"We look forward to enhancing this important grants program in 2017 to further support investigator-initiated efforts in both breast and hematologic cancers where there is a substantial need for research that may lead to improved care," said Graciela Mabel Woloj, PhD, senior director, Medical Affairs, Pfizer Oncology. "Supporting research projects that advance medical and scientific knowledge about our therapies is at the cornerstone of our commitment to meeting the needs of the cancer community."
Investigators in the United States are encouraged to submit proposals for innovative clinical research that evaluates select Pfizer compounds and that is aimed at advancing knowledge in the treatment and disease management of breast cancer as well as hematologic malignancies. Proposals should include IBRANCE® (palbociclib), an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, for metastatic breast cancer, the most advanced stage of breast cancer (stage IV); Mylotarg (gemtuzumab ozogamicin), an investigational antibody-drug conjugate (ADC) targeting CD33, for acute myeloid leukemia (AML),, the most common leukemia in adults; and inotuzumab ozogamicin, an investigational ADC targeting CD22, for acute lymphoblastic leukemia (ALL), a rapidly progressing blood cancer with the lowest five-year survival rate among all leukemias.
Pfizer also announced the 2016 ASPIRE Breast Cancer Research Award recipients, who were selected through a competitive application process overseen by an independent review panel of breast cancer experts. Four grants totaling more than $3 million in funding were awarded to investigators in the United States in support of clinical research projects investigating IBRANCE. The following investigators and studies have been awarded grants:
- Drs. Ingred Mayer and Carlos Arteaga, Vanderbilt University School of Medicine - Phase Ib trial of Fulvestrant, Palbociclib (CDK 4/6 Inhibitor) and Erdafitinib (JNJ-42756493, pan-FGFG tyrosine kinase inhibitor) in ER+/HER2-/FGFR- amplified metastatic breast cancer
- Dr. Amy Tiersten, Mount Sinai School of Medicine - Multicenter, Phase I/II Trial of Arimidex, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast Cancer
- Drs. Elena Shagisultanova and Virginia Borges, University of Colorado-Denver - Phase Ib/II Open-Label Single Arm Study to Evaluate Safety and Efficacy of ONT-380 in Combination with Palbociclib and Letrozole in Patients with Hormone Receptor-Positive and HER2-Positive Metastatic Breast Cancer.
The $5.5 million (USD) allocated for the 2017 ASPIRE Oncology/Hematology Clinical Research Awards will fund six to eight studies. The proposal submission period ends March 31, 2017.
For more information about the 2017 ASPIRE Oncology/Hematology Clinical Research Awards and to submit your proposal, please visit www.aspireresearch.org.
About IBRANCE® (palbociclib)
IBRANCE is the first and only FDA approved oral inhibitor of CDKs 4 and 6, which are key regulators of the cell cycle that trigger cellular progression.,
IBRANCE is indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) advanced or metastatic breast cancer in combination with letrozole as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.6 The indication in combination with letrozole is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
About Mylotarg (Gemtuzumab Ozogamicin)
Mylotarg is an investigational ADC comprised of the cytotoxic agent calicheamicin attached to a monoclonal antibody (mAB) that targets CD33, an antigen expressed on the surface of leukemic blasts in more than 80 percent of AML patients.,, When Mylotarg binds to the CD33 antigen on leukemia cells it is absorbed into the cell, at which point the cytotoxic agent calicheamicin is released to destroy the cell.,
About Inotuzumab Ozogamicin
Inotuzumab ozogamicin is an investigational ADC comprised of a mAb targeting CD22, a cell surface antigen found on cancer cells in almost all B-ALL patients, linked to a cytotoxic agent., When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is thought to be internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.
Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people's lives.
Pfizer Inc.: Working together for a healthier worldTM
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.
1 National Cancer Institute. What you need to know about™ breast cancer. http://www.cancer.gov/publications/patient-education/WYNTK_breast.pdf (link is external). Updated August 2012. Accessed October 20, 2015.
2. Tanaka M, Kano Y, et al. The Cytotoxic Effects of Gemtuzumab Ozogamicin (Mylotarg) in Combination with Conventional Antileukemic Agents by Isobologram Analysis In Vitro. Anticancer Research. 2009; 29: 4589-4596.
3. Griffin JD, Linch D, Sabbath K, et al: A monoclonal antibody reactive with normal and leukemic human myeloid progenitor cells. Leuk Res 8: 521-534, 1984 CrossRefMedline.
4 National Cancer Institute: Adult Acute Lymphoblastic Leukemia Treatment (PDQ®) - General Information About Adult Acute Lymphoblastic Leukemia (ALL). Available at:http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1(link is external) (link is external). Accessed March 21, 2016.
5. Deschler, B. and Lübbert, M. (2006), Acute myeloid leukemia: Epidemiology and etiology. Cancer, 107: 2099–2107. doi: 10.1002/cncr.22233.
6. IBRANCE® (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2016.
7. Weinberg RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329.
8. Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.
9. Burnett A. Treatment of acute myeloid leukemia: are we making progress? American Society of Hematology. Available at: http://asheducationbook.hematologylibrary.org/content/2012/1/1.full.pdf (link is external). Accessed on October 2, 2016.
10. National Cancer Institute. General Information About Adult Acute Myeloid Leukemia. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adultAML/healthprofessi... (link is external). Accessed on October 2, 2016.
11. Tanaka M, Kano Y, et al. The Cytotoxic Effects of Gemtuzumab Ozogamicin (Mylotarg) in Combination with Conventional Antileukemic Agents by Isobologram Analysis In Vitro. Anticancer Research. 2009; 29: 4589-4596.
12. Burnett A. Treatment of acute myeloid leukemia: are we making progress? American Society of Hematology. Available at: http://asheducationbook.hematologylibrary.org/content/2012/1/1.full.pdf (link is external). Accessed on October 2, 2016.
13. National Cancer Institute. General Information About Adult Acute Myeloid Leukemia. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adultAML/healthprofessi... (link is external). Accessed on October 2, 2016.
14. National Cancer Institute: Adult Acute Lymphoblastic Leukemia Treatment (PDQ®) – General Information About Adult Acute Lymphoblastic Leukemia (ALL). Available at:http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1(link is external) (link is external). Accessed March 21, 2016.
15. Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical Cancer Research. 2004; 10: 5327-5334.
16. DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and Rituximab against Non-Hodgkin's B-Cell Lymphoma. Clin Cancer Res. 2006; 12: 242-250.