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Researchers Receive Grants from NCCN Oncology Research Program Funded Through GlaxoSmithKline

The NCCN Oncology Research Program received $4 million in research funding from GlaxoSmithKline to support research at NCCN Member Institutions in order to evaluate the effectiveness of ofatumumab (Arzerra®, GlaxoSmithKline) in hematologic malignancies and pazopanib (Votrient™, GlaxoSmithKline) in the treatment of solid tumors.

FORT WASHINGTON, PA — The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) recently awarded research grants to investigators following a review of proposals submitted in response to the NCCN Ofatumumab Request for Proposals and the NCCN Pazopanib Request for Proposals. These grants were made possible through general research support of $4 million from GlaxoSmithKline.

NCCN is pleased to announce that we will be funding five new ofatumumab research studies and seven pazopanib research studies in 2011, in addition to more than 50 active clinical and correlative trials that we are already supporting, commented Diane Paul, MS, RN, Vice President, ORP, NCCN. Research grants enable NCCN and our member institutions to work with industry to help develop and bring scientific discoveries to market for the benefit of all patients. We are grateful for the opportunity to work with GlaxoSmithKline to make important strides in research possible.

The U.S. Food and Drug Administration (FDA) granted approval of ofatumumab for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. In addition to CLL, the clinical trials at NCCN Member Institutions supported by the grant will further evaluate the therapy`s effect in various lymphomas, including follicular, mantle cell, diffuse large B-cell, and non-Hodgkin`s lymphomas.

The following proposals for ofatumumab have been awarded funding:

• Jennifer Brown, MD, PhD,Dana-Farber Cancer Institute, Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab for the Treatment of 17p Deletion Chronic-Lymphocytic Leukemia.
• Alessandra Ferrajoli, MD, The University of Texas MD Anderson Cancer Center, Phase II Study of Ofatumumab as Front-Line Treatment in Elderly, Unfit Patients with Chronic Lymphocytic Leukemia (CLL).
• Francisco Hernandez-llizaliturri, MD, Roswell Park Cancer Institute, Ofatumumab in Combination with High Dose Cytarabine Chemoimmunotherapy for Patients with Newly Diagnosed Mantle Cell Lymphoma (MCL).
• Shuo Ma, MD, PhD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Correlative Studies in Conjunction with A Phase 2 Trial of Alemtuzumab-Ofatumumab Combination in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL).
• Taimur Sher, MD, Roswell Park Cancer Institute, A Multicenter Phase II Study of Ofatumumab in Combination with Bortezomib in Previously Untreated Patients with Waldenström Macroglobulinemia.

Pazopanib is currently approved by the FDA to treat patients with advanced renal cell carcinoma. The research grant to NCCN will evaluate the effectiveness of pazopanib in solid tumors, including sarcoma, thyroid, and neuroendocrine cancers.

The following proposals for pazopanib have been awarded funding:

• Nilofer S. Azad, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, A Phase I Study Determining the Safety and Tolerability of Combination Therapy with Pazopanib, a VEGFR/PDGFR/Raf Inhibitor, and GSK 1120212, a MEK Inhibitor, in Advanced Solid Tumors Enriched with Patients with Advanced Differentiated Thyroid Cancer.
• Laura QM Chow, MD, Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, A Phase I Clinical Trial of Pazopanib in Combination with Escalating Doses of Radioactive 131I in Patients with Well-Differentiated Thyroid Carcinoma Refractory to Radioiodine, Despite Having Some Uptake.
• Herbert I. Hurwitz, MD, Duke Cancer Institute, Phase I Dose Escalation of Pazopanib Plus TH302 in Advanced Solid Tumors Followed by an Expanded Cohort in Pancreatic Neuroendocrine Tumors.
• Halla Nimeiri, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, A Phase I/II Study of the Combination of Temozolomide and Pazopanib in Advanced Pancreatic Neuroendocrine Tumor (PNET).
• Gary K. Schwartz, MD, Memorial Sloan-Kettering Cancer Center, A Phase IB/II Study of Pazopanib in Conjunction with Gemcitabine and Docetaxel (gem/doce/pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS).
• Margaret von Mehren, MD, Fox Chase Cancer Center, Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma.
• Jennifer J. Wheler, MD, The University of Texas MD Anderson Cancer Center, Phase I Combination of Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients with Advanced Solid Tumors Refractory to Standard Therapy.

The awardees responded to Requests for Proposals issued by the NCCN ORP to the 21 NCCN Member Institutions. Submissions were peer reviewed by the NCCN Ofatumumab Scientific Review Committee and the NCCN Pazopanib Scientific Review Committee. The awardees were selected based on several key components, including scientific merit, existing data, and the types of studies necessary to further evaluate the activity of the drugs.

The NCCN Oncology Research Program (ORP) draws on the expertise of investigators at NCCN Member Institutions to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer. The NCCN ORP will utilize the grant from GlaxoSmithKline to support investigator-initiated clinical and correlative studies at its NCCN Member Institutions for ofatumumab and pazopanib. To date, this successful research model has received more than $34 million in research grants and provided 87 investigators with funding for clinical and correlative trials that have produced numerous publications in peer-reviewed journals.