June 1, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Pfizer Inc. ’s breast cancer drug Ibrance taken in combination with an estrogen-treatment therapy developed by AstraZeneca PLC slowed the progression of the most common forms of the disease by more than nine months, the company announced this morning as part of its attendance at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
In the drug’s latest clinical trial, dubbed PALOMA-3, which studied 521 patients who saw their cancer return after initial treatment for the disease, those patients treated with a combination of Ibrance and AstraZeneca’s Faslodex (fulvestrant), saw progression free survival of a median of 9.2 months until the cancer progressed. Those who only took Faslodex and a placebo went an average of 3.2 months before their cancer progressed. Pfizer said the study, which will be presented later today during ASCO, could be a “promising treatment option for women with HR+, HER2- metastatic breast cancer after progression on endocrine therapy.” The median age of the patients in the study was about 57.
“The results of PALOMA-3 are compelling and provide evidence that could potentially expand the role of palbociclib as an innovative first-in-class therapy for patients with metastatic breast cancer,” Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said in a statement.
Pfizer stopped clinical trials of Ibrance in April, two months ahead of time, after the company announced the trials endpoints of delaying progression of the disease had already been met. Overall survival results were not yet available, Pfizer said. During the clinical trial the most common adverse events reported for the palbociclib-fulvestrant group were neutropenia, leukopenia, fatigue and nausea.
In February the U.S. Food and Drug Administration (FDA) approved Ibrance (palbociclib) to treat advanced (metastatic) breast cancer, but only for patients who had not yet received an endocrine-based therapy Ibrance works by inhibiting molecules involved in promoting the growth of cancer cells, cyclin-dependent kinase 4 and 6.
Ibrance was approved to be used in combination with letrozole, another FDA-approved product manufactured by Novartis AG and sold under the name Femara, which is used to treat certain kinds of breast cancer in postmenopausal women. It wasn’t until 2008 that Pfizer scientists thought to combine Ibrance with letrozole and target a specific type of breast cancer.
In 2013 the FDA granted Ibrance breakthrough therapy designation base on trial evidence the drug provided a substantial improvement over available therapies, according to the FDA. The drug was given a priority review status with a review date set for next month, but the federal agency approved the drug prior to its two-year review mark.
Breast cancer in women is the second most common type of cancer in the United States. The National Cancer Institute (NCI) estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014. About 75 percent of all breast cancers are hormone receptor-positive, HER2-negative, Nicholas Turner, the study’s lead author said.
Pfizer sad it is in talks with regulatory agencies to determine next steps to potentially make palbociclib available for women with HR+, HER2- metastatic breast cancer whose disease has progressed following endocrine therapy. As previously disclosed, Pfizer intends to file a Marketing Authorization Application for palbociclib to the European Medicines Agency in the second half of 2015. In addition, Pfizer said it will work closely with the FDA to review the data and determine next steps for potential inclusion in the U.S. label. Some analysts predict the breast cancer drug could earn $3 to $5 billion in revenue for the New York-based pharmaceutical giant.
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?
