Pfizer to present data on hematology portfolio at ASH Annual Meeting

Pfizer (NYSE: PFE) said today that new data on investigational compounds in its hematology portfolio will be presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, December 4-7.  Key highlights include results from a Phase 3 study, called the BELA (Bosutinib Efficacy and safety in chronic myeloid LeukemiA) study, involving bosutinib for the treatment of newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). The company will also present Phase 2 data from inotuzumab ozogamicin (CMC-544) for the treatment of B-cell Non-Hodgkin lymphoma (NHL). These presentations underscore the company's commitment to advancing new treatments for patients living with various hematologic malignancies, which represent the second leading cause of cancer death.

Pfizer also announced that it would initiate an open-label, randomized, Phase 3 study, Study B1931008, of inotuzumab ozogamicin administered in combination with rituximab compared to defined investigator's choice therapy in subjects with relapsed or refractory CD22-positive aggressive NHL who are not candidates for intensive high-dose chemotherapy. This study will be open and enrolling in early 2011.

"We believe that the investigational agents in our portfolio have the potential to make a difference in the lives of patients with CML and NHL," said Dr. Len Mattano, Vice President, Tumor Strategy Lead for Pfizer's Oncology Business Unit. "Pfizer is committed to improving outcomes for patients living with hematologic cancers where unmet needs exist and is proud of our progress toward meeting these goals."  

Pfizer will present data on several key candidates from its hematologic portfolio at ASH.  These include:

Bosutinib

Bosutinib is an investigational, oral dual Src and Abl kinase inhibitor. It is believed that by dual inhibition of the Src and Abl tyrosine kinases, bosutinib may inhibit signaling in CML cells that allows the cells to grow, survive and reproduce.

Presentations on bosutinib include:

• Oral presentation, Abstract #208, December 6.

An ongoing, Phase 3 randomized, open-label study of bosutinib versus imatinib in newly diagnosed patients with chronic phase Ph+ CML.(1)

• Oral presentation, Abstract #892, December 7.

Data from a cohort of a Phase 1/2 single-arm study (Study 200) of bosutinib in patients with chronic phase Ph+ CML, who have failed prior imatinib therapy and were resistant or intolerant to dasatinib or resistant to nilotinib. Study 200 is an ongoing Phase 1/2 study in patients with Ph+ CML being treated in the second and third-line setting.

• Poster presentation, Abstract #3434, December 6.

Data from a Phase 1/2 study (Study 200) of hematologic and cytogenetic response rates in patients with or without Bcr-Abl mutations.

Inotuzumab Ozogamicin

Inotuzumab ozogamicin is an investigational antibody-targeted cytotoxic targeting CD22, an antigen expressed in approximately 90 percent of B-cell malignancies. Linking an antibody with a cytotoxic agent is designed to direct chemotherapy to selected cancer cells expressing the CD22 antigen. This targeted delivery is intended to result in less toxicity compared to non-targeted systemic delivery of currently used cytotoxic chemotherapy.

Presentations on inotuzumab ozogamicin include:

• Oral presentation, Abstract #430, December 6.

Preliminary details of Study 2001, a Phase 2 safety and efficacy study evaluating inotuzumab ozogamicin (CMC-544) in patients with indolent B-cell NHL, the most common type of NHL, that are relapsed or refractory to rituximab alone, rituximab in combination with chemotherapy or radioimmunotherapy (RIT) will be presented.

• Poster presentation, Abstract #2883, December 5.

Results from Study 2005, a Phase 2 safety and efficacy study of inotuzumab ozogamicin (CMC-544) plus rituximab followed by high dose therapy and autologous stem cell transplant (HDT-aSCT) in relapsed/refractory NHL patients including diffuse large B-cell lymphoma (DLBCL) patients.

• Poster presentation, Abstract #2872, December 5.

Safety, pharmacokinetics, and preliminary efficacy of inotuzumab ozogamicin (CMC-544) in combination with rituximab in Japanese patients with relapsed or refractory B-cell NHL.

Additional Early Stage Data

Data on additional Pfizer compounds being studied in hematologic malignancies will also be presented:

• Oral presentation, Abstract #860, December 6.

A Phase 1 trial evaluating PD 0332991 in combination with bortezomib or dexamethasone in relapsed or refractory multiple myeloma. PD 0332991 is a selective inhibitor of cyclin-dependent kinase (CDK) 4/6.(12)

• Poster presentation, Abstract #2877, December 5.

Safety and activity of crizotinib (PF-02341066), an oral ALK inhibitor, in patients with ALK-positive anaplastic large cell lymphoma (ALCL) resistant to cytotoxic therapy.

Crizotinib NSCLC Data Chosen for ASH/ASCO Joint Symposium

Pfizer will also present updated data as part of the ASH/ASCO Joint Symposium session from the Part 2 expanded cohort Phase 1 trial of crizotinib in patients with ALK-positive advanced non-small cell lung cancer (NSCLC) (December 5). Crizotinib (PF-02341066) is a first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK, and is representative of Pfizer's personalized medicine approach to cancer treatment. By inhibiting ALK, crizotinib (PF-02341066) blocks signaling in a number of cell pathways that may be critical for the growth and survival of tumor cells. Crizotinib (PF-02341066) is also an inhibitor of c-MET (mesenchymal endothelial transition factor).

These data will be presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, December 4-7, 2010.