GlaxoSmithKline (GSK) and Genmab announced the start of a Phase III study in patients with indolent B-cell non-Hodgkin’s lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen
London, UK, Copenhagen, Denmark | September 8, 2010 | GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the start of a Phase III study in patients with indolent B-cell non-Hodgkin’s lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen. Under the terms of Genmab’s collaboration with GlaxoSmithKline (GSK), Genmab will receive a milestone payment of approximately DKK 116 million (approximately USD 20 million), triggered by the treatment of the first patient in the study.
About the trial
A total of 338 patients in this open label study will be randomized to receive either ofatumumab in addition to bendamustine or bendamustine alone. The primary endpoint of the study is progression free survival. Patients in the bendamustine monotherapy group will have the opportunity to receive ofatumumab if their lymphoma progresses.
About Indolent B-Cell Non-Hodgkin’s Lymphoma
More than one-third of lymphoma patients have indolent B-cell non-Hodgkin’s lymphoma, which includes follicular lymphoma and other typically slow growing lymphomas which initially respond to treatment but relapse with time.(1) Indolent B-NHL is defined by expression of the CD20 molecule, which is the target of monoclonal antibodies such as rituximab and ofatumumab.2,3)
About ofatumumab
Ofatumumab is a human monoclonal antibody which targets CD20. Ofatumumab is not approved in any country for indolent B-cell non-Hodgkin’s lymphoma (B-NHL).
References
1. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review 1975-2006 , National Cancer Institute.
2. McLaughlin, Peter. Mayo Clinic Hematology/Oncology Review: Part 1 Progress and Promise in the Treatment of Indolent Lymphomas. The Oncologist, June 2002 Vol. 7, No. 3, 217-225.
3. Cheson, Bruce D. Ofatumumab, a Novel Anti-CD20 Monoclonal Antibody for the Treatment of B-Cell Malignancies. Journal of Clinical Oncology. July 20, 2010 vol.28 no. 21 3525-3530.
SOURCE: GlaxoSmithKline (GSK) and Genmab A/S
Post Views: 110
GlaxoSmithKline (GSK) and Genmab announced the start of a Phase III study in patients with indolent B-cell non-Hodgkin’s lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen
London, UK, Copenhagen, Denmark | September 8, 2010 | GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the start of a Phase III study in patients with indolent B-cell non-Hodgkin’s lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen. Under the terms of Genmab’s collaboration with GlaxoSmithKline (GSK), Genmab will receive a milestone payment of approximately DKK 116 million (approximately USD 20 million), triggered by the treatment of the first patient in the study.
About the trial
A total of 338 patients in this open label study will be randomized to receive either ofatumumab in addition to bendamustine or bendamustine alone. The primary endpoint of the study is progression free survival. Patients in the bendamustine monotherapy group will have the opportunity to receive ofatumumab if their lymphoma progresses.
About Indolent B-Cell Non-Hodgkin’s Lymphoma
More than one-third of lymphoma patients have indolent B-cell non-Hodgkin’s lymphoma, which includes follicular lymphoma and other typically slow growing lymphomas which initially respond to treatment but relapse with time.(1) Indolent B-NHL is defined by expression of the CD20 molecule, which is the target of monoclonal antibodies such as rituximab and ofatumumab.2,3)
About ofatumumab
Ofatumumab is a human monoclonal antibody which targets CD20. Ofatumumab is not approved in any country for indolent B-cell non-Hodgkin’s lymphoma (B-NHL).
References
1. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review 1975-2006 , National Cancer Institute.
2. McLaughlin, Peter. Mayo Clinic Hematology/Oncology Review: Part 1 Progress and Promise in the Treatment of Indolent Lymphomas. The Oncologist, June 2002 Vol. 7, No. 3, 217-225.
3. Cheson, Bruce D. Ofatumumab, a Novel Anti-CD20 Monoclonal Antibody for the Treatment of B-Cell Malignancies. Journal of Clinical Oncology. July 20, 2010 vol.28 no. 21 3525-3530.
SOURCE: GlaxoSmithKline (GSK) and Genmab A/S
Post Views: 110
