At Pfizer, Even the Biggest Biosciences Company Finds Room to Grow in Oncology

Ben Leach
Published: Tuesday, Nov 29, 2011
Denise Bruns

Denise Bruns, PhD

When it comes to market capital, Pfizer, Inc. tops a list of major companies in the biosciences market. Following its acquisition of Wyeth Pharmaceuticals in 2009, Pfizer now has 14 blockbuster drugs, or drugs that generate at least $1 billion each in annual revenue for the company.

Despite a wide range of products that cover a number of diseases and ailments, the company’s oncology division is still finding new ways to meet unmet needs for cancer patients. In fact, several products in the company’s pipeline are Pfizer’s first forays into certain tumor types.

Pfizer currently has 18 new molecular entities in various stages of clinical trials, and 2 of them—crizotinib for non–small cell lung cancer (NSCLC) and axitinib for advanced renal cell carcinoma (RCC)—have been registered with the FDA. In addition, 5 of those compounds are in clinical trials for diseases outside of their primary indication.

“If you look at our oncology portfolio about 3 years ago, we had sunitinib and not much else,” said Denise Bruns, PhD, late-phase development group leader in clinical development and medical affairs at Pfizer. “Today, we have a lot more phase III clinical trials, especially after the addition of the Wyeth portfolio.”

Our oncology division is determined to find which of these therapeutic agents are most likely to benefit the patients. ”
–Denise Bruns, PhD
Bruns said that, going forward, part of the oncology division’s plan is to try and steer clear from all-cancer treatments and focus on those that have known genetic markers, thereby allowing the creation of more targeted therapies for more specific tumor types.

For example, inotuzumab ozogamicin, a humanized monoclonal antibody for the CD22 molecule, is currently in a phase III trial for treating aggressive non-Hodgkin lymphoma. A phase II trial is also underway to see if inotuzumab can be used for treating indolent non-Hodgkin lymphoma. Bruns said inotuzumab and the recently approved crizotinib, which will be marketed by Pfizer as Xalkori, are 2 of the first drugs that the company has developed for the treatment of blood cancer.

“Our goal is to become the new standard of care and be able to go against [Roche’s] Tarceva,” Bruns said. Despite a more focused approach, it doesn’t necessarily mean that some of the therapeutic agents under development will be limited to 1 tumor type. In June, axitinib, a vascular endothelial growth factor receptor tyrosine kinase inhibitor, was accepted for review by the FDA for the treatment of advanced RCC based on the results of phase III clinical trial data. Axitinib is also currently in a phase III trial to test its efficacy in treatment-naïve advanced RCC patients, as well as a phase II clinical trial to determine if it can be used to treat patients with lung cancer or thyroid cancer.

Table. Pfizer's Phase II/III Oncology Drug Pipeline

Drug Name/Compound Mechanism of Action Indication(s) Phase
Sunitinib malate Multiple tyrosine kinase inhibitor Islet cell tumors of the pancreas Registration in US; approved in EU in December 2010
Axitinib VEGF tyrosine kinase inhibitor Renal cell carcinoma Phase III
Bosutinib Abl and src-family kinase inhibitor Chronic myelogenous leukemia Phase III
Crizotinib c-MET-ALK inhibitor Lung cancer, cancerb Phase III
Inotuzumab ozogamicina   Aggressive non-Hodgkin lymphoma Phase III
Neratinib Pan-HER inhibitor Breast cancer Phase III
PF-00299804 Pan-HER inhibitor Lung Cancer Phase III
Sunitinib malate Multiple tyrosine kinase inhibitor Renal cell carcinoma, adjuvant Phase III
Temsirolimus Islet cell tumors of the pancreas Renal cell carcinoma Phase III
Axitinib FKBP-rapamycin-associated protein Lung and thyroid cancers Phase II
Inotuzumab ozogamicin   Indolent non-Hodgkin lymphoma Phase II
PD-0332991   Cancer Phase II
PF-00299804   Cancer Phase II
PF-01367338   Cancer Phase II
Tremelimumab   Genitourinary and gastrointestinal cancers, melanoma, renal cell carcinomab, pancreatic cancerb Phase II
aThe project is either new or has progressed in phase since Pfizer's previous portfolio update.
bAdditional indications in phase I.
     New molecular entity
     New indication or enhancement
ALK indicates anaplastic lymphoma kinase; c-MET, mesenchymal-epithelial transition; HER, human epidermal growth factor receptor; VEGF, vascular endothelial growth factor.
This focused approach has already proven its worth in 2011. In August, the FDA approved crizotinib for the treatment of patients with ALK-positive NSCLC. To ensure that only patients with the ALK-positive form of the disease receive the drug, the patients are required to undergo a genetic test. Even though the American Society of Clinical Oncology estimates that only about 8% of NSCLC patients are ALK-positive, Pfizer claimed that crizotinib will succeed because it will be prescribed only to those most likely to benefit from it.

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