDA is “likely to approve” pembrolizumab as a treatment for melanoma “within coming weeks,” and “well ahead of a late October deadline.” Should pembrolizumab be approved, it will be the “first in a promising new class of drugs,” referred to as immuno-oncology drugs, that strengthen the power of the body’s immune system to destroy cancer cells.
According to Reuters, “Some analysts expect the new class could generate more than $30 billion in annual sales worldwide by 2025.”
In addition to Pfizer and Advaxis, Merck is collaborating with Amgen, GlaxoSmithKine and Incyte for the clinical testing of pembrolizumab.
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