The National Comprehensive Cancer Network (NCCN) has been awarded two individual $2 million grants from GlaxoSmithKline (GSK) to support clinical studies of two anticancer agents. The trials will involve ofatumumab in hematologic malignancies and pazopanib in solid tumors.
Ofatumumab is marketed as Arzerra for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. It received FDA accelerated approval in October 2009. NCCN will evaluate the therapy in various lymphomas including follicular, mantle cell, diffuse large B-cell, and non-Hodgkin lymphomas. Ofatumumab is already being testing in multiple Phase II and III studies in B-cell and follicular lymphomas as well as CLL.
Pazopanib was also sanctioned in October 2009 by the FDA to treat advanced renal cell carcinoma and is branded Votrient. The research grant to NCCN will evaluate the effectiveness of pazopanib in solid tumors including renal, sarcoma, thyroid, neuroendocrine, and ovarian cancers.
Pazopanib has reached Phase II and III trials in breast, non-small-cell lung, and head and neck cancers as well as sarcoma. The candidate is also being evaluated as a treatment for age-related macular degeneration.
Arzerra and Votrient each recorded sales of £13 million (about $20.28 million) during the first half of the year. Besides the arrangement with NCCN to expand the franchise of these two drugs, GSK is also working with Genmab to expand Arzerra’s use. The most recent amendment to their agreement, which came in July, means that GSK has responsibility for developing ofatumumab in autoimmune indications, while the firms will continue to work together on ofatumumab in oncology indications. Ofatumumab is in a Phase II trial for multiple sclerosis and Phase III for rheumatoid arthritis.
Genmab received £90 million up-front. Its future funding commitment for the development of ofatumumab in oncology indications will be capped at £145 million, including a yearly spending cap of £17 million for each of the next six years starting with 2010. Future milestones due to Genmab under the oncology development program will be reduced by 50%.
The NCCN Oncology Research Program (ORP) facilitates all phases of clinical research by identifying clinical investigators and initiating trials at NCCN Member Institutions. It draws on the expertise of investigators at 21 cancer centers and establishes collaborations with pharmaceutical and biotech companies to advance therapeutic options for patients with cancer. The ORP will use the grants from GlaxoSmithKline to support investigator-initiated clinical and correlative studies at its NCCN Member Institutions for both drugs.